Pharmazz Inc. announces Indian Central Drugs Standard Control Organization (CDSCO) Clearance of IND to conduct a Phase II clinical trial of sovateltide (PMZ-1620) in hypoxic-ischemic encephalopathy in neonates

Willowbrook, Illinois, UNITED STATES

Sovateltide is an endothelin-B receptor agonist that is neuroprotective, neurorestorative, and produces neurovascular remodeling

Sovateltide marketing authorization for the treatment of acute cerebral ischemic stroke is under review by CDSCO

WILLOWBROOK, Ill., Aug. 29, 2022 (GLOBE NEWSWIRE) -- Pharmazz, Inc. (“Pharmazz”), a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care, today announced the clearance of an Investigational New Drug (IND) application by the India Central Drugs Standard Control Organization (CDSCO) to conduct a Phase II clinical trial of sovateltide in hypoxic-ischemic encephalopathy (HIE) in neonates. Sovateltide is the Company’s endothelin-B receptor agonist that increases blood flow, shows anti-apoptotic activity, protects neural mitochondria, and produces neurovascular remodeling. Sovateltide is currently undergoing marketing authorization review by CDSCO to treat acute cerebral ischemic stroke.

“HIE is a devastating complication of birth that can lead to serious disability or death in a significant percentage of neonates who suffer from it,” said Anil Gulati, M.D., founder, Chief Executive Officer, and Chairman of the Board of Pharmazz. “Brain damage in HIE is caused by acute hypoxia, oxidative stress, and persistent inflammation. Endothelin-B receptor agonism is neuroprotective and neurorestorative by directly addressing and countering these pathological processes. This activity has been demonstrated with sovateltide in an animal model for HIE. Improved neurological outcomes demonstrated in our pivotal trial of sovateltide in acute ischemic stroke in humans, an acute condition with underlying pathologic mechanisms similar to HIE, also suggest that it could improve the outcomes of newborns who suffer from HIE. The initiation of Phase II of this trial, which we expect to occur in October 2022, is another example of our commitment to patients in critical medical conditions.”

The Phase II trial is a multicenter, randomized, double-blind, placebo-controlled study that will enroll 40 neonates with birth asphyxia to assess the efficacy and safety of sovateltide for treating HIE. Subjects will receive either three intravenous doses of sovateltide, 0.3 ug/kg on days 1, 3, and 6, or a placebo. The primary endpoint of this trial is the percentage of patients with death or moderate to severe disability, a composite measure of death or moderate/severe disability at 24 months. In addition, several secondary efficacy and safety endpoints will also be measured. More information on the clinical trial can be found at NCT05514340.

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

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Burns McClellan, Inc.

Shruti Gulati
Pharmazz Inc.
Phone: (630) 780-6087