Sovateltide significantly (p=0.0157) improved clinical outcome (modified Rankin Scale) in patients with acute cerebral ischemic stroke when compared to standard of care
WILLOWBROOK, Ill., April 27, 2020 /PRNewswire/ -- Pharmazz, Inc., a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat patients in critical care, today announced that sovateltide, an endothelin-B receptor agonist, significantly (p=0.0157; two-tailed unpaired t-test; t=2.476; df=70) improved modified Rankin Scale (mRS) of acute cerebral ischemic stroke patients when compared to patients receiving the best standard of care. These results are based on an interim 30-day analysis of multicentric, randomized, blinded, controlled efficacy clinical trials (NCT04046484; NCT04047563) in acute ischemic stroke patients. Modified Rankin Scale in patients receiving sovateltide had a difference of means of 2.40 (95%CI of difference 1.99 to 2.80; N=35) whereas in control patients the difference of means was 1.64 (95%CI of difference 1.22 to 2.07; N=37). Modified Rankin Scale is the recommended and most frequently used primary outcome scale in acute cerebral ischemic stroke clinical trials. National Institutes of Health Stroke Scale (NIHSS) improved with sovateltide (difference of means=7.00) compared to control (difference of means=6.23) and Barthel Index (BI) also improved with sovateltide (difference of means=47.36) compared to control (difference of means=42.30), however, they did not reach the level of statistical significance. The study is continuing to enroll patients and monitor patients till 90 days post randomization. Sovateltide was administered intravenously within 24 hours after the onset of stroke. No incidence of drug related adverse event was reported. It has the potential to be a first-in-class neuronal progenitor cell therapeutics that has the potential to significantly improve neurological outcome in acute cerebral ischemic stroke patients.
Since US FDA recommended, in our pre-IND meeting, to keep mRS as the primary endpoint, we are encouraged by these results and planning to move forward with IND submission to the US FDA. In addition, the Company is continuing multicentric, randomized, double blind, parallel, saline controlled clinical trials using sovateltide in Alzheimer's disease (NCT04052737) and acute spinal cord injury (NCT04054414). Both studies have crossed 50% of enrollment.
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.