Pharmazz Inc. Submits INDA to India Central Drugs Standard Control Organization for Phase 2 Clinical Trial of Sovateltide in Hypoxic-Ischemic Encephalopathy in Neonates
Pharmazz, Inc. recently announced it has submitted an Investigational New Drug Application (INDA) to the India Central Drugs Standard Control Organization (CDSCO) for a Phase 2 clinical trial of sovateltide in hypoxic-ischemic encephalopathy (HIE) in neonates. Sovateltide is the company’s endothelin-B receptor agonist that is also in a Phase 3 trial for the treatment of 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, MD, founder, Chief Executive Officer, and Chairman of the Board of Pharmazz. “The only approved treatment for HIE is therapeutic hypothermia with limited success. Sovateltide’s biological properties are such that it could potentially improve the outcomes of newborns who suffer from HIE. The initiation of Phase 2 of this trial is another example of our commitment to patients in critical medical conditions.”
The Phase 2 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 the treatment of 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. The key secondary endpoints are (1) changes in Bayley Scales of Infant and Toddler Development Scores measured every 6 months interval till 24 months; (2) change in the proportion of children with disabling cerebral palsy at 24 months; (3) change in the proportion of patients with seizures at birth, at 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, 7 days, 30 days, 6 months after initiation of treatment, and then at every 6 months interval till 24 months; (4) the number of patients with MRI or EEG evidence of brain injury at 14 days of initiation of treatment; and (5) incidence of sovateltide related adverse events during 24 months.
Pharmazz, Inc. is a privately held company engaged in developing novel products in critical care medicine. For more information, visit www.pharmazz.com.
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