A Phase 4 interventional study of Sovateltide and Normal Saline in Acute Cerebral Ischemia, sponsored by Pharmazz, Inc.. Recruiting at 6 sites in India. Open to participants aged 18 Years to 78 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Pharmazz, Inc. · Phase 4, Interventional, and Treatment
This is a prospective, multicenter, randomized, double-blind, parallel, phase IV study designed to evaluate the safety and efficacy of sovateltide (PMZ-1620, IRL-1620) as a potential treatment for cerebral ischemic stroke.
The presence of stem cells in the brain that become active after brain injury is an interesting aspect of regeneration and repair after stroke. The intravenous administration of sovateltide (TYVALZI™, IRL 1620) enhances the activity of neuronal progenitor cells and angiogenesis in the brain. This promotes the formation of new mature neurons and blood vessels, aiding in the repair process. Additionally, sovateltide exhibits anti-apoptotic activity, preventing cell death, and it can increase cerebral blood flow when administered after ischemia. These properties make sovateltide a promising candidate for promoting brain repair and facilitating recovery following acute ischemic stroke.
The study aims to evaluate the safety and efficacy of sovateltide in 160 patients with acute cerebral ischemic stroke. Sovateltide will be administered intravenously in addition to standard treatment. The patients will be divided into two groups, with 80 patients in each. Group 1 will receive sovateltide along with standard treatment, while Group 2 will receive normal saline along with standard treatment. The study will span approximately 18 months, with a patient enrollment period of around 15 months. Each patient will be followed for a total of 3 months, with three study visits during that period. The study will adhere to ethical guidelines and obtain informed consent from patients or their legally acceptable representatives. Efficacy analysis will be performed using statistical tests to compare outcomes between the groups, including NIHSS (National Institutes of Health Stroke Scale), mRS (Modified Rankin Scale), and BI (Barthel index) scores. Safety analysis will involve monitoring and categorizing adverse events (AEs) and treatment-emergent adverse events (TEAEs) using standardized medical terminology. Adverse events will be evaluated based on their relationship to the study drug, seriousness, severity, actions taken, and outcomes. Clinical laboratory parameters, vital signs, and physical examinations will also be assessed.
Exclusion Criteria:
A total of 80 patients will be enrolled in the experimental arm. Three doses of sovateltide (each dose of 0.3 μg/kg body weight) will be given as an IV bolus in each patient (randomly assigned to this group) over one minute at an interval of 3 ± 1 hours on day 1, day 3, and day 6 (total dose/day: 0.9 μg/kg body weight). All patients will receive standard stroke treatment as provided by the specific hospital setup. Patients will be closely monitored for the qualifying stroke, followed for 3 months, and assessed for safety and efficacy parameters. Efforts will be made to administer the drug at the same time on days 1, 3, and 6.
Drug: Sovateltide
A total of 80 patients will be enrolled in this arm. Three doses of an equal volume of normal saline will be administered as an IV bolus in each patient (randomly assigned to this group) over one minute at an interval of 3 ± 1 hours on day 1, day 3, and day 6. All patients will receive standard stroke treatment as provided by the specific hospital setup. Patients will be closely monitored for the qualifying stroke, followed for 3 months, and assessed for safety and efficacy parameters. Efforts will be made to administer the drug at the same time on days 1, 3, and 6.
Other: Normal Saline
Sovateltide (Tyvalzi™) is a highly selective ETB receptor agonist (Ki values are 0.016 and 1900 nM at ETB and ETA receptors, respectively). It is being developed as a first-in-class neuronal progenitor cell therapy for acute cerebral ischemic stroke. Sovateltide has demonstrated a significant neuroprotection following cerebral ischemia in animal models, while in a clinical phase I trial it was found safe and well-tolerated in healthy human volunteers (CTRI/2016/11/007509). A phase II study (NCT04046484) in 40 patients with cerebral ischemic stroke has demonstrated its superior efficacy with a significant improvement compared to the standard of care and widens the critical time window from 4 hours to 24 hours. A phase III study (NCT04047563) has also been recently completed in 158 patients with cerebral ischemic stroke, demonstrating significant improvement compared to the standard of care.
Also known as: IRL-1620, PMZ 1620, Tycamzzi™, Tyvalzi™
Three doses of Normal Saline (0.9% NaCl solution) with a volume equal to the volume of sovateltide will be administered as an IV bolus over one minute, at an interval of 3 hours ± 1 hour on day 1. The dose will be repeated on day 3 and day 6 post-randomization. All the patients in the Normal Saline group will continue receiving standard treatment.
The proportion of patients with adverse events (AEs) and serious adverse events (SAEs)
Any unfavorable sign, symptom, or disease that occurs while using sovateltide will be reported as an adverse event (AE), including the worsening of pre-existing medical conditions. A severe medical occurrence, such as death, life-threatening situations, hospitalization, significant disability, or congenital anomalies will be reported as a serious adverse event (SAE). All AEs will be collected on CRFs from when the patient signs the informed consent form (ICF) until the study exit. Any SAE that is ongoing at the time the patient exits the study must be followed until the event is resolved or there is a satisfactory explanation that meets one of the following outcomes: 1. Resolved (With sequelae or without sequelae). 2. Death and 3. Unknown (Despite adequate follow-up).
Time frame: 90 days
The proportion of cerebral ischemic stroke patients with a change in modified Rankin Scale (mRS) score of ≥2
The mRS measures independence rather than the performance of specific tasks. It accounts for both mental and physical adaptations to neurological deficits. The scale consists of 7 grades, from 0 to 6, with 0 corresponding to no symptoms and 6 corresponding to death (1: No significant disability despite symptoms; able to carry out all usual duties and activities, 2: Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, 3: Moderate disability; requiring some help, but able to walk without assistance, 4: Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, 5: Severe disability; bedridden, incontinent, and requiring constant nursing care and attention). A score of ≤ 2 on the mRS is considered a favorable outcome with minimal or no disability. In our study, mRS will be assessed on day 1, day 2, day 3, day 6, day 30, and 3 months.
Time frame: 90 days
The proportion of cerebral ischemic stroke patients with a change in National Institute of Health Stroke Scale (NIHSS) score ≥6
NIHSS is the most widely used scale to assess stroke severity and subsequent stroke outcome. It is a 42-point scale that measures neurological deficits and contains 15 items, including the level of consciousness, language function neglect, visual fields, eye movements, facial symmetry, motor strength, sensation, and coordination. The examination can be performed quickly. The NIHSS scoring is as follows: • Score 25: Very severe neurological impairment • Score 15-24: Severe impairment • Score 5-14: Moderately severe impairment • Score \< 5: Mild impairment. NIHSS has been used extensively in clinical studies to measure stroke outcomes and has been validated and standardized to reduce inter-observer error. It will be assessed on day 1, day 2, day 3, day 6, day 30, and 3 months. In the case of dosing days (day 1, day 3, and day 6), the NIHSS score will be measured before administering the first study dose.
Time frame: 90 days
The proportion of cerebral ischemic stroke patients with a change in Barthel index (BI) score ≥60
The BI is considered a reliable disability scale for stroke patients. It is a 10-item scale on which disability is assessed by various aspects of self-care (feeding, grooming, bathing, dressing, bowel and bladder care, and toilet use) and a group related to mobility (ambulation, transfers, and stair climbing). Patients who score 100 (maximum score) on BI are fully independent in physical functioning. They are continent, can feed and dress themselves, get out of bed, walk more than 1 block, and perform activities of daily living. The lowest score is 0, representing a totally dependent bedridden state. Barthel index will be assessed on day 1, day 2, day 3, day 6, day 30, and 3 months.
Time frame: 90 days
Change in National Institute of Health Stroke Scale (NIHSS) score
NIHSS is the most widely used scale to assess stroke severity and subsequent stroke outcome. It is a 42-point scale that measures neurological deficits and contains 15 items, including the level of consciousness, language function neglect, visual fields, eye movements, facial symmetry, motor strength, sensation, and coordination. The examination can be performed quickly. The NIHSS scoring is as follows: • Score 25: Very severe neurological impairment • Score 15-24: Severe impairment • Score 5-14: Moderately severe impairment • Score \< 5: Mild impairment. It will be assessed on day 1, day 2, day 3, day 6, day 30, and 3 months. In the case of dosing days (day 1, day 3, and day 6), the NIHSS score will be measured before administering the first study dose. Relative change at various time points will be calculated in each patient and improvement will be analyzed.
Time frame: 90 days
Change in modified Rankin Scale (mRS) score
The mRS scale consists of 7 grades, from 0 to 6, with 0 corresponding to no symptoms and 6 corresponding to death (1: No significant disability despite symptoms; able to carry out all usual duties and activities, 2: Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, 3: Moderate disability; requiring some help, but able to walk without assistance, 4: Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, 5: Severe disability; bedridden, incontinent, and requiring constant nursing care and attention). The mRS scoring will be assessed on day 1, day 2, day 3, day 6, day 30, and 3 months. Relative change in mRS at various time points will be calculated in each patient and improvement will be analyzed.
Time frame: 90 days
Change in Barthel index (BI) score
BI (Barthel Index) score is a 10-item scale on which disability is assessed by various aspects of self-care (feeding, grooming, bathing, dressing, bowel and bladder care, and toilet use) and a group related to mobility (ambulation, transfers, and stair climbing). Patients who score 100 (maximum score) on BI are fully independent in physical functioning. They are continent, can feed and dress themselves, get out of bed, walk more than 1 block, and perform activities of daily living. The lowest score is 0, representing a totally dependent bedridden state. BI will be assessed on day 1, day 2, day 3, day 6, day 30, and 3 months. Relative change in BI at various time points will be calculated in each patient and improvement will be analyzed.
Time frame: 90 days
Change in Quality-of-life as assessed by EuroQol-EQ-5D
EuroQol-EQ-5D is a generic measure of health status developed by an international research group, the EuroQol Group. EuroQol-EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is divided into 5 levels: no problem, slight problem, moderate problem, severe problem, and extreme problem. The scale is numbered from 0 to 100; 100 means the best health you imagine, and 0 is the worst health you imagine. The patient indicated his/her health by marking it on a numbered scale. EuroQol will be assessed on day 1, day 6, day 30, and 3 months. Relative change in EuroQol at various time points will be calculated in each patient and improvement will be analyzed.
Time frame: 90 days
Change in Stroke-Specific Quality of Life (SSQOL)
The SS-QOL is a self-report questionnaire consisting of 49 items in the 12 domains of energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity function, vision, and work/productivity. The domains are scored separately, and a the total score is provided, with a minimum value of 1 (meaning the worst outcome) and a the maximum value of 5 (meaning the best outcome). SS-QOL will be assessed on days 6, day 30, and 3 months. Relative change in SS-QOL at various time points will be calculated in each patient and improvement will be analyzed.
Time frame: 90 days
The proportion of patients with recurrent cerebral ischemic stroke
The data on stroke recurrence are helpful in examining trends, risk factors, and treatment effects. Our study will assess the proportion of patients with recurrent cerebral ischemic stroke in sovateltide treated versus placebo-treated patients within 90 days of post-randomization.
Time frame: 90 days
Number of deaths
Mortality or death is an indicator of the treatment risk factors as well as its effects on ischemic stroke. Mortality will be assessed and compared in the placebo and sovateltide patients within 90 days post-randomization.
Time frame: 90 days
Proportion of patients with radiographic or symptomatic intracerebral hemorrhage (ICH)
Intravenous thrombolysis (e.g., use of t-PA) is the most prevalent treatment strategy for acute ischemic stroke; however, it is associated with thrombolysis-related symptomatic intracerebral hemorrhage (ICH), which occurs in nearly 6% of patients and carries close to 50% mortality. Hence, an assessment of ICH is recommended for the development of new therapeutics to treat ischemic stroke. In our study, radiographic or symptomatic ICH will be assessed in the placebo as well as in sovateltide-treated patients and their proportion will be analyzed.
Time frame: 30 hours
Compare baseline Alberta Stroke Program Early CT (ASPECT) Score for stroke severity and identify sites of ischemic lesions
The Alberta Stroke Programme Early Computed Tomography Score (ASPECTS) is widely used to determine the extent of early ischemic changes in brain imaging for acute stroke and is recognized by the American Heart Association guidelines for managing acute stroke. The ASPECT score is a 10-point quantitative score wherein 1 point is deducted for each defined middle cerebral artery (MCA) area showing any evidence of early ischemic change. The ten defined MCA regions include M1 - Anterior MCA cortex, M2 - MCA cortex lateral to the insular ribbon, M3 - posterior MCA cortex, M4 - anterior MCA territory, M5 - lateral MCA territory, M6 - posterior MCA territory, C - Caudate, L - Lentiform Nucleus, I - Insula, and IC - Internal Capsule. A score of 0 would indicate infarction of all 10 regions.
Time frame: 90 days
Plan to share: No — Plan to publish the findings after completion of the study.
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Pharmazz, Inc.