A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase-II Trial to Assess Safety, and Efficacy of Sovateltide in the Treatment of Hypoxic-ischemic Encephalopathy in Neonates
Sovateltide (PMZ-1620; IRL-1620) is targeted to be used as a Treatment for hypoxic-ischemic encephalopathy in neonates, which is a life-threatening condition. Sovateltide augments neuronal progenitor cell differentiation and better mitochondrial morphology and biogenesis to activate a regenerative response in the central nervous system. The only treatment for HIE is therapeutic hypothermia with limited success, and studies indicate that sovateltide may be beneficial in these patients.
• Either sex with ≥ 36 weeks of gestational age
• Receiving supportive management for perinatal asphyxia
• Perinatal depression, based on at least one of the following:
‣ Apgar score of \<5 at 10 minutes
⁃ Need for resuscitation (chest compressions or mechanical ventilation) at birth
⁃ pH \<7.00 or base deficit ≥ 16 mmol/liter in the cord or arterial blood within 60 minutes of birth
⁃ Moderate/severe encephalopathy evident by at least 3 of 6 modified Sarnat criteria, present between 1 to 6 hours of birth.
• Informed consent by one of the parents or a legal representative