PMZ-1620 (Sovateltide) in Patients of Acute Spinal Cord Injury

NCT04054414 | Recruiting Phase 2 DMC

• 2 other identifiers: PMZ-1620/CLINICAL-2.3/2017CTRI/2018/12/016667
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

Brief Summary

This was a prospective, multicentric, randomized, double blind, parallel, saline controlled Phase II clinical study to compare the safety and efficacy of PMZ-1620 (INN: Sovateltide) therapy along with standard supportive care in patients of acute spinal cord injury.

Conditions

Acute Spinal Cord Injury

Keywords

Endothelin; Neurogenesis

Outcome Measures

Primary Outcomes (2)

• Incidence of PMZ-1620 related adverse events

  The primary objective of the study is to determine incidence of drug (PMZ-1620) related adverse events.

  90 days

• Number of patients not receiving full treatment

  Tolerability will be determined by the number of patients that do not receive all the 9 doses of PMZ-1620.

  90 days

Secondary Outcomes (5)

• Changes in clinical progression of International Standards for Neurological Classification of spinal cord injury (ISNCSCI)

  90 days

• Changes in walking index for spinal cord injury (WISCI) score

  90 days

• Changes in Spinal Cord Independence Measure (SCIM) score

  90 days

• Changes in MRI/CT

  90 days

• Changes in electromyography (EMG)

  90 days

Study Arms (2)

Normal Saline

ACTIVE COMPARATOR

Patients will receive the best available standard of care. 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.

Drug: Normal Saline along with standard treatment

PMZ-1620

EXPERIMENTAL

Patients will receive the best available standard of care. In PMZ group, 3 doses of PMZ-1620, 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).

Drug: PMZ-1620 along with standard treatment

Interventions

Normal Saline along with standard treatment DRUG

The arm is for active comparison for PMZ-1620 (sovateltide), an endothelin-B receptor agonist. PMZ-1620 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 cerebral ischemic stroke patients. Normal saline (vehicle) with standard treatment will be provided.

Also known as: Vehicle

Normal Saline

PMZ-1620 along with standard treatment DRUG

PMZ-1620 (sovateltide) is an endothelin-B receptor agonist. PMZ-1620 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 cerebral ischemic stroke patients.

Also known as: Sovateltide (IRL-1620) along with standard treatment

PMZ-1620

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males or females aged between 18 and 75 years inclusive
• Able to give consent for participation on their own or through their Legally Acceptable Representative (LAR)
• Able to cooperate in the completion of a standardized neurological examination by ISNCSCI standards (excludes patients who are on ventilator)
• ISNCSCI Impairment Scale Grade "B," "C" or "D" based upon first ISNCSCI evaluation after arrival to the hospital is classified as motor or sensory incomplete
• Willing and able to comply with the study Protocol
• Women must be of non-childbearing potential or surgically sterile or willing to use adequate birth control; men who are sexually active will also be required to use adequate birth control
• Able to receive the Investigational Drug within 48 hours of injury
• Neurological Level of Injury between C5-C8, T1-T12, L1-L5 and S1-S5 based upon first ISNCSCI evaluation after arrival to the hospital
• Patient with incomplete/partial damage/transaction as shown by CT or MRI scan
• Patients with any other chronic conditions, who are stable with appropriate treatment

You may not qualify if:

• Previous history related to spinal cord disease
• Patient on ventilator or requires ventilator
• Patient with pathological fracture of vertebral column
• Impairment Scale Grade "A" based upon first ISNCSCI assessment and classified as complete injury
• One or more upper extremity muscle groups un-testable during baseline ISNCSCI examination
• Concomitant head injury with a clinically significant abnormality on a head CT (head CT required only for patients suspected to have a brain injury at the discretion of the investigator)
• Females who are breastfeeding or have a positive urine pregnancy test
• Body mass index (BMI) of ≥35 kg/m2 at screening
• Known immunodeficiency, including human immunodeficiency virus, or use of immunosuppressive or cancer chemotherapeutic drugs
• Patient having rheumatoid arthritis
• The participant has a clinically significant cardiovascular disorder or an abnormal electrocardiogram (ECG) at the discretion of the investigator
• Pre-existent neurologic disorder which would preclude accurate evaluation and follow-up (i.e. Alzheimer's disease, Parkinson's disease, any psychiatric disorder with hallucinations/delusions/schizophrenia)
• Patients who are currently participating in a clinical trial with an investigational drug or investigational device
• Patients who, in the opinion of the investigator, are otherwise unsuitable for this study

Sponsors & Collaborators

• Pharmazz, Inc.: lead

Study Sites (5)

KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre

Belagavi, 590010, India

NOT YET RECRUITING

Institute of Postgraduate Medical Education & Research and SSKM Hospital

Kolkata, 700020, India

RECRUITING

King George's Medical University

Lucknow, 226018, India

RECRUITING

Rahate Surgical Hospital & ICU

Nagpur, 440008, India

RECRUITING

Indian Spinal Injury Centre

New Delhi, 110070, India

RECRUITING

MeSH Terms

Interventions

sovateltide

Study Officials

• Anil Gulati

  Pharmazz, Inc.

  STUDY CHAIR

Central Study Contacts

Manish S Lavhale

CONTACT

+91 9873847397; manish.lavhale@pharmazz.com

Ravi Kant

CONTACT

ravi.kant@pharmazz.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In PMZ group, 3 doses of PMZ-1620, 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 10, 2019
• First Posted: August 13, 2019
• Study Start: January 10, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (5)