A Multicenter, Randomized Trial to Assess Safety, and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmazz, Inc.

Criteria

Inclusion Criteria:

1. Either sex with ≥ 36 weeks of gestational age

2. Receiving supportive management for perinatal asphyxia

3. 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.

4. Informed consent by one of the parents or a legal representative

Exclusion Criteria:

1. Gestational age <36 weeks

2. Admitted to hospital 12-hours after birth

3. A genetic or congenital condition that affects neuronal development

4. TORCH infection

5. Neonatal sepsis

6. Complex congenital heart disease

7. Severe dysmorphic feature

8. Microcephaly (head circumference < 2 Standard Deviations below mean for gestational age)