Dosing of first patient in phase 3 pivotal study of sovateltide (PMZ-1620), a first-in-class investigational product, for acute cerebral ischemic stroke
WILLOWBROOK, Ill., Nov. 23, 2019 /PRNewswire/ -- 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.
This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties including the risk that Pharmazz, Inc. cannot execute its business plan for lack of capital or other resources, distribution, partnering or licensing/acquisition opportunities. Actual events or results may differ materially from those projected in any of such statements due to various factors. Any of these risks could cause Pharmazz, Inc. or its industry's, actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by the forward-looking statements in this presentation. Except as required by applicable law Pharmazz, Inc. does not intend to update any of the forward-looking statements to conform these statements to actual results.
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SOURCE Pharmazz, Inc.