A Phase 3 interventional study of Ibrexafungerp in Invasive Candidiasis, Mucocutaneous Candidiasis and Coccidioidomycosis, sponsored by Scynexis, Inc.. Completed at 37 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by Scynexis, Inc. · Phase 3, Interventional, and Treatment
This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy and safety of ibrexafungerp (SCY-078) in patients ≥ 18 years of age with a documented fungal disease that has been intolerant or refractory (rIFI) to Standard of Care (SoC) antifungal treatment.
This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy and safety of ibrexafungerp in patients ≥ 18 years of age with a documented invasive and/or severe fungal disease that has been intolerant or refractory (rIFI) to Standard of Care (SoC) antifungal treatment. Patients will be treated with ibrexafungerp for up to 180 days. Treatment beyond 180 days and combination therapy with other antifungal agents may be allowed under special circumstances to be agreed upon by the Investigator and the Sponsor.
Subjects must have a proven or probable fungal disease and meet all study criteria to be considered for enrollment. Eligible subjects must also have documented evidence of failure of, intolerance to, or toxicity related to a currently approved SoC antifungal treatment.
Subjects will also be considered for enrollment if they have an eligible fungal disease and, in the judgement of the investigator, the subject cannot receive approved oral antifungal options (e.g. susceptibility of the organism or risk for drug-drug interactions) and a continued IV antifungal therapy is not desirable or feasible due to clinical or logistical circumstances.
Following a screening visit, there will be up to 15 treatment visits, a follow-up visit and 2 follow-up contacts.
65 studies on the registry are indexed under Candidiasis, Invasive; 6 are open to participants now.
This study's enrollment of 233 is above the median of 60 across 47 interventional studies indexed under Candidiasis, Invasive.
Browse Candidiasis, Invasive studies →Scynexis, Inc. is the lead sponsor of 18 studies on the registry; none are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 10 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.
Drug: Ibrexafungerp
Experimental Study Drug
Also known as: SCY-078
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease.
The percentage of participants who achieve Global Response (defined as complete or partial response) as determined by the DRC at disease specific timepoints by fungal disease. Global Response is measured by participant survival and overall effect of treatment on the disease. Complete response: Survival, all attributable signs/symptoms (including radiological) resolved and myoclogical eradication of disease; Partial response: Survival, improvement of attributable signs/symptoms (including radiological). Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases.
Time frame: Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category
The percentage of participants who achieve a Global Response (defined as complete or partial response) as determined by the DRC by enrollment category, at disease specific timepoints. Global Response is measured by participant survival and overall effect of treatment on the disease. Complete response: Survival, all attributable signs/symptoms (including radiological) resolved and myoclogical eradication of disease; Partial response: Survival, improvement of attributable signs/symptoms (including radiological). Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Participants may have been enrolled for more than 1 enrollment reason.
Time frame: Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category.
The percentage of participants who achieve Global Response (defined as complete or partial response) as determined by the DRC at disease specific timepoints by disease category. Global Response is measured by participant survival and overall effect of treatment on the disease. Complete response: Survival, all attributable signs/symptoms (including radiological) resolved and myoclogical eradication of disease; Partial response: Survival, improvement of attributable signs/symptoms (including radiological). Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases.
Time frame: Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.
Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category
The percentage of participants with a Clinical Response as determined by the DRC at disease specific timepoints, by disease category. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) . Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms.
Time frame: Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen
The percentage of participants with a Clinical Response as determined by the DRC by disease category and by pathogen isolated, at disease specific timepoints. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) . Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms.
Time frame: Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease
The percentage of participants with a Clinical Response as determined by the DRC by fungal disease, at disease specific timepoints. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) . Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms.
Time frame: Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.
Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category
The percentage of participants with a Clinical Response as determined by the DRC by enrollment category, at disease specific timepoints. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) . Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms.
Time frame: Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.
Percentage of Participants With a Mycological Response by Disease Category
The percentage of participants with a Mycological Response as determined by the DRC by disease category, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker. Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection.
Time frame: Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.
Percentage of Participants With a Mycological Response by Disease Category and Pathogen
The percentage of participants with a Mycological Response as determined by the DRC by disease category and by pathogen, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker. Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection.
Time frame: Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.
Percentage of Participants With a Mycological Response by Fungal Disease
The percentage of participants with a Mycological Response as determined by the DRC by fungal disease, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker. Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection.
Time frame: Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.
Percentage of Participants With a Mycological Response by Enrollment Category
The percentage of participants with a Mycological Response as determined by the DRC by enrollment category, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker. Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection.
Time frame: Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.
Percentage of Participants With a Recurrence of Baseline Fungal Disease
The percentage of participants with a recurrence of their baseline fungal disease as assessed by the DRC at the 25-Day Follow Up (FU) for Vulvovaginal Candidiasis and at the 6-Week FU for all other diseases as assessed by the DRC. Recurrence is defined as having Global Response at end of treatment or test of cure, but re-emergence of the baseline fungal disease during the post treatment follow-up. Re-emergence is required to be with the same species and involving the same site identified at baseline.
Time frame: 42 days for vulvovaginal candidiasis and 6 weeks after End of Treatment (up to 180 days after treatment start) for all other diseases.
Percentage of Participants Surviving at Day 30 or Day 42
Percentage of participants with invasive candidiasis surviving at Day 30 post-Baseline or percentage of participants with other fungal diseases surviving at Day 42 post-Baseline.
Time frame: Day 30 post-Baseline for Invasive Candidiasis and Day 42 post-Baseline for all other fungal diseases.
Time to Death From Any Cause
Time to death from any cause in days per Fungal Disease
Time frame: Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.
Describe Ibrexafungerp Plasma Concentrations
Ibrexafungerp plasma concentrations measured at specified timepoints prior to and after administration of study drug for participants that received the following dose regimen: Day 1 and 2 loading dose - 750mg BID Day 3 onwards - 750mg QD
Time frame: Day 2 post-dose, Day 3-5 pre-dose, Dat 7-10 pre-dose.
| Milestone | Ibrexafungerp (SCY-078) |
|---|---|
| Started | 233 |
| Completed | 124 |
| Not completed | 109 |
The percentage of participants who achieve Global Response (defined as complete or partial response) as determined by the DRC at disease specific timepoints by fungal disease. Global Response is measured by participant survival and overall effect of treatment on the disease. Complete response: Survival, all attributable signs/symptoms (including radiological) resolved and myoclogical eradication of disease; Partial response: Survival, improvement of attributable signs/symptoms (including radiological). Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases.
| Participants | Ibrexafungerp (SCY-078) |
|---|---|
| Overall Study (ITT) — Success | 142 |
| Overall Study (ITT) — Failure | 69 |
| Overall Study (ITT) — Not Evaluable | 22 |
| Overall Study (PP) — Success | 131 |
| Overall Study (PP) — Failure | 59 |
| Overall Study (PP) — Not Evaluable | 5 |
| Acute Invasive Candidiasis including Candidemia (ITT) — Success | 40 |
| Acute Invasive Candidiasis including Candidemia (ITT) — Failure | 13 |
| Acute Invasive Candidiasis including Candidemia (ITT) — Not Evaluable | 8 |
| Acute Invasive Candidiasis including Candidemia (PP) — Success | 37 |
| Acute Invasive Candidiasis including Candidemia (PP) — Failure | 10 |
| Acute Invasive Candidiasis including Candidemia (PP) — Not Evaluable | 2 |
| Chronic Invasive Candidiasis (ITT) — Success | 30 |
| Chronic Invasive Candidiasis (ITT) — Failure | 9 |
| Chronic Invasive Candidiasis (ITT) — Not Evaluable | 4 |
| Chronic Invasive Candidiasis (PP) — Success | 25 |
| Chronic Invasive Candidiasis (PP) — Failure | 7 |
| Chronic Invasive Candidiasis (PP) — Not Evaluable | 1 |
| Esophageal Candidiasis (ITT) — Success | 9 |
| Esophageal Candidiasis (ITT) — Failure | 5 |
| Esophageal Candidiasis (ITT) — Not Evaluable | 2 |
| Esophageal Candidiasis (PP) — Success | 9 |
| Esophageal Candidiasis (PP) — Failure | 4 |
| Esophageal Candidiasis (PP) — Not Evaluable | 1 |
| Oropharyngeal Candidiasis (ITT) — Success | 9 |
| Oropharyngeal Candidiasis (ITT) — Failure | 5 |
| Oropharyngeal Candidiasis (ITT) — Not Evaluable | 0 |
| Oropharyngeal Candidiasis (PP) — Success | 8 |
| Oropharyngeal Candidiasis (PP) — Failure | 5 |
| Oropharyngeal Candidiasis (PP) — Not Evaluable | 0 |
| Chronic Mucocutaneous Candidiasis (ITT) — Success | 8 |
| Chronic Mucocutaneous Candidiasis (ITT) — Failure | 5 |
| Chronic Mucocutaneous Candidiasis (ITT) — Not Evaluable | 0 |
| Chronic Mucocutaneous Candidiasis (PP) — Success | 8 |
| Chronic Mucocutaneous Candidiasis (PP) — Failure | 4 |
| Chronic Mucocutaneous Candidiasis (PP) — Not Evaluable | 0 |
| Vulvovaginal Candidiasis (ITT) — Success | 26 |
| Vulvovaginal Candidiasis (ITT) — Failure | 4 |
| Vulvovaginal Candidiasis (ITT) — Not Evaluable | 2 |
| Vulvovaginal Candidiasis (PP) — Success | 24 |
| Vulvovaginal Candidiasis (PP) — Failure | 3 |
| Vulvovaginal Candidiasis (PP) — Not Evaluable | 0 |
| Disseminated/Invasive Dimorphic Fungi (ITT) — Success | 1 |
| Disseminated/Invasive Dimorphic Fungi (ITT) — Failure | 2 |
| Disseminated/Invasive Dimorphic Fungi (ITT) — Not Evaluable | 0 |
| Disseminated/Invasive Dimorphic Fungi (PP) — Success | 1 |
| Disseminated/Invasive Dimorphic Fungi (PP) — Failure | 2 |
| Disseminated/Invasive Dimorphic Fungi (PP) — Not Evaluable | 0 |
| Chronic Pulmonary Aspergillosis (ITT) — Success | 0 |
| Chronic Pulmonary Aspergillosis (ITT) — Failure | 6 |
| Chronic Pulmonary Aspergillosis (ITT) — Not Evaluable | 0 |
| Chronic Pulmonary Aspergillosis (PP) — Success | 0 |
| Chronic Pulmonary Aspergillosis (PP) — Failure | 5 |
| Chronic Pulmonary Aspergillosis (PP) — Not Evaluable | 0 |
| Allergic Bronchopulmonary Aspergillosis (ITT) — Success | 0 |
| Allergic Bronchopulmonary Aspergillosis (ITT) — Failure | 3 |
| Allergic Bronchopulmonary Aspergillosis (ITT) — Not Evaluable | 2 |
| Allergic Bronchopulmonary Aspergillosis (PP) — Success | 0 |
| Allergic Bronchopulmonary Aspergillosis (PP) — Failure | 3 |
| Allergic Bronchopulmonary Aspergillosis (PP) — Not Evaluable | 0 |
| Invasive Pulmonary Aspergillosis (ITT) — Success | 12 |
| Invasive Pulmonary Aspergillosis (ITT) — Failure | 14 |
| Invasive Pulmonary Aspergillosis (ITT) — Not Evaluable | 3 |
| Invasive Pulmonary Aspergillosis (PP) — Success | 12 |
| Invasive Pulmonary Aspergillosis (PP) — Failure | 13 |
| Invasive Pulmonary Aspergillosis (PP) — Not Evaluable | 1 |
| Other Emerging Fungi (ITT) — Success | 7 |
| Other Emerging Fungi (ITT) — Failure | 3 |
| Other Emerging Fungi (ITT) — Not Evaluable | 1 |
| Other Emerging Fungi (PP) — Success | 7 |
| Other Emerging Fungi (PP) — Failure | 3 |
| Other Emerging Fungi (PP) — Not Evaluable | 0 |
The percentage of participants who achieve a Global Response (defined as complete or partial response) as determined by the DRC by enrollment category, at disease specific timepoints. Global Response is measured by participant survival and overall effect of treatment on the disease. Complete response: Survival, all attributable signs/symptoms (including radiological) resolved and myoclogical eradication of disease; Partial response: Survival, improvement of attributable signs/symptoms (including radiological). Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Participants may have been enrolled for more than 1 enrollment reason.
| Participants | Ibrexafungerp (SCY-078) |
|---|---|
| Refractory Fungal Infection — Success | 74 |
| Refractory Fungal Infection — Failure | 41 |
| Refractory Fungal Infection — Not Evaluable | 13 |
| Resistance to standard of care antifungal — Success | 95 |
| Resistance to standard of care antifungal — Failure | 29 |
| Resistance to standard of care antifungal — Not Evaluable | 10 |
| Intolerance to standard of care antifungal — Success | 13 |
| Intolerance to standard of care antifungal — Failure | 14 |
| Intolerance to standard of care antifungal — Not Evaluable | 2 |
| Toxicities associated with standard of care antifungal — Success | 7 |
| Toxicities associated with standard of care antifungal — Failure | 8 |
| Toxicities associated with standard of care antifungal — Not Evaluable | 2 |
| Relapse — Success | 12 |
| Relapse — Failure | 5 |
| Relapse — Not Evaluable | 1 |
| Other — Success | 0 |
| Other — Failure | 1 |
| Other — Not Evaluable | 1 |
The percentage of participants who achieve Global Response (defined as complete or partial response) as determined by the DRC at disease specific timepoints by disease category. Global Response is measured by participant survival and overall effect of treatment on the disease. Complete response: Survival, all attributable signs/symptoms (including radiological) resolved and myoclogical eradication of disease; Partial response: Survival, improvement of attributable signs/symptoms (including radiological). Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases.
| Participants | Ibrexafungerp (SCY-078) |
|---|---|
| Invasive Candidiasis including Candidemia — Success | 70 |
| Invasive Candidiasis including Candidemia — Failure | 22 |
| Invasive Candidiasis including Candidemia — Not Evaluable | 12 |
| Mucocutaneous Candidiasis — Success | 52 |
| Mucocutaneous Candidiasis — Failure | 19 |
| Mucocutaneous Candidiasis — Not Evaluable | 4 |
| Dimorphic Fungi — Success | 1 |
| Dimorphic Fungi — Failure | 2 |
| Dimorphic Fungi — Not Evaluable | 0 |
| Aspergillus Syndromes — Success | 12 |
| Aspergillus Syndromes — Failure | 23 |
| Aspergillus Syndromes — Not Evaluable | 5 |
| Other emerging fungi — Success | 7 |
| Other emerging fungi — Failure | 3 |
| Other emerging fungi — Not Evaluable | 1 |
The percentage of participants with a Clinical Response as determined by the DRC at disease specific timepoints, by disease category. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) . Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms.
| Participants | Ibrexafungerp (SCY-078) |
|---|---|
| Invasive Candidiasis including Candidemia — Success | 57 |
| Invasive Candidiasis including Candidemia — Failure | 16 |
| Invasive Candidiasis including Candidemia — Not Evaluable | 29 |
| Invasive Candidiasis including Candidemia — No Response | 2 |
| Mucocutaneous Candidiasis (TOC) — Success | 25 |
| Mucocutaneous Candidiasis (TOC) — Failure | 5 |
| Mucocutaneous Candidiasis (TOC) — Not Evaluable | 2 |
| Mucocutaneous Candidiasis (TOC) — No Response | 43 |
| Dimorphic Fungi — Success | 3 |
| Dimorphic Fungi — Failure | 0 |
| Dimorphic Fungi — Not Evaluable | 0 |
| Dimorphic Fungi — No Response | 0 |
| Aspergillus Syndromes — Success | 18 |
| Aspergillus Syndromes — Failure | 14 |
| Aspergillus Syndromes — Not Evaluable | 6 |
| Aspergillus Syndromes — No Response | 2 |
| Other emerging fungi — Success | 7 |
| Other emerging fungi — Failure | 3 |
| Other emerging fungi — Not Evaluable | 1 |
| Other emerging fungi — No Response | 0 |
The percentage of participants with a Clinical Response as determined by the DRC by disease category and by pathogen isolated, at disease specific timepoints. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) . Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms.
| Participants | Ibrexafungerp (SCY-078) |
|---|---|
| Invasive Candidiasis, including Candidemia (C. albicans) — Success | 11 |
| Invasive Candidiasis, including Candidemia (C. albicans) — Failure | 7 |
| Invasive Candidiasis, including Candidemia (C. albicans) — Not Evaluable/Missing | 8 |
| Invasive Candidiasis, including Candidemia (C. auris) — Success | 6 |
| Invasive Candidiasis, including Candidemia (C. auris) — Failure | 1 |
| Invasive Candidiasis, including Candidemia (C. auris) — Not Evaluable/Missing | 3 |
| Invasive Candidiasis, including Candidemia (C. glabrata) — Success | 30 |
| Invasive Candidiasis, including Candidemia (C. glabrata) — Failure | 6 |
| Invasive Candidiasis, including Candidemia (C. glabrata) — Not Evaluable/Missing | 13 |
| Invasive Candidiasis, including Candidemia (C. krusei) — Success | 4 |
| Invasive Candidiasis, including Candidemia (C. krusei) — Failure | 2 |
| Invasive Candidiasis, including Candidemia (C. krusei) — Not Evaluable/Missing | 2 |
| Invasive Candidiasis, including Candidemia (C. parapsilosis) — Success | 5 |
| Invasive Candidiasis, including Candidemia (C. parapsilosis) — Failure | 1 |
| Invasive Candidiasis, including Candidemia (C. parapsilosis) — Not Evaluable/Missing | 3 |
| Invasive Candidiasis, including Candidemia (C. tropicalis) — Success | 6 |
| Invasive Candidiasis, including Candidemia (C. tropicalis) — Failure | 0 |
| Invasive Candidiasis, including Candidemia (C. tropicalis) — Not Evaluable/Missing | 3 |
| Invasive Candidiasis, including Candidemia (other) — Success | 3 |
| Invasive Candidiasis, including Candidemia (other) — Failure | 0 |
| Invasive Candidiasis, including Candidemia (other) — Not Evaluable/Missing | 2 |
| Mucocutaneous Candidiasis (C. albicans) — Success | 19 |
| Mucocutaneous Candidiasis (C. albicans) — Failure | 1 |
| Mucocutaneous Candidiasis (C. albicans) — Not Evaluable/Missing | 27 |
| Mucocutaneous Candidiasis (C. glabrata) — Success | 5 |
| Mucocutaneous Candidiasis (C. glabrata) — Failure | 3 |
| Mucocutaneous Candidiasis (C. glabrata) — Not Evaluable/Missing | 17 |
| Mucocutaneous Candidiasis (C. krusei) — Success | 2 |
| Mucocutaneous Candidiasis (C. krusei) — Failure | 1 |
| Mucocutaneous Candidiasis (C. krusei) — Not Evaluable/Missing | 4 |
| Mucocutaneous Candidiasis (C. tropicalis) — Success | 0 |
| Mucocutaneous Candidiasis (C. tropicalis) — Failure | 0 |
| Mucocutaneous Candidiasis (C. tropicalis) — Not Evaluable/Missing | 1 |
| Mucocutaneous Candidiasis (C. parapsilosis) — Success | 1 |
| Mucocutaneous Candidiasis (C. parapsilosis) — Failure | 0 |
| Mucocutaneous Candidiasis (C. parapsilosis) — Not Evaluable/Missing | 0 |
| Mucocutaneous Candidiasis (other) — Success | 3 |
| Mucocutaneous Candidiasis (other) — Failure | 1 |
| Mucocutaneous Candidiasis (other) — Not Evaluable/Missing | 5 |
| Dimorphic Fungi (Histoplasmosis) — Success | 3 |
| Dimorphic Fungi (Histoplasmosis) — Failure | 0 |
| Dimorphic Fungi (Histoplasmosis) — Not Evaluable/Missing | 0 |
| Aspergillus Syndromes (A. flavus) — Success | 2 |
| Aspergillus Syndromes (A. flavus) — Failure | 0 |
| Aspergillus Syndromes (A. flavus) — Not Evaluable/Missing | 0 |
| Aspergillus Syndromes (A. fumigatus) — Success | 8 |
| Aspergillus Syndromes (A. fumigatus) — Failure | 8 |
| Aspergillus Syndromes (A. fumigatus) — Not Evaluable/Missing | 2 |
| Aspergillus Syndromes (other) — Success | 9 |
| Aspergillus Syndromes (other) — Failure | 5 |
| Aspergillus Syndromes (other) — Not Evaluable/Missing | 0 |
The percentage of participants with a Clinical Response as determined by the DRC by fungal disease, at disease specific timepoints. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) . Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms.
| Participants | Ibrexafungerp (SCY-078) |
|---|---|
| Acute Invasive Candidiasis, including Candidemia — Success | 30 |
| Acute Invasive Candidiasis, including Candidemia — Failure | 10 |
| Acute Invasive Candidiasis, including Candidemia — Not Evaluable | 19 |
| Acute Invasive Candidiasis, including Candidemia — No Response | 2 |
| Chronic Invasive Candidiasis — Success | 27 |
| Chronic Invasive Candidiasis — Failure | 6 |
| Chronic Invasive Candidiasis — Not Evaluable | 10 |
| Chronic Invasive Candidiasis — No Response | 0 |
| Vulvovaginal Candidiasis — Success | 25 |
| Vulvovaginal Candidiasis — Failure | 5 |
| Vulvovaginal Candidiasis — Not Evaluable | 2 |
| Vulvovaginal Candidiasis — No Response | 0 |
| Esophageal Candidiasis — Success | 10 |
| Esophageal Candidiasis — Failure | 4 |
| Esophageal Candidiasis — Not Evaluable | 2 |
| Esophageal Candidiasis — No Response | 0 |
| Oropharyngeal Candidiasis — Success | 10 |
| Oropharyngeal Candidiasis — Failure | 4 |
| Oropharyngeal Candidiasis — Not Evaluable | 0 |
| Oropharyngeal Candidiasis — No Response | 0 |
| Chronic Mucocutaneous Candidiasis — Success | 8 |
| Chronic Mucocutaneous Candidiasis — Failure | 5 |
| Chronic Mucocutaneous Candidiasis — Not Evaluable | 0 |
| Chronic Mucocutaneous Candidiasis — No Response | 0 |
| Disseminated/Invasive Dimorphic Fungi — Success | 3 |
| Disseminated/Invasive Dimorphic Fungi — Failure | 0 |
| Disseminated/Invasive Dimorphic Fungi — Not Evaluable | 0 |
| Disseminated/Invasive Dimorphic Fungi — No Response | 0 |
| Chronic Pulmonary Aspergillosis — Success | 3 |
| Chronic Pulmonary Aspergillosis — Failure | 2 |
| Chronic Pulmonary Aspergillosis — Not Evaluable | 1 |
| Chronic Pulmonary Aspergillosis — No Response | 0 |
| Allergic Bronchopulmonary Aspergillosis — Success | 0 |
| Allergic Bronchopulmonary Aspergillosis — Failure | 2 |
| Allergic Bronchopulmonary Aspergillosis — Not Evaluable | 2 |
| Allergic Bronchopulmonary Aspergillosis — No Response | 1 |
| Invasive Pulmonary Aspergillosis — Success | 15 |
| Invasive Pulmonary Aspergillosis — Failure | 10 |
| Invasive Pulmonary Aspergillosis — Not Evaluable | 3 |
| Invasive Pulmonary Aspergillosis — No Response | 1 |
| Other Emerging Fungi — Success | 7 |
| Other Emerging Fungi — Failure | 3 |
| Other Emerging Fungi — Not Evaluable | 1 |
| Other Emerging Fungi — No Response | 0 |
The percentage of participants with a Clinical Response as determined by the DRC by enrollment category, at disease specific timepoints. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) . Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms.
| Participants | Ibrexafungerp (SCY-078) |
|---|---|
| Refractory — Success | 57 |
| Refractory — Failure | 29 |
| Refractory — Not Evaluable | 13 |
| Refractory — No Response | 29 |
| Resistence — Success | 75 |
| Resistence — Failure | 23 |
| Resistence — Not Evaluable | 25 |
| Resistence — No Response | 11 |
| Intolerance — Success | 16 |
| Intolerance — Failure | 8 |
| Intolerance — Not Evaluable | 3 |
| Intolerance — No Response | 2 |
| Toxicities — Success | 12 |
| Toxicities — Failure | 3 |
| Toxicities — Not Evaluable | 1 |
| Toxicities — No Response | 1 |
| Relapse — Success | 8 |
| Relapse — Failure | 4 |
| Relapse — Not Evaluable | 1 |
| Relapse — No Response | 5 |
The percentage of participants with a Mycological Response as determined by the DRC by disease category, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker. Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection.
| Participants | Ibrexafungerp (SCY-078) |
|---|---|
| Invasive Candidiasis including Candidemia — Success | 20 |
| Invasive Candidiasis including Candidemia — Failure | 14 |
| Invasive Candidiasis including Candidemia — Not Evaluable/Missing | 70 |
| Mucocutaneous Candidiasis (TOC) — Success | 11 |
| Mucocutaneous Candidiasis (TOC) — Failure | 13 |
| Mucocutaneous Candidiasis (TOC) — Not Evaluable/Missing | 51 |
| Dimorphic Fungi — Success | 0 |
| Dimorphic Fungi — Failure | 1 |
| Dimorphic Fungi — Not Evaluable/Missing | 2 |
| Aspergillus Syndromes — Success | 5 |
| Aspergillus Syndromes — Failure | 13 |
| Aspergillus Syndromes — Not Evaluable/Missing | 22 |
| Other emerging fungi — Success | 2 |
| Other emerging fungi — Failure | 2 |
| Other emerging fungi — Not Evaluable/Missing | 7 |
The percentage of participants with a Mycological Response as determined by the DRC by disease category and by pathogen, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker. Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection.
| Participants | Ibrexafungerp (SCY-078) |
|---|---|
| Invasive Candidiasis, including Candidemia (C. albicans) — Success | 3 |
| Invasive Candidiasis, including Candidemia (C. albicans) — Failure | 6 |
| Invasive Candidiasis, including Candidemia (C. albicans) — Not Evaluable/Missing | 17 |
| Invasive Candidiasis, including Candidemia (C. parapsilosis) — Success | 1 |
| Invasive Candidiasis, including Candidemia (C. parapsilosis) — Failure | 2 |
| Invasive Candidiasis, including Candidemia (C. parapsilosis) — Not Evaluable/Missing | 6 |
| Invasive Candidiasis, including Candidemia (C. auris) — Success | 2 |
| Invasive Candidiasis, including Candidemia (C. auris) — Failure | 1 |
| Invasive Candidiasis, including Candidemia (C. auris) — Not Evaluable/Missing | 7 |
| Invasive Candidiasis, including Candidemia (C. glabrata) — Success | 10 |
| Invasive Candidiasis, including Candidemia (C. glabrata) — Failure | 7 |
| Invasive Candidiasis, including Candidemia (C. glabrata) — Not Evaluable/Missing | 32 |
| Invasive Candidiasis, including Candidemia (C. krusei) — Success | 5 |
| Invasive Candidiasis, including Candidemia (C. krusei) — Failure | 0 |
| Invasive Candidiasis, including Candidemia (C. krusei) — Not Evaluable/Missing | 3 |
| Invasive Candidiasis, including Candidemia (C. tropicalis) — Success | 2 |
| Invasive Candidiasis, including Candidemia (C. tropicalis) — Failure | 0 |
| Invasive Candidiasis, including Candidemia (C. tropicalis) — Not Evaluable/Missing | 7 |
| Invasive Candidiasis, including Candidemia (other) — Success | 0 |
| Invasive Candidiasis, including Candidemia (other) — Failure | 0 |
| Invasive Candidiasis, including Candidemia (other) — Not Evaluable/Missing | 5 |
| Mucocutaneous Candidiasis (C. albicans) — Success | 10 |
| Mucocutaneous Candidiasis (C. albicans) — Failure | 5 |
| Mucocutaneous Candidiasis (C. albicans) — Not Evaluable/Missing | 32 |
| Mucocutaneous Candidiasis (C. glabrata) — Success | 0 |
| Mucocutaneous Candidiasis (C. glabrata) — Failure | 8 |
| Mucocutaneous Candidiasis (C. glabrata) — Not Evaluable/Missing | 17 |
| Mucocutaneous Candidiasis (C. krusei) — Success | 2 |
| Mucocutaneous Candidiasis (C. krusei) — Failure | 1 |
| Mucocutaneous Candidiasis (C. krusei) — Not Evaluable/Missing | 4 |
| Mucocutaneous Candidiasis (C. parapsilosis) — Success | 0 |
| Mucocutaneous Candidiasis (C. parapsilosis) — Failure | 0 |
| Mucocutaneous Candidiasis (C. parapsilosis) — Not Evaluable/Missing | 1 |
| Mucocutaneous Candidiasis (C. tropicalis) — Success | 0 |
| Mucocutaneous Candidiasis (C. tropicalis) — Failure | 0 |
| Mucocutaneous Candidiasis (C. tropicalis) — Not Evaluable/Missing | 1 |
| Mucocutaneous Candidiasis other) — Success | 2 |
| Mucocutaneous Candidiasis other) — Failure | 2 |
| Mucocutaneous Candidiasis other) — Not Evaluable/Missing | 5 |
| Dimorphic Fungi (Coccidioidomycosis) — Success | 0 |
| Dimorphic Fungi (Coccidioidomycosis) — Failure | 0 |
| Dimorphic Fungi (Coccidioidomycosis) — Not Evaluable/Missing | 0 |
| Dimorphic Fungi (Histoplasmosis) — Success | 0 |
| Dimorphic Fungi (Histoplasmosis) — Failure | 1 |
| Dimorphic Fungi (Histoplasmosis) — Not Evaluable/Missing | 2 |
| Aspergillus Syndromes (A. nidulans) — Success | 0 |
| Aspergillus Syndromes (A. nidulans) — Failure | 1 |
| Aspergillus Syndromes (A. nidulans) — Not Evaluable/Missing | 0 |
| Aspergillus Syndromes (A. fumigatus) — Success | 1 |
| Aspergillus Syndromes (A. fumigatus) — Failure | 5 |
| Aspergillus Syndromes (A. fumigatus) — Not Evaluable/Missing | 12 |
| Aspergillus Syndromes (A. flavus) — Success | 1 |
| Aspergillus Syndromes (A. flavus) — Failure | 1 |
| Aspergillus Syndromes (A. flavus) — Not Evaluable/Missing | 0 |
| Aspergillus Syndromes (other) — Success | 2 |
| Aspergillus Syndromes (other) — Failure | 7 |
| Aspergillus Syndromes (other) — Not Evaluable/Missing | 5 |
The percentage of participants with a Mycological Response as determined by the DRC by fungal disease, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker. Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection.
| Participants | Ibrexafungerp (SCY-078) |
|---|---|
| Acute Invasive Candidiasis, including Candidemia — Success | 16 |
| Acute Invasive Candidiasis, including Candidemia — Failure | 10 |
| Acute Invasive Candidiasis, including Candidemia — Not Evaluable/Missing | 35 |
| Chronic Invasive Candidiasis — Success | 4 |
| Chronic Invasive Candidiasis — Failure | 4 |
| Chronic Invasive Candidiasis — Not Evaluable/Missing | 35 |
| Esophageal Candidiasis — Success | 2 |
| Esophageal Candidiasis — Failure | 5 |
| Esophageal Candidiasis — Not Evaluable/Missing | 9 |
| Oropharyngeal Candidiasis — Success | 7 |
| Oropharyngeal Candidiasis — Failure | 4 |
| Oropharyngeal Candidiasis — Not Evaluable/Missing | 3 |
| Chronic Mucocutaneous Candidiasis — Success | 6 |
| Chronic Mucocutaneous Candidiasis — Failure | 6 |
| Chronic Mucocutaneous Candidiasis — Not Evaluable/Missing | 1 |
| Vulvovaginal Candidiasis — Success | 11 |
| Vulvovaginal Candidiasis — Failure | 13 |
| Vulvovaginal Candidiasis — Not Evaluable/Missing | 8 |
| Disseminated/Invasive Dimorphic Fungi — Success | 0 |
| Disseminated/Invasive Dimorphic Fungi — Failure | 1 |
| Disseminated/Invasive Dimorphic Fungi — Not Evaluable/Missing | 2 |
| Chronic Pulmonary Aspergillosis — Success | 1 |
| Chronic Pulmonary Aspergillosis — Failure | 4 |
| Chronic Pulmonary Aspergillosis — Not Evaluable/Missing | 1 |
| Allergic Bronchopulmonary Aspergillosis — Success | 1 |
| Allergic Bronchopulmonary Aspergillosis — Failure | 2 |
| Allergic Bronchopulmonary Aspergillosis — Not Evaluable/Missing | 2 |
| Invasive Pulmonary Aspergillosis — Success | 3 |
| Invasive Pulmonary Aspergillosis — Failure | 7 |
| Invasive Pulmonary Aspergillosis — Not Evaluable/Missing | 19 |
| Other Emerging Fungi — Success | 2 |
| Other Emerging Fungi — Failure | 2 |
| Other Emerging Fungi — Not Evaluable/Missing | 7 |
The percentage of participants with a Mycological Response as determined by the DRC by enrollment category, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker. Disease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection.
| Participants | Ibrexafungerp (SCY-078) |
|---|---|
| Refractory — Success | 21 |
| Refractory — Failure | 33 |
| Refractory — Not Evaluable/Failure | 74 |
| Resistence — Success | 28 |
| Resistence — Failure | 19 |
| Resistence — Not Evaluable/Failure | 87 |
| Intolerance — Success | 7 |
| Intolerance — Failure | 10 |
| Intolerance — Not Evaluable/Failure | 12 |
| Toxicities — Success | 1 |
| Toxicities — Failure | 5 |
| Toxicities — Not Evaluable/Failure | 11 |
| Relapse — Success | 5 |
| Relapse — Failure | 2 |
| Relapse — Not Evaluable/Failure | 11 |
The percentage of participants with a recurrence of their baseline fungal disease as assessed by the DRC at the 25-Day Follow Up (FU) for Vulvovaginal Candidiasis and at the 6-Week FU for all other diseases as assessed by the DRC. Recurrence is defined as having Global Response at end of treatment or test of cure, but re-emergence of the baseline fungal disease during the post treatment follow-up. Re-emergence is required to be with the same species and involving the same site identified at baseline.
| Participants | Ibrexafungerp (SCY-078) |
|---|---|
| Acute Invasive Candidiasis including Candidemia — Recurrence | 0 |
| Acute Invasive Candidiasis including Candidemia — No Recurrence | 35 |
| Acute Invasive Candidiasis including Candidemia — Not Evaluable | 5 |
| Chronic Invasive Candidasis — Recurrence | 0 |
| Chronic Invasive Candidasis — No Recurrence | 29 |
| Chronic Invasive Candidasis — Not Evaluable | 1 |
| Candidemia only — Recurrence | 0 |
| Candidemia only — No Recurrence | 11 |
| Candidemia only — Not Evaluable | 2 |
| Esophageal Candidiasis — Recurrence | 3 |
| Esophageal Candidiasis — No Recurrence | 5 |
| Esophageal Candidiasis — Not Evaluable | 1 |
| Oropharyngeal Candidiasis — Recurrence | 2 |
| Oropharyngeal Candidiasis — No Recurrence | 7 |
| Oropharyngeal Candidiasis — Not Evaluable | 0 |
| Chronic Mucotaneous Candidiasis — Recurrence | 4 |
| Chronic Mucotaneous Candidiasis — No Recurrence | 2 |
| Chronic Mucotaneous Candidiasis — Not Evaluable | 1 |
| Vulvovaginal Candidiasis — Recurrence | 6 |
| Vulvovaginal Candidiasis — No Recurrence | 18 |
| Vulvovaginal Candidiasis — Not Evaluable | 4 |
| Disseminated/Invasive Dimorphic Fungi — Recurrence | 1 |
| Disseminated/Invasive Dimorphic Fungi — No Recurrence | 0 |
| Disseminated/Invasive Dimorphic Fungi — Not Evaluable | 0 |
| Chronic Pulmonary Aspergillosis — Recurrence | 0 |
| Chronic Pulmonary Aspergillosis — No Recurrence | 1 |
| Chronic Pulmonary Aspergillosis — Not Evaluable | 0 |
| Allergic Bronchopulmonary Aspergillosis — Recurrence | 0 |
| Allergic Bronchopulmonary Aspergillosis — No Recurrence | 0 |
| Allergic Bronchopulmonary Aspergillosis — Not Evaluable | 0 |
| Invasive Pulmonary Aspergillosis — Recurrence | 2 |
| Invasive Pulmonary Aspergillosis — No Recurrence | 10 |
| Invasive Pulmonary Aspergillosis — Not Evaluable | 0 |
| Other — Recurrence | 0 |
| Other — No Recurrence | 6 |
| Other — Not Evaluable | 1 |
Percentage of participants with invasive candidiasis surviving at Day 30 post-Baseline or percentage of participants with other fungal diseases surviving at Day 42 post-Baseline.
| Participants | Ibrexafungerp (SCY-078) |
|---|---|
| Acute Invasive Candidiasis — Alive | 39 |
| Acute Invasive Candidiasis — Dead | 1 |
| Acute Invasive Candidiasis — Unknown | 1 |
| Chronic Invasive Candidiasis — Alive | 43 |
| Chronic Invasive Candidiasis — Dead | 0 |
| Chronic Invasive Candidiasis — Unknown | 0 |
| Candidemia — Alive | 17 |
| Candidemia — Dead | 1 |
| Candidemia — Unknown | 2 |
| Esophageal Candidiasis — Alive | 15 |
| Esophageal Candidiasis — Dead | 0 |
| Esophageal Candidiasis — Unknown | 1 |
| Oropharyngeal Candidiasis — Alive | 14 |
| Oropharyngeal Candidiasis — Dead | 0 |
| Oropharyngeal Candidiasis — Unknown | 0 |
| Chronic Mucocutaneous Candidiasis — Alive | 13 |
| Chronic Mucocutaneous Candidiasis — Dead | 0 |
| Chronic Mucocutaneous Candidiasis — Unknown | 0 |
| Vulvovaginal Candidiasis — Alive | 32 |
| Vulvovaginal Candidiasis — Dead | 0 |
| Vulvovaginal Candidiasis — Unknown | 0 |
| Disseminated/Invasive Dimorphic Fungi — Alive | 3 |
| Disseminated/Invasive Dimorphic Fungi — Dead | 0 |
| Disseminated/Invasive Dimorphic Fungi — Unknown | 0 |
| Chronic Pulmonary Aspergillosis — Alive | 5 |
| Chronic Pulmonary Aspergillosis — Dead | 0 |
| Chronic Pulmonary Aspergillosis — Unknown | 1 |
| Allergic Bronchopulmonary Aspergillosis — Alive | 5 |
| Allergic Bronchopulmonary Aspergillosis — Dead | 0 |
| Allergic Bronchopulmonary Aspergillosis — Unknown | 0 |
| Invasive Pulmonary Aspergillosis — Alive | 22 |
| Invasive Pulmonary Aspergillosis — Dead | 6 |
| Invasive Pulmonary Aspergillosis — Unknown | 1 |
| Other Emerging Fungi — Alive | 10 |
| Other Emerging Fungi — Dead | 0 |
| Other Emerging Fungi — Unknown | 1 |
Time to death from any cause in days per Fungal Disease
| Number of days | Ibrexafungerp (SCY-078) |
|---|---|
| Acute Invasive Candidiasis | NA (NA to NA) |
| Candidemia | NA (NA to NA) |
| Chronic Invasive Candidiasis | NA (NA to NA) |
| Vulvovaginal Candidiasis | NA (NA to NA) |
| Esophageal Candidiasis | NA (NA to NA) |
| Oropharyngeal Candidiasis | NA (122 to NA) |
| Chronic Mucocutaneous Candidiasis | NA (NA to NA) |
| Diffuse/Invasive Dimorphic Fungi | NA (NA to NA) |
| Chronic Pulmonary Aspergillosis | NA (125 to NA) |
| Allergic Bronchopulmonary Aspergillosis | NA (NA to NA) |
| Invasive Pulmonary Aspergillosis | 282 (282 to NA) |
| Other Emerging Fungi | 270 (270 to NA) |
Ibrexafungerp plasma concentrations measured at specified timepoints prior to and after administration of study drug for participants that received the following dose regimen: Day 1 and 2 loading dose - 750mg BID Day 3 onwards - 750mg QD
| nanograms per milliliter (ng/mL) | Ibrexafungerp (SCY-078) |
|---|---|
| Day 2 post-dose | 479 (0 to 1790) |
| Day 3-5 pre-dose | 644 (9.21 to 1980) |
| Day 7-10 pre-dose | 571 (0 to 1810) |
Collected over Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ibrexafungerp (SCY-078) | 15/233 (6.4%) | 102/233 (43.8%) | 215/233 (92.3%) |
| Event | Ibrexafungerp (SCY-078) |
|---|---|
| Acute kidney injuryRenal and urinary disorders | 7/233 |
| DiarrhoeaGastrointestinal disorders | 6/233 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 6/233 |
| COVID-19Infections and infestations | 5/233 |
| SepsisInfections and infestations | 5/233 |
| Urinary tract infectionInfections and infestations | 5/233 |
| DehydrationMetabolism and nutrition disorders | 4/233 |
| PneumoniaInfections and infestations | 4/233 |
| Septic shockInfections and infestations | 4/233 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 3/233 |
| Event | Ibrexafungerp (SCY-078) |
|---|---|
| DiarrhoeaGastrointestinal disorders | 163/233 |
| NauseaGastrointestinal disorders | 111/233 |
| VomitingGastrointestinal disorders | 92/233 |
| HeadacheNervous system disorders | 38/233 |
| PyrexiaGeneral disorders | 31/233 |
| Abdominal PainGastrointestinal disorders | 26/233 |
| Urinary Tract InfectionInfections and infestations | 22/233 |
| FatigueGeneral disorders | 20/233 |
| Abdominal Pain UpperGastrointestinal disorders | 18/233 |
| DizzinessNervous system disorders | 17/233 |
| Age, Continuous(years) | Ibrexafungerp (SCY-078) |
|---|---|
| Mean | 53.6 ± 16.23 |
| Sex: Female, Male(Participants) | Ibrexafungerp (SCY-078) |
|---|---|
| Female | 128 |
| Male | 105 |
| Ethnicity (NIH/OMB)(Participants) | Ibrexafungerp (SCY-078) |
|---|---|
| Hispanic or Latino | 10 |
| Not Hispanic or Latino | 219 |
| Unknown or Not Reported | 4 |
| Race (NIH/OMB)(Participants) | Ibrexafungerp (SCY-078) |
|---|---|
| American Indian or Alaska Native | 3 |
| Asian | 16 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 29 |
| White | 180 |
| More than one race | 1 |
| Unknown or Not Reported | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Studies of the drug tested here: Ibrexafungerp
Scynexis, Inc.