RecruitingPhase 2NCT05514340

Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy

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

Sponsor

Pharmazz, Inc.

Enrollment

40 participants

Start Date

Sep 6, 2023

Study Type

INTERVENTIONAL

Conditions

Neonatal Encephalopathy Neonatal Asphyxia Hypoxic-ischemic encephalopathy.

Summary

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.

Eligibility

Inclusion Criteria8

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

Exclusion Criteria8

Gestational age <36 weeks
Admitted to hospital 12-hours after birth
A genetic or congenital condition that affects neuronal development
TORCH infection
Neonatal sepsis
Complex congenital heart disease
Severe dysmorphic feature
Microcephaly (head circumference < 2 Standard Deviations below mean for gestational age)

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Interventions

DRUGNormal Saline along with standard treatment

Sovateltide is an endothelin-B receptor agonist. It has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in hypoxic-ischemic encephalopathy patients. In this arm normal saline along with standard treatment will be given for active comparison.

DRUGSovateltide along with standard treatment

Sovateltide is an endothelin-B receptor agonist. It has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in hypoxic-ischemic encephalopathy patients. In this arm sovateltide along with standard treatment will be given for active comparison.