Dosing of first patient in phase 3 pivotal study of sovateltide (PMZ-1620), a first-in-class investigational product, for acute cerebral ischemic stroke
- Category: Small Molecules
- Published on Sunday, 24 November 2019 12:18
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WILLOWBROOK, IL, USA I November 23, 2019 I Pharmazz, Inc., a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat patients in critical care, today announced the initiation of dosing in its pivotal, phase 3 clinical trial evaluating sovateltide for the treatment of acute cerebral ischemic stroke. The first patient was dosed on November 10, 2019 and in less than 15 days a total of 7 patients have been enrolled as part of multicentric, randomized study (NCT04047563) in India. The trial is expected to enroll approximately 110 patients with acute cerebral ischemic stroke and top-line results from this phase 3 trial are expected by middle of 2020.
Phase 2 clinical trial results were presented at the American Heart Association Scientific Sessions 2019, November 16 to18, 2019 at Philadelphia (Abstract # 14683 and 13805). The results of phase 2 study (NCT04046484) indicate that clinical outcomes of NIHSS, mRS and BI on day 6 showed statistically significant improvement in sovateltide group compared to standard treatment indicating a rapid improvement in clinical outcome. It was further found that statistically significant number of patients recovered fully with NIHSS of 0 and BI of 100 in sovateltide group compared to control group receiving standard treatment in a 90-day study.
The company further announces that Australia patent number 2014287427, titled "Compositions and methods for treating neuropsychiatric disorders using an endothelin-B receptor agonist" was awarded on October 29, 2019.
About Pharmazz, Inc.
Pharmazz, Inc. is a privately held company engaged in the development of novel products in the area of critical care medicine. Additional information may be found on the Company's website, www.pharmazz.com.