A Special Protocol Assessment Agreement Reached with the U.S. Food and Drug Administration for Phase 3 clinical trial of Sovateltide for the treatment of acute cerebral ischemic stroke patients

  • Sovateltide stimulates neural progenitor cells in the brain and promotes neurovascular remodeling by forming new neurons (neurogenesis) and blood vessels (angiogenesis). Sovateltide also protects neural mitochondria and enhances their biogenesis.
  • Sovateltide is being marketed in India by Sun Pharmaceuticals under its brand name Tyvalzi™ and can be administered up to 24 hours after the onset of symptoms.

WILLOWBROOK, Ill., Oct. 02, 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 it has received agreement from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the study design and statistical analysis plan of its Phase 3 clinical trial of Sovateltide (Tycamzzi™) for the treatment of acute cerebral ischemic stroke patients. The protocol is titled "The Safety And Efficacy Of Sovateltide In Patients With Acute Cerebral Ischemic Stroke." The FDA completed its review and agreed that the study's design and planned analysis could adequately address objectives supporting regulatory submission and a future marketing application with the US FDA. The final determination for the approval of the marketing application is made after a complete review. The FDA previously approved the phase 3 IND application. This SPA agreement by the FDA provides a clear-cut regulatory path for sovateltide, our first-in-class drug for acute cerebral ischemic stroke. In addition, our SPA agreement with the FDA solidifies our trial's alignment with regulatory objectives and underscores the FDA's confidence in Sovateltide's potential. It's a seal of approval that offers our team and investors unique assurance. Sovateltide will fulfill an unmet medical need since no new drug other than rtPA has been approved for treating stroke for over two decades. The narrow time window of rtPA of 4.5 hours limits its use in most patients with cerebral ischemic stroke. Sovateltide is a true standout; it can be administered up to 24 hours following the onset of stroke symptoms, presenting a remarkable market advantage.

This is a multicenter, randomized, double-blind, placebo-controlled phase 3 clinical study to assess the safety and efficacy of sovateltide along with the standard of care in patients with acute cerebral ischemic stroke. The target population is adult patients aged 18 – 80 years of age with cerebral ischemic stroke presenting within 24 hours after the onset of symptoms with NIHSS score of ≥8 and <20 as well as NIHSS Level of Consciousness (1A) score <2 at the time of screening. This includes cerebral ischemic stroke patients who completely recovered from earlier episodes before having a new or fresh stroke. The primary endpoint is the proportion of acute cerebral ischemic stroke patients having a good functional outcome with a modified Rankin Scale (mRS) score of 0-2 on day 90 post-randomization. For an individual patient, the duration of the study will be 3 months (90 days), with 4 study visits. Five hundred and fourteen patients (257 in each treatment arm) will be randomized into 2 groups and stratified based on early vs. late enrollment (<12 hours vs. ≥12 hours) and by the use vs. non-use of rtPA.

About Pharmazz, Inc.

Pharmazz is a privately held company engaged in developing novel products in critical care medicine. Pharmazz, Inc. obtained marketing authorization for two of its first-in-class drug molecules, Centhaquine and Sovateltide, for hypovolemic shock and ischemic stroke, respectively, in India. In addition, U.S. Food and Drug Administration (FDA) has approved two phase 3 INDs for Centhaquine as an agent for hypovolemic shock and Sovateltide for cerebral ischemic stroke. Additional information may be found on the Company's website, www.pharmazz.com.

Contacts: Pharmazz, Inc.

David Costello
Shruti Gulati
Tel+1 630 780 6087Tel+1 630 780 6087
E maildavid.costello@pharmazz.comE mailshruti.gulati@pharmazz.com