A Phase 2 interventional study of CM-4620 Injectable Emulsion or CM-4620-IE and Placebo in Acute Pancreatitis and Systemic Inflammatory Response Syndrome, sponsored by CalciMedica, Inc.. Completed at 37 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by CalciMedica, Inc. · Phase 2, Interventional, and Treatment
Approximately 216 patients with acute pancreatitis and accompanying SIRS will be randomized at approximately 30 sites. Patients will be randomly assigned to either Auxora at one of three dose levels or one of three placebo volumes to maintain the double-blind. Study drug infusions will occur every 24 hours for three consecutive days for a total of three infusions. Patients will remain hospitalized as per standard of care and once discharged will be asked to complete a daily meal diary and return for a Day 30 safety assessment. It is recommended that patients randomized in the study should not be discharged from the hospital until solid food is tolerated, abdominal pain has resolved or been adequately controlled, and there is no clinical evidence of infection necessitating continued hospitalization.
This double blind, randomized, placebo-controlled study will evaluate the efficacy, safety, and tolerability of three different dose levels of Auxora in patients with acute pancreatitis and accompanying SIRS.
Approximately 216 patients will be randomized 1:1:1:1 into one of 4 groups using a computer generated randomization scheme accessed through an interactive voice/web response system (IXRS). Randomization will be first stratified by gender (male or female) and then by risk for organ failure in the gender subgroups (higher or lower). Higher risk for organ failure is defined by the presence of both an elevated hematocrit (HCT ≥44% for men or ≥40% for women) and hypoxemia (imputed PaO2/FiO2 ≤360). Lower risk for organ failure is defined by the absence of either or both an elevated hematocrit and hypoxemia. The PaO2/FiO2 will be determined using an arterial blood gas or imputed using pulse oximetry.
All patients will have received a Screening CECT of the abdomen/pancreas before being randomized into the study. CECTs performed as standard of care may be used as the Screening CECT but must have been performed in the 24 hours before Consent or after Consent and before Randomization.
The Start of First Infusion of Study Drug (SFISD) should occur within 8 hours of the patient or LAR providing informed consent. Patients randomized to Group 1 will receive 2.0 mg/kg of Auxora intravenously every 24 hours (±1 hour) for a total of three doses. Patients randomized to Group 2 will receive 1.0 mg/kg of Auxora intravenously every 24 hours (±1 hour) for a total of three doses. Patients randomized to Group 3 will receive 0.5 mg/kg of Auxora intravenously every 24 hours (±1 hour) for a total of three doses. Patients randomized to Group 4 will receive emulsion without any active pharmaceutical ingredient. Patients in Group 4 will receive one of three randomly assigned dose volumes, 1.25 mL/kg, 0.625 mL/kg, or 0.3125 mL/kg, which will be administered intravenously every 24 hours (±1 hour) for a total of three doses. The dosing will be based on actual body weight obtained at the time of hospitalization or screening for the study. As described in the pharmacy manual, the upper limit of the volume of Auxora and volume of Placebo that will be administered will be 156.25 mL. The sponsor, investigators and patients will be blinded to the assigned group. In the event of a medical emergency, investigators will be able to receive the treatment assignment if required to provide optimal care of the patient.
For all 4 groups, a study physician or appropriately trained delegate will perform assessments at screening, at the baseline assessment, immediately prior to the SFISD, and then every 24 hours until 240 hours after the SFISD, or until discharge if earlier. If patients remain hospitalized at Day 12, assessments will then be performed every 48 hours starting on Day 12 until Day 28, or until discharge if earlier. Patients discharged from the hospital before Day 25 will return at Day 30 (+5 days) to perform the Day 30 assessments. If patients are discharged on Days 25-29, the Day 30 assessments may be performed prior to discharge.
Patients will receive another CECT of the abdomen/pancreas at the Day 30 (±5 days) visit. All CECTs performed as standard of care after randomization and before the Day 30 CECT will also be captured. A blinded central reader will read the Screening, Day 30, and any standard of care CECTs obtained between randomization and the Day 30 visit.
Patients will complete the modified American Neurogastroenterology and Motility Society Gastrointestinal Cardinal Symptom Index Daily Diary (mGCSI-DD) worksheet at the baseline assessment, at 96 hours, 168hours, Day 14 and Day 21 (for patients who remain hospitalized on these days), on the day of discharge, and daily at bedtime after discharge until the Day 30 visit. Patients who are discharged on Days 25-29 will not complete the mGCSI worksheet after discharge.
It is recommended that all patients randomized in the study should receive care consistent with the 2018 American Gastroenterological Association (AGA) Institute Technical Review of the Initial Medical Management of Acute Pancreatitis. Patients should receive local standard of care (SOC) for the management of other medical conditions.
In patients with acute pancreatitis, the AGA strongly recommends early oral feeding (within 24 hours) rather than keeping the patient nil per mouth (Nil per Os, NPO). Patients randomized into the study, therefore, will be offered a low fat, ≥500-calorie solid meal at each mealtime after the infusion of the first dose of study drug if alert and not on mechanical ventilation, or if not NPO for a planned surgery/medical procedure, or if not NPO because of an acute medical condition. If the patient does not wish to eat the solid meal when offered or is unable to tolerate the solid meal, they should then be offered a liquid meal. The same approach should occur at each subsequent mealtime. When patients eat a solid meal, it should be recorded if they ate ≥50% of the meal and if they either vomited or experienced an increase in abdominal pain in the two hours after eating a meal.
It is also recommended that all patients randomized in the study should not be discharged from the hospital until solid food is tolerated, abdominal pain has resolved or been adequately controlled, and there is no clinical evidence of infection. Tolerating solid food is defined as eating ≥50% of a low fat, ≥500-calorie solid meal without an increase in abdominal pain or vomiting. If the patient is not tolerating either solid or liquid meals, tube feedings should be considered.
All protocol required laboratory testing, except biomarker and PK samples, will be performed at the local laboratory. Results from the biomarkers and PK blood samples collected as part of the protocol and being tested at a central lab will not be available to assist the PI or treating physician in managing the patient.
557 studies on the registry are indexed under Pancreatitis; 164 are open to participants now.
This study's enrollment of 216 is above the median of 100 across 349 interventional studies indexed under Pancreatitis.
Browse Pancreatitis studies →CalciMedica, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All of the following must be met for a patient to be randomized into the study:
The diagnosis of acute pancreatitis has been established by the presence of abdominal pain consistent with acute pancreatitis together with at least 1 of the following 2 criteria:
The diagnosis of SIRS has been established by the presence of at least two of the following four criteria:
At least one of the following criteria is also present:
Exclusion Criteria:
Patients with any of the following conditions or characteristics must be excluded from randomizing:
The patient has a known history of:
Current treatment with:
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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
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.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.
Drug: CM-4620 Injectable Emulsion or CM-4620-IE
administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.
Drug: CM-4620 Injectable Emulsion or CM-4620-IE
administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.
Drug: CM-4620 Injectable Emulsion or CM-4620-IE
patients randomized to placebo will receive one of three following volumes (1.25 mL/kg, 0.625 mL/kg, and 0.3125 mL/kg. although three volumes - all patients randomized to placebo will be analyzed together as one arm. administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.
Other: Placebo
Auxora is to be administered as an IV infusion and is supplied as a translucent, white to yellowish colored, sterile, non-pyrogenic emulsion containing 1.6 mg/mL of the active pharmaceutical ingredient CM4620. CM4620-IE is supplied as an 80 mL fill in a 100 mL, single-use glass vial. The drug product is formulated as an emulsion due to the low solubility of CM4620 in aqueous solution. CM4620-IE contains egg phospholipids, medium chain triglycerides, glycerin, edetate disodium salt dehydrate (EDTA), sodium hydroxide (as needed to adjust pH), and sterile water for injection.
Also known as: Auxora
Matching Placebo is to be administered as an IV infusion and is supplied as a translucent, white to yellowish, sterile, non-pyrogenic emulsion carrier containing no active pharmaceutical ingredient. Placebo is supplied as an 80 mL fill in a 100 mL single-use vial. Placebo contains the same ingredients as Auxora except that it does not contain CM4620.
Median Time to Solid Food Tolerance, With gMCP Modeling Analysis for Dose-response Relationship
Time to Solid Food Tolerance (TSFT): Number of hours from date/time of SFISD to date/time patient receives a solid meal that is tolerated, defined as eating \>/=50% of a low fat \>/= 500-calorie solid meal w/o increase in abdominal pain or vomiting within 2 hours of mealtime. If patient was discharged w/o tolerating solid food, the daily record of the modified ANMS Gastrointestinal Cardinal Symptom Index Daily Diary (mGCSI-DD) at or after hospital discharge was used to calculate TSFT. For these patients, TSFT date/time was considered to be 8am on the first of 3 consecutive days where the following criteria were met in mGCSI-DD: no vomiting, no or mild nausea, no or mild inability to finish a normal sized meal, no or mild abdominal pain. gMCP-Mod: Generalized Multiple Comparisons and Modeling--3 steps: 1) Hazard ratio (dose vs placebo) using stratified Cox regression w/ stratification by sex and hematocrit (high/low). 2) Multiple contrast test. 3) Find best-fit dose-response model.
Time frame: from start of first infusion of study drug (SFISD) through day 30
Percentage of Patients With New Onset Severe Respiratory Failure, With gMCP Modeling Analysis for Dose-response Relationship
Analysis of patients without respiratory failure at the time of randomization (defined as a P/F ratio ≤300 measured by an arterial blood gas or imputed from pulse oximetry) who later developed severe respiratory failure during the course of the study.
Time frame: from enrollment and through day 30
Incidence, Severity, and Duration of Organ Failure
The incidence, severity and duration of organ failure was defined by the development of severe respiratory failure or severe renal failure or severe cardiac failure. The proportion of patients who developed each type of organ failure, or multi-organ failure (more than 1 organ failure), was analyzed.
Time frame: from enrollment and through day 30
Solid Food Tolerance
Number (and percentage) of patients who tolerated solid food at 48hrs, 72hrs, and 96hrs from start of first infusion of study drug, as well as at time of first discharge from hospital
Time frame: from SFISD to 48 hours, 72 hours and 96 hours and at time of hospital discharge (up to 30 days after SFISD)
Time to Medically Indicated Discharge
The time (in hours) to medically indicated discharge, defined as the number of days from the SFISD to the first date of meeting the criteria below: * the patient tolerated solid food, as defined by the main analytical approach; and * abdominal pain was controlled or resolved, which was defined by a reduction in pain, as assessed by the PNRS scale, of ≥50% from the peak level in the first 24 hours and no use of opioids; and * no clinical evidence of an infection requiring continued hospitalization. Kaplan-Meier (K-M) estimates of median time to medically indicated discharge are shown.
Time frame: from start of first infusion of study drug through time of hospital discharge or through Day 30, whichever occurs first
Length of Stay in the Hospital
Number of days in the hospital during the first 30 Days of the Study from the SFISD (start of first infusion of study drug) while still alive, for any reason. Includes ICU stay and readmissions. The number of days in the hospital before the patient's death was used in the analysis.(Note: there was only 1 patient death in this study, in the 1.0 mg/kg Auxora group)
Time frame: from admission date into the hospital until discharge date from the hospital
Re-hospitalization for Acute Pancreatitis by Day 30
The proportion of patients who were re-hospitalized for either acute pancreatitis, or the development of pancreatic necrosis/necrotizing pancreatitis through the Day 30 visit.
Time frame: time from initial date of hospital discharge through date of re-hospitalization through day 30
Change in Severity of Acute Pancreatitis by CTSI Score From Screening to Day 30
Independent reviewers performed a blinded central review of Contrast Enhanced Computed Tomography (CECT) imaging data, or MRI imaging data, obtained at the Screening and Day 30 visits to assess the Computed Tomography Severity Index (CTSI). Review was performed by two independent radiologists (primary review) using a consensus methodology. The CTSI scoring uses a combination of Balthazar score grading of pancreatitis (A-E) and grading the extent of pancreatic necrosis (none, ≤30%, \>30-50%, or \>50%) to designate AP as mild, moderate, or severe. Proportion of patients with moderate or severe AP by CTSI score at baseline who became mild AP at Day 30, and the proportion of patients with mild AP by CTSI at baseline who had moderate or severe AP at Day 30 were analyzed.
Time frame: From informed consent through day 30
Development of Pancreatic Necrosis ≥30% and >50%
Development of pancreatic necrosis ≥30% and \>50% in patients who had no pancreatic necrosis at screening (Note: There were no patients with pancreatic necrosis at screening in any of the treatment groups.)
Time frame: from enrollment CECT through Day 30 CECT
The Persistence of SIRS ≥48 Hours After the SFISD
The proportion of patients who developed persistence of SIRS ≥48 Hours after the SFISD analyzed through Day 30. If the patient was discharged before 48 Hours after the SFISD, the last available post-treatment data was used to define the SIRS status at 48 hours after the SFISD based on the LOCF method.
Time frame: from SFISD through day 30
Mortality by Day 30
Mortality was assessed from randomization through Day 30
Time frame: from randomization and through day 30
Change in Pain Score
Mean change in Pain Numeric Rating Score (PNRS) from baseline (time of screening). In patients who were able to self-report their pain, the PNRS was used to grade the severity of the abdominal pain. Patients were asked, "On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable, how would you rate your pain RIGHT NOW." It was also recorded if an opioid analgesic had been given in the 2 hours prior to the PNRS determination.
Time frame: from enrollment through day 30
Win Ratio for Auxora vs. Placebo
The win ratio compares effectiveness of each Auxora dose group with the placebo group. It is calculated by dividing the total number of wins by the total number of losses, with a win ratio \>1 indicating better outcomes for Auxora treatment. Comparison between placebo and Auxora outcomes was performed in a hierarchical manner, in the following order: 1. Mortality (see Outcome Measure 11), 2. New Onset Severe Respiratory Failure (see Outcome Measure 2), 3. New Onset Necrotizing Pancreatitis at Day 30 (see Outcome Measure 18), and 4. Time to Medically Indicated Discharge (see Outcome Measure 5). Stratification was performed by sex (male or female) and then by HCT (higher or lower). Subjects with respiratory failure at baseline were imputed as a non-event. Subjects with missing necrotizing pancreatitis evaluation or positive necrotizing pancreatitis at screening were imputed as a non-event. Subjects missing a necrotizing pancreatitis evaluation at Day 30 were imputed as a non-event.
Time frame: from randomization through Day 30
Development of Infected Pancreatic Necrosis
Exploratory. Percentage of Patients with Infected Pancreatic Necrosis at Day 30 after SFISD.
Time frame: from end of first infusion of study drug through Day 30 CECT
Development of Sepsis
Exploratory. Count of patients who experienced sepsis after SFISD.
Time frame: from end of first infusion of study drug through day 30
Change in ANC/ALC Ratio and IL-6 Levels
Exploratory analysis of serum biomarkers.
Time frame: from randomization through day 30
Change in Urine NGAL
Exploratory analysis of urine biomarker NGAL
Time frame: from randomization through day 30
Number of Patients That Developed Any New Onset Necrotizing Pancreatitis by Day 30
The number of patients who had no necrotizing pancreatitis at screening, and developed any amount of necrotizing pancreatitis based on the Day 30 visit CECT reading results.
Time frame: From SFISD to Day 30
| Milestone | Auxora 2.0 mg/kg (1.25 mL/kg) | Auxora 1.0 mg/kg (0.625 mL/kg) | Auxora 0.5 mg/kg (0.3125 mL/kg) | Placebo (1.25, 0.625, or 0.3125 mL/kg) |
|---|---|---|---|---|
| Started | 54 | 56 | 53 | 53 |
| Completed | 49 | 53 | 51 | 49 |
| Not completed | 5 | 3 | 2 | 4 |
| Withdrew: Lost to follow-up | 3 | 1 | 2 | 1 |
| Withdrew: Withdrawal by subject | 2 | 1 | 0 | 3 |
| Withdrew: Death | 0 | 1 | 0 | 0 |
Time to Solid Food Tolerance (TSFT): Number of hours from date/time of SFISD to date/time patient receives a solid meal that is tolerated, defined as eating \>/=50% of a low fat \>/= 500-calorie solid meal w/o increase in abdominal pain or vomiting within 2 hours of mealtime. If patient was discharged w/o tolerating solid food, the daily record of the modified ANMS Gastrointestinal Cardinal Symptom Index Daily Diary (mGCSI-DD) at or after hospital discharge was used to calculate TSFT. For these patients, TSFT date/time was considered to be 8am on the first of 3 consecutive days where the following criteria were met in mGCSI-DD: no vomiting, no or mild nausea, no or mild inability to finish a normal sized meal, no or mild abdominal pain. gMCP-Mod: Generalized Multiple Comparisons and Modeling--3 steps: 1) Hazard ratio (dose vs placebo) using stratified Cox regression w/ stratification by sex and hematocrit (high/low). 2) Multiple contrast test. 3) Find best-fit dose-response model.
| Hours | Auxora 2.0 mg/kg (1.25 mL/kg) | Auxora 1.0 mg/kg (0.625 mL/kg) | Auxora 0.5 mg/kg (0.3125 mL/kg) | Placebo (1.25, 0.625, or 0.3125 mL/kg) |
|---|---|---|---|---|
| All Patients | 67.0 (39.0 to 91.0) | 64.0 (43.0 to 93.0) | 78.0 (39.0 to 118.0) | 66.0 (44.0 to 116.0) |
| High Hematocrit subgroup | 67.0 (26.0 to 95.0) | 64.0 (20.0 to 101.0) | 78.0 (37.0 to 167.0) | 113.5 (40.0 to 187.0) |
Analysis of patients without respiratory failure at the time of randomization (defined as a P/F ratio ≤300 measured by an arterial blood gas or imputed from pulse oximetry) who later developed severe respiratory failure during the course of the study.
| Participants | Auxora 2.0 mg/kg (1.25 mL/kg) | Auxora 1.0 mg/kg (0.625 mL/kg) | Auxora 0.5 mg/kg (0.3125 mL/kg) | Placebo (1.25, 0.625, or 0.3125 mL/kg) |
|---|---|---|---|---|
| Percentage of Patients With New Onset Severe Respiratory Failure, With gMCP Modeling Analysis for Dose-response Relationship | 0 | 0 | 4 | 4 |
The incidence, severity and duration of organ failure was defined by the development of severe respiratory failure or severe renal failure or severe cardiac failure. The proportion of patients who developed each type of organ failure, or multi-organ failure (more than 1 organ failure), was analyzed.
| Participants | Auxora 2.0 mg/kg (1.25 mL/kg) | Auxora 1.0 mg/kg (0.625 mL/kg) | Auxora 0.5 mg/kg (0.3125 mL/kg) | Placebo (1.25, 0.625, or 0.3125 mL/kg) |
|---|---|---|---|---|
| Any severe organ failure | 2 | 2 | 5 | 5 |
| Severe respiratory failure | 2 | 2 | 5 | 4 |
| Severe renal failure | 0 | 1 | 2 | 1 |
| Severe cardiac failure | 1 | 1 | 3 | 1 |
Number (and percentage) of patients who tolerated solid food at 48hrs, 72hrs, and 96hrs from start of first infusion of study drug, as well as at time of first discharge from hospital
| Participants | Auxora 2.0 mg/kg (1.25 mL/kg) | Auxora 1.0 mg/kg (0.625 mL/kg) | Auxora 0.5 mg/kg (0.3125 mL/kg) | Placebo (1.25, 0.625, or 0.3125 mL/kg) |
|---|---|---|---|---|
| 48hrs | 23 | 26 | 23 | 21 |
| 72hrs | 27 | 30 | 25 | 30 |
| 96hrs | 37 | 35 | 31 | 30 |
| Hospital Discharge | 44 | 41 | 39 | 42 |
The time (in hours) to medically indicated discharge, defined as the number of days from the SFISD to the first date of meeting the criteria below: * the patient tolerated solid food, as defined by the main analytical approach; and * abdominal pain was controlled or resolved, which was defined by a reduction in pain, as assessed by the PNRS scale, of ≥50% from the peak level in the first 24 hours and no use of opioids; and * no clinical evidence of an infection requiring continued hospitalization. Kaplan-Meier (K-M) estimates of median time to medically indicated discharge are shown.
| hours | Auxora 2.0 mg/kg (1.25 mL/kg) | Auxora 1.0 mg/kg (0.625 mL/kg) | Auxora 0.5 mg/kg (0.3125 mL/kg) | Placebo (1.25, 0.625, or 0.3125 mL/kg) |
|---|---|---|---|---|
| Time to Medically Indicated Discharge | 89 (48 to 118) | 104.5 (73 to 164) | 109.5 (82 to 164) | 104 (67 to 144) |
Number of days in the hospital during the first 30 Days of the Study from the SFISD (start of first infusion of study drug) while still alive, for any reason. Includes ICU stay and readmissions. The number of days in the hospital before the patient's death was used in the analysis.(Note: there was only 1 patient death in this study, in the 1.0 mg/kg Auxora group)
| days | Auxora 2.0 mg/kg (1.25 mL/kg) | Auxora 1.0 mg/kg (0.625 mL/kg) | Auxora 0.5 mg/kg (0.3125 mL/kg) | Placebo (1.25, 0.625, or 0.3125 mL/kg) |
|---|---|---|---|---|
| Length of Stay in the Hospital | 5.9 ± 3.77 | 5.9 ± 4.46 | 7.6 ± 6.54 | 7.1 ± 5.87 |
The proportion of patients who were re-hospitalized for either acute pancreatitis, or the development of pancreatic necrosis/necrotizing pancreatitis through the Day 30 visit.
| Participants | Auxora 2.0 mg/kg (1.25 mL/kg) | Auxora 1.0 mg/kg (0.625 mL/kg) | Auxora 0.5 mg/kg (0.3125 mL/kg) | Placebo (1.25, 0.625, or 0.3125 mL/kg) |
|---|---|---|---|---|
| All rehospitalizations due to AP | 4 | 3 | 1 | 0 |
| Cause of AP rehospitalization - alcohol | 2 | 2 | 0 | 0 |
| Cause of AP rehospitalization - biliary | 1 | 0 | 1 | 0 |
| Cause of AP rehospitalization - abdominal pain (from AP) | 1 | 0 | 0 | 0 |
| Cause of AP rehospitalization - hypertriglyceridemia | 0 | 1 | 0 | 0 |
Independent reviewers performed a blinded central review of Contrast Enhanced Computed Tomography (CECT) imaging data, or MRI imaging data, obtained at the Screening and Day 30 visits to assess the Computed Tomography Severity Index (CTSI). Review was performed by two independent radiologists (primary review) using a consensus methodology. The CTSI scoring uses a combination of Balthazar score grading of pancreatitis (A-E) and grading the extent of pancreatic necrosis (none, ≤30%, \>30-50%, or \>50%) to designate AP as mild, moderate, or severe. Proportion of patients with moderate or severe AP by CTSI score at baseline who became mild AP at Day 30, and the proportion of patients with mild AP by CTSI at baseline who had moderate or severe AP at Day 30 were analyzed.
| Participants | Auxora 2.0 mg/kg (1.25 mL/kg) | Auxora 1.0 mg/kg (0.625 mL/kg) | Auxora 0.5 mg/kg (0.3125 mL/kg) | Placebo (1.25, 0.625, or 0.3125 mL/kg) |
|---|---|---|---|---|
| Patients with Moderate or Severe AP at baseline who had Mild AP at Day 30 (by CTSI score) | 10 | 8 | 12 | 14 |
| Patients with Mild AP at baseline who had Moderate or Severe AP at Day 30 (by CTSI score) | 0 | 2 | 2 | 0 |
Development of pancreatic necrosis ≥30% and \>50% in patients who had no pancreatic necrosis at screening (Note: There were no patients with pancreatic necrosis at screening in any of the treatment groups.)
| Participants | Auxora 2.0 mg/kg (1.25 mL/kg) | Auxora 1.0 mg/kg (0.625 mL/kg) | Auxora 0.5 mg/kg (0.3125 mL/kg) | Placebo (1.25, 0.625, or 0.3125 mL/kg) |
|---|---|---|---|---|
| Pancreatic Necrosis >50% | 1 | 1 | 1 | 0 |
| Pancreatic Necrosis 30% to 50% | 0 | 0 | 1 | 0 |
The proportion of patients who developed persistence of SIRS ≥48 Hours after the SFISD analyzed through Day 30. If the patient was discharged before 48 Hours after the SFISD, the last available post-treatment data was used to define the SIRS status at 48 hours after the SFISD based on the LOCF method.
| Participants | Auxora 2.0 mg/kg (1.25 mL/kg) | Auxora 1.0 mg/kg (0.625 mL/kg) | Auxora 0.5 mg/kg (0.3125 mL/kg) | Placebo (1.25, 0.625, or 0.3125 mL/kg) |
|---|---|---|---|---|
| The Persistence of SIRS ≥48 Hours After the SFISD | 11 | 8 | 15 | 13 |
Mortality was assessed from randomization through Day 30
| Participants | Auxora 2.0 mg/kg (1.25 mL/kg) | Auxora 1.0 mg/kg (0.625 mL/kg) | Auxora 0.5 mg/kg (0.3125 mL/kg) | Placebo (1.25, 0.625, or 0.3125 mL/kg) |
|---|---|---|---|---|
| Mortality by Day 30 | 0 | 1 | 0 | 0 |
Mean change in Pain Numeric Rating Score (PNRS) from baseline (time of screening). In patients who were able to self-report their pain, the PNRS was used to grade the severity of the abdominal pain. Patients were asked, "On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable, how would you rate your pain RIGHT NOW." It was also recorded if an opioid analgesic had been given in the 2 hours prior to the PNRS determination.
| score on a scale | Auxora 2.0 mg/kg (1.25 mL/kg) | Auxora 1.0 mg/kg (0.625 mL/kg) | Auxora 0.5 mg/kg (0.3125 mL/kg) | Placebo (1.25, 0.625, or 0.3125 mL/kg) |
|---|---|---|---|---|
| Change from Baseline at 48hrs | -3.3 ± 3.33 | -3.2 ± 2.98 | -3.2 ± 3.22 | -3.1 ± 3.10 |
| Change from Baseline at 72hrs | -4.1 ± 3.49 | -3.8 ± 3.18 | -3.8 ± 3.71 | -3.7 ± 3.18 |
| Change from Baseline at 96hrs | -4.6 ± 3.26 | -4.5 ± 3.87 | -3.1 ± 3.21 | -3.6 ± 2.29 |
The win ratio compares effectiveness of each Auxora dose group with the placebo group. It is calculated by dividing the total number of wins by the total number of losses, with a win ratio \>1 indicating better outcomes for Auxora treatment. Comparison between placebo and Auxora outcomes was performed in a hierarchical manner, in the following order: 1. Mortality (see Outcome Measure 11), 2. New Onset Severe Respiratory Failure (see Outcome Measure 2), 3. New Onset Necrotizing Pancreatitis at Day 30 (see Outcome Measure 18), and 4. Time to Medically Indicated Discharge (see Outcome Measure 5). Stratification was performed by sex (male or female) and then by HCT (higher or lower). Subjects with respiratory failure at baseline were imputed as a non-event. Subjects with missing necrotizing pancreatitis evaluation or positive necrotizing pancreatitis at screening were imputed as a non-event. Subjects missing a necrotizing pancreatitis evaluation at Day 30 were imputed as a non-event.
| Win Ratio | Auxora 2.0 mg/kg (1.25 mL/kg) | Auxora 1.0 mg/kg (0.625 mL/kg) | Auxora 0.5 mg/kg (0.3125 mL/kg) |
|---|---|---|---|
| Stratified Win Ratio - ALL | 1.640 (1.030 to 2.612) | 1.177 (0.740 to 1.871) | 1.123 (0.708 to 1.781) |
| Stratified Win Ratio - High HCT | 1.507 (0.741 to 3.063) | 1.241 (0.586 to 2.627) | 1.200 (0.596 to 2.415) |
| Stratified Win Ratio - Balthazar D or E | 2.071 (1.135 to 3.779) | 1.501 (0.827 to 2.724) | 1.613 (0.922 to 2.824) |
Exploratory. Percentage of Patients with Infected Pancreatic Necrosis at Day 30 after SFISD.
| Participants | Auxora 2.0 mg/kg (1.25 mL/kg) | Auxora 1.0 mg/kg (0.625 mL/kg) | Auxora 0.5 mg/kg (0.3125 mL/kg) | Placebo (1.25, 0.625, or 0.3125 mL/kg) |
|---|---|---|---|---|
| Development of Infected Pancreatic Necrosis | 1 | 0 | 0 | 1 |
Exploratory. Count of patients who experienced sepsis after SFISD.
| Participants | Auxora 2.0 mg/kg (1.25 mL/kg) | Auxora 1.0 mg/kg (0.625 mL/kg) | Auxora 0.5 mg/kg (0.3125 mL/kg) | Placebo (1.25, 0.625, or 0.3125 mL/kg) |
|---|---|---|---|---|
| Development of Sepsis | 0 | 2 | 3 | 1 |
Exploratory analysis of serum biomarkers.
Results for this outcome have not been posted.
Exploratory analysis of urine biomarker NGAL
Results for this outcome have not been posted.
The number of patients who had no necrotizing pancreatitis at screening, and developed any amount of necrotizing pancreatitis based on the Day 30 visit CECT reading results.
| Participants | Auxora 2.0 mg/kg (1.25 mL/kg) | Auxora 1.0 mg/kg (0.625 mL/kg) | Auxora 0.5 mg/kg (0.3125 mL/kg) | Placebo (1.25, 0.625, or 0.3125 mL/kg) |
|---|---|---|---|---|
| Number of Patients That Developed Any New Onset Necrotizing Pancreatitis by Day 30 | 11 | 27 | 24 | 17 |
Collected over Patients were evaluated for adverse events daily, from randomization to their final visit. Documentation of each patient's adverse events continued until the patient died, the patient withdrew consent, or the patient's participation in the study ended. For patients who completed the study, the last AE assessment performed on Day 30 visit, which was scheduled 30 days after start of first infusion of study drug +/- 5 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Auxora 2.0 mg/kg (1.25 mL/kg) | 0/53 (0%) | 8/53 (15.1%) | 22/53 (41.5%) |
| Auxora 1.0 mg/kg (0.625 mL/kg) | 1/56 (1.8%) | 12/56 (21.4%) | 32/56 (57.1%) |
| Auxora 0.5 mg/kg (0.3125 mL/kg) | 0/52 (0%) | 13/52 (25%) | 26/52 (50%) |
| Placebo (1.25, 0.625, or 0.3125 mL/kg) | 0/53 (0%) | 6/53 (11.3%) | 23/53 (43.4%) |
| Event | Auxora 2.0 mg/kg (1.25 mL/kg) | Auxora 1.0 mg/kg (0.625 mL/kg) | Auxora 0.5 mg/kg (0.3125 mL/kg) | Placebo (1.25, 0.625, or 0.3125 mL/kg) |
|---|---|---|---|---|
| Pancreatitis acuteGastrointestinal disorders | 4/53 | 3/56 | 2/52 | 0/53 |
| Acute kidney injuryRenal and urinary disorders | 1/53 | 1/56 | 2/52 | 1/53 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/53 | 0/56 | 2/52 | 1/53 |
| Pancreatitis necrotisingGastrointestinal disorders | 0/53 | 2/56 | 1/52 | 2/53 |
| Cholecystitis acuteHepatobiliary disorders | 0/53 | 2/56 | 0/52 | 0/53 |
| IleusGastrointestinal disorders | 0/53 | 1/56 | 1/52 | 0/53 |
| HaematocheziaGastrointestinal disorders | 0/53 | 0/56 | 1/52 | 0/53 |
| Escherichia sepsisInfections and infestations | 0/53 | 0/56 | 1/52 | 0/53 |
| GastroenteritisInfections and infestations | 0/53 | 0/56 | 1/52 | 0/53 |
| Pneumonia aspirationInfections and infestations | 0/53 | 0/56 | 1/52 | 0/53 |
| Event | Auxora 2.0 mg/kg (1.25 mL/kg) | Auxora 1.0 mg/kg (0.625 mL/kg) | Auxora 0.5 mg/kg (0.3125 mL/kg) | Placebo (1.25, 0.625, or 0.3125 mL/kg) |
|---|---|---|---|---|
| ConstipationGastrointestinal disorders | 1/53 | 5/56 | 3/52 | 6/53 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 3/53 | 2/56 | 5/52 | 4/53 |
| HypokalaemiaMetabolism and nutrition disorders | 3/53 | 4/56 | 1/52 | 0/53 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/53 | 0/56 | 3/52 | 0/53 |
| PyrexiaGeneral disorders | 3/53 | 3/56 | 3/52 | 2/53 |
| InsomniaPsychiatric disorders | 0/53 | 0/56 | 3/52 | 0/53 |
| AnaemiaBlood and lymphatic system disorders | 3/53 | 3/56 | 2/52 | 2/53 |
| LeukocytosisBlood and lymphatic system disorders | 0/53 | 0/56 | 0/52 | 3/53 |
| DiarrhoeaGastrointestinal disorders | 3/53 | 3/56 | 2/52 | 3/53 |
| Abdominal painGastrointestinal disorders | 3/53 | 2/56 | 2/52 | 1/53 |
Two subjects were randomized but discharged before study drug could be administered. These two patients were excluded from all analysis.
| Age, Categorical(Participants) | Auxora 2.0 mg/kg (1.25 mL/kg) | Auxora 1.0 mg/kg (0.625 mL/kg) | Auxora 0.5 mg/kg (0.3125 mL/kg) | Placebo (1.25, 0.625, or 0.3125 mL/kg) | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 48 | 44 | 40 | 47 | 179 |
| >=65 years | 5 | 12 | 12 | 6 | 35 |
| Age, Continuous(years) | Auxora 2.0 mg/kg (1.25 mL/kg) | Auxora 1.0 mg/kg (0.625 mL/kg) | Auxora 0.5 mg/kg (0.3125 mL/kg) | Placebo (1.25, 0.625, or 0.3125 mL/kg) | Total |
|---|---|---|---|---|---|
| Mean | 43.58 ± 15.311 | 47.41 ± 16.876 | 49.23 ± 16.131 | 44.79 ± 15.181 | 46.26 ± 15.943 |
| Sex: Female, Male(Participants) | Auxora 2.0 mg/kg (1.25 mL/kg) | Auxora 1.0 mg/kg (0.625 mL/kg) | Auxora 0.5 mg/kg (0.3125 mL/kg) | Placebo (1.25, 0.625, or 0.3125 mL/kg) | Total |
|---|---|---|---|---|---|
| Female | 20 | 23 | 20 | 20 | 83 |
| Male | 33 | 33 | 32 | 33 | 131 |
| Ethnicity (NIH/OMB)(Participants) | Auxora 2.0 mg/kg (1.25 mL/kg) | Auxora 1.0 mg/kg (0.625 mL/kg) | Auxora 0.5 mg/kg (0.3125 mL/kg) | Placebo (1.25, 0.625, or 0.3125 mL/kg) | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 10 | 8 | 14 | 13 | 45 |
| Not Hispanic or Latino | 42 | 46 | 38 | 39 | 165 |
| Unknown or Not Reported | 1 | 2 | 0 | 1 | 4 |
| Race (NIH/OMB)(Participants) | Auxora 2.0 mg/kg (1.25 mL/kg) | Auxora 1.0 mg/kg (0.625 mL/kg) | Auxora 0.5 mg/kg (0.3125 mL/kg) | Placebo (1.25, 0.625, or 0.3125 mL/kg) | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 1 | 1 |
| Asian | 16 | 17 | 16 | 20 | 69 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 1 | 1 |
| Black or African American | 13 | 10 | 8 | 8 | 39 |
| White | 21 | 26 | 22 | 15 | 84 |
| More than one race | 3 | 3 | 6 | 8 | 20 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Auxora 2.0 mg/kg (1.25 mL/kg) | Auxora 1.0 mg/kg (0.625 mL/kg) | Auxora 0.5 mg/kg (0.3125 mL/kg) | Placebo (1.25, 0.625, or 0.3125 mL/kg) | Total |
|---|---|---|---|---|---|
| United States | 37 | 40 | 37 | 36 | 150 |
| India | 16 | 16 | 15 | 17 | 64 |
| Etiology(Participants) | Auxora 2.0 mg/kg (1.25 mL/kg) | Auxora 1.0 mg/kg (0.625 mL/kg) | Auxora 0.5 mg/kg (0.3125 mL/kg) | Placebo (1.25, 0.625, or 0.3125 mL/kg) | Total |
|---|---|---|---|---|---|
| Alcohol | 26 | 25 | 22 | 18 | 91 |
| Biliary | 8 | 11 | 10 | 14 | 43 |
| Drug Induced | 1 | 1 | 0 | 0 | 2 |
| Hypertriglyceridemia | 4 | 4 | 5 | 9 | 22 |
| Surgery/Trauma | 0 | 0 | 1 | 0 | 1 |
| Other | 4 | 4 | 4 | 4 | 16 |
| Unknown | 10 | 11 | 10 | 8 | 39 |
| High Hematocrit (>/= 44 males; >/= 40 females)(Participants) | Auxora 2.0 mg/kg (1.25 mL/kg) | Auxora 1.0 mg/kg (0.625 mL/kg) | Auxora 0.5 mg/kg (0.3125 mL/kg) | Placebo (1.25, 0.625, or 0.3125 mL/kg) | Total |
|---|---|---|---|---|---|
| Count of participants | 23 | 25 | 24 | 20 | 92 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Zegocractin
CalciMedica, Inc.