Condition: Acute Ischemic Stroke · Cerebral Stroke · Sponsor: Pharmazz, Inc.
Extensive research is being conducted in search of neuroprotective agents for possible use in the acute phase of stroke and agents that can be used for neurorepair in later stages of stroke. Several trials have been conducted and are in progress using different pharmacological agents, but none of the studies involve the stimulation of ETB receptors to treat cerebral ischemic stroke. Sovateltide (IRL-1620, PMZ-1620) has been effective in animal models of cerebral ischemic stroke. Its safety and tolerability have been demonstrated in a human phase I study with 7 subjects. Clinical phase II and III results indicate that sovateltide is a novel, first-in-class, highly effective drug candidate for treating cerebral ischemic stroke. Safety and significant efficacy in improving the National Institutes of Health Stroke Scale (NIHSS), Modified Rankin scale (mRS), and Barthel index (BI) obtained in phase II and III studies in patients with cerebral ischemic stroke in India are convincing and encouraged us to investigate its safety and efficacy in cerebral ischemic stroke patients in the United States. Therefore, the plan is to conduct a phase III clinical study to evaluate the safety and efficacy of sovateltide therapy along with standard of care in patients of acute ischemic stroke.
This description comes directly from the study's public registry record.
Anil Gulati, MD, PhD · 6307806087 · anil.gulati@pharmazz.com
Neil Marwah, MD · 6307806087 · neil.marwah@pharmazz.com
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| The University of Arizona - College of Medicine | Tucson, Arizona, United States | Recruiting |
| Mercy Medical Group | Carmichael, California, United States | Recruiting |
| St. John's Regional Medical Center | Oxnard, California, United States | Recruiting |
| Sarasota Memorial Hospital | Sarasota, Florida, United States | Recruiting |
| Wellstar Kennestone Hospital | Marietta, Georgia, United States | Recruiting |
| SSM Health Neurosciences | Bridgeton, Missouri, United States | Recruiting |
| Hackensack University Medical Center at Paramus | Paramus, New Jersey, United States | Recruiting |
| Guilford Neurologic Associates Inc | Greensboro, North Carolina, United States | Recruiting |
| OSU Wexner Medical Center | Columbus, Ohio, United States | Recruiting |
| Penn State Health Milton S. Hershey Medical Center | Hershey, Pennsylvania, United States | Recruiting |
| UPMC Presbyterian Hospital | Pittsburgh, Pennsylvania, United States | Recruiting |
| CHI Memorial Neuroscience Institute | Chattanooga, Tennessee, United States | Recruiting |
+ 42 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05691244