Pharmazz gets CDSCO nod for Phase II trial of sovateltide in hypoxic-ischemic encephalopathy in neonates
Willowbrook: Pharmazz, Inc., a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care, has 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.
