Pharmazz, Inc. Announces Marketing Approval of Sovateltide in India for Acute Cerebral Ischemic Stroke Patients

2023-05-31

临床3期临床结果上市批准

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)

Sovateltide is a first-in-class drug that increases blood flow, inhibits apoptosis, and induces neurovascular remodeling

WILLOWBROOK, Ill., May 31, 2023 (GLOBE NEWSWIRE) -- 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 Directorate General of Health Services, India on May 31st, 2023, granted the manufacture and marketing of Sovateltide Injection for cerebral ischemic stroke patients. The company is preparing to launch Sovateltide, an endothelin-B receptor agonist, for the treatment of patients with acute cerebral ischemic stroke. The company plans to make Sovateltide available to patients in India in the third quarter of 2023.

“Marketing authorization is a significant milestone for Pharmazz and acute ischemic stroke patients in India,” said Anil Gulati, M.D., Ph.D. Inventor, Chief Executive Officer, and Chairman of the Board of Pharmazz. “Previously, 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). Moreover, the drug was well tolerated, with no drug-related adverse events reported.”

In addition, 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.” Pharmazz is working with the FDA on suggestions for the study design and updating the protocol for a Special Protocol Assessment. More details on the clinical trial design, including the complete list of secondary endpoints, can be found on clinicaltrials.gov (NCT05691244).

About Pharmazz, Inc.

Pharmazz, Inc. is a privately held company developing novel products in critical care medicine. Additional information may be found on the Company’s website, www.pharmazz.com.

Media Contact:

Shruti Gulati

Pharmazz Inc.

Email: shruti.gulati@pharmazz.com

Phone: (630) 780-6087

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