WILLOWBROOK, III., Feb. 13, 2023. Pharmazz, Inc. (“Pharmazz” or the “Company”), a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care, announced that the US Food and Drug Administration (FDA) has issued a proceed forward letter regarding the Company’s Investigational New Drug (“IND”) application that includes the protocol entitled, “A Multicentric, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase III Study To Assess The Safety And Efficacy Of Sovateltide In Patients With Acute Cerebral Ischemic Stroke.” The FDA completed a safety review of the protocol and concluded that the Company could proceed with the proposed clinical investigation. Since this upcoming trial may be used as a potential pivotal efficacy study to support a future NDA, Pharmazz plans to incorporate the FDA’s suggestions to the study design and update the protocol for a Special Protocol Assessment as recommended by the FDA.
“FDA clearance of our Phase III trial is a significant milestone for Pharmazz and the potential future treatment of acute ischemic stroke patients,” said Anil Gulati, M.D., Ph.D. Inventor, Chief Executive Officer, and Chairman of the Board of Pharmazz. In October last year, we reported the results of our successful Phase III trial in acute cerebral ischemic stroke patients that we conducted in India. That trial demonstrated a significantly (p=0.0045) greater number of patients showing an improvement of 2 or more points on the modified Rankin Score (mRS). Additionally, the proportion of acute cerebral ischemic stroke patients with the mRS of 0-2 on day 90 post-randomization was statistically significant (p=0.002), which is the primary endpoint for the US trial. Moreover, the drug was well tolerated, with no drug-related adverse events reported. The full data set from the successful Indian Phase III trial was presented last week at the American Stroke Association International Stroke Conference on February 9 2023, in Dallas, TX. That trial reassures us that the US trial could generate a similar outcome.The upcoming US Phase III trial is designed as a randomized, double-blind, placebo-controlled study to assess the safety and efficacy of sovateltide in 444 patients with acute cerebral ischemic stroke. Patients will be randomized 1:1 to receive either 3 doses of sovateltide, at a dose of 0.3 μg/kg as an intravenous bolus over 1 minute every 3 hours ± 1 hour on days 1, 3, and 6 plus standard of care, or placebo injections at the same time points plus standard of care. The primary endpoint is the proportion of acute cerebral ischemic stroke patients having a good functional outcome with the mRS of 0-2 on day 90 post-randomization. Key secondary endpoints include the proportion of acute cerebral ischemic stroke patients having an excellent functional outcome with the mRS of 0-1 on day 90 post-randomization and the proportion of cerebral ischemic stroke patients with NIHSS score ≥ 6, mRS > 2, and BI score ≤ 60 on day 6, day 30, and day 90 post-randomization and the number of deaths within day 90 post-randomization, and any adverse events or serious adverse events associated with sovateltide. More details on the clinical trial design, including the complete list of secondary endpoints, can be found on clinicaltrials.gov (NCT05691244).
SOURCE Pharmazz, Inc.
Posted: February 2023
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