Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy

NCT05514340 | Recruiting Phase 2 DMC

• 1 other identifier: PMZ-1620/CT-2.4/2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Neonatal Encephalopathy; Neonatal Asphyxia; Hypoxic-Ischemic Encephalopathy

Keywords

Hypoxic-Ischemic Encephalopathy; Cerebral Asphyxia; Neonatal Encephalopathy

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with death or disability (moderate/severe)

  Percentage of patients with death or disability (moderate/severe). Severe disability is defined as any of the following: a Bayley composite cognitive score \<70, a GMFCS grade of level 3 to 5, hearing impairment requiring hearing aids, or blindness (vision \<20/200). Moderate disability is defined as a composite cognitive score 70 - 84, in addition, one or more of the following: GMFCS grade of level 2, unilateral blindness (vision 20/200 in only one eye), or hearing impairment with no amplification/cochlear implant.

  24 months

Secondary Outcomes (7)

• Bayley Scales of Infant and Toddler Development Scores

  24 months

• Disabling cerebral palsy

  24 months

• Seizures

  24 months

• Brain injury

  14 days]

• Blindness or hearing impairment

  24 months

Study Arms (2)

Normal Saline + Standard of care

ACTIVE COMPARATOR

Patients will receive the best available standard of care. Normal saline will be administered as an intravenous bolus over one minute every 3 hours on day 1, day 3, and day 6 post randomizations.

Drug: Normal Saline along with standard treatment

Sovateltide + Standard of care

EXPERIMENTAL

Patients will receive the best available standard of care. Dose of sovateltide (0.3 µg/kg) will be administered as an intravenous bolus over one minute every 3 hours on day 1, day 3, and day 6 post randomizations.

Drug: Sovateltide along with standard treatment

Interventions

Sovateltide along with standard treatment DRUG

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.

Also known as: PMZ-1620

Sovateltide + Standard of care

Normal Saline along with standard treatment DRUG

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.

Also known as: Vehicle

Normal Saline + Standard of care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pharmazz, Inc.: lead

Study Sites (4)

Father Muller Medical College Hospital

Mangalore, Karnataka, 575002, India

RECRUITING

Christian Medical College and Hospital

Ludhiana, Punjab, 141008, India

RECRUITING

Niloufer Hospital

Hyderabad, Telangana, 500 004, India

NOT YET RECRUITING

GSVM Medical College

Kanpur, Uttar Pradesh, 208002, India

NOT YET RECRUITING

Related Publications (4)

• Ramos MD, Briyal S, Prazad P, Gulati A. Neuroprotective Effect of Sovateltide (IRL 1620, PMZ 1620) in a Neonatal Rat Model of Hypoxic-Ischemic Encephalopathy. Neuroscience. 2022 Jan 1;480:194-202. doi: 10.1016/j.neuroscience.2021.11.027. Epub 2021 Nov 23.

  PMID: 34826534 BACKGROUND

• Ranjan AK, Gulati A. Sovateltide Mediated Endothelin B Receptors Agonism and Curbing Neurological Disorders. Int J Mol Sci. 2022 Mar 15;23(6):3146. doi: 10.3390/ijms23063146.

  PMID: 35328566 BACKGROUND

• Gulati A, Agrawal N, Vibha D, Misra UK, Paul B, Jain D, Pandian J, Borgohain R. Safety and Efficacy of Sovateltide (IRL-1620) in a Multicenter Randomized Controlled Clinical Trial in Patients with Acute Cerebral Ischemic Stroke. CNS Drugs. 2021 Jan;35(1):85-104. doi: 10.1007/s40263-020-00783-9. Epub 2021 Jan 11.

  PMID: 33428177 BACKGROUND

• Ranjan AK, Briyal S, Gulati A. Sovateltide (IRL-1620) activates neuronal differentiation and prevents mitochondrial dysfunction in adult mammalian brains following stroke. Sci Rep. 2020 Jul 29;10(1):12737. doi: 10.1038/s41598-020-69673-w.

  PMID: 32728189 BACKGROUND

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Asphyxia Neonatorum

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Anil Gulati

  Chairman and CEO

  STUDY CHAIR

Central Study Contacts

Manish S Lavhale

CONTACT

+91 9873847397; manish.lavhale@pharmazz.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In this double-blind study, the patient and all relevant personnel involved with the conduct and interpretation of the study (including the investigator, investigational site personnel, and the sponsor or designee's staff) will remain blinded to the identity of the Investigational Product (IP) assigned and the randomization codes. The final randomization list will be kept strictly confidential, filed securely by the independent biostatistician, and accessible only to authorized persons as per the sponsor's standard operating procedures until the completion of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In sovateltide group, 3 doses of sovateltide, at 0.3 μg/kg body weight will be administered as an intravenous bolus over 1 minute every 3 hours ± 1 hour on day 1, 3, and day 6 (total dose/day: 0.9 µg/kg body weight). In control group, 3 doses of equal volume of normal saline will be administered as an IV bolus over 1 minutes every 3 hours ± 1 hour on day 1, 3 and day 6 post randomization. In both treatment groups, subjects will be provided the best available standard of care.

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 24, 2022
• Study Start: September 6, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (4)