Sovateltide for Stroke

(RESPECT-ETB Trial)

Recruiting at 5 trial locations

Overseen By Neil Marwah, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Pharmazz, Inc.

Disqualifiers: Comatose, Intracranial hemorrhage, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 1 week

514 Participants Needed

Trial Summary

What is the purpose of this trial?

Extensive research is being conducted in search of neuroprotective agents for possible use in the acute phase of stroke and agents that can be used for neurorepair in later stages of stroke. Several trials have been conducted and are in progress using different pharmacological agents, but none of the studies involve the stimulation of ETB receptors to treat cerebral ischemic stroke. Sovateltide (IRL-1620, PMZ-1620) has been effective in animal models of cerebral ischemic stroke. Its safety and tolerability have been demonstrated in a human phase I study with 7 subjects. Clinical phase II and III results indicate that sovateltide is a novel, first-in-class, highly effective drug candidate for treating cerebral ischemic stroke. Safety and significant efficacy in improving the National Institutes of Health Stroke Scale (NIHSS), Modified Rankin scale (mRS), and Barthel index (BI) obtained in phase II and III studies in patients with cerebral ischemic stroke in India are convincing and encouraged us to investigate its safety and efficacy in cerebral ischemic stroke patients in the United States. Therefore, the plan is to conduct a phase III clinical study to evaluate the safety and efficacy of sovateltide therapy along with standard of care in patients of acute ischemic stroke.

Research Team

Anil Gulati, MD, PhD

Principal Investigator

Pharmazz, Inc.

Eligibility Criteria

This trial is for adults aged 18-80 who've had a stroke confirmed by CT or MRI, presenting within 24 hours of symptom onset with moderate to severe impairment but still conscious. They must consent to the study and be available for follow-ups. Exclusion criteria are not specified here.

Inclusion Criteria

Patient or Legally Acceptable Representative (LAR) willing to give informed consent before study procedure

My stroke was caused by a clot and confirmed by a CT or MRI, with no bleeding in the brain.

I had a stroke within the last day and my stroke severity score is between 8 and 19.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive sovateltide or placebo along with standard of care. Three doses are administered as an IV bolus over one minute every 3 hours on day 1, repeated on days 3 and 6 post-randomization.

1 week

3 visits (in-person) on days 1, 3, and 6

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at days 30, 60, and 90 post-randomization.

12 weeks

3 visits (in-person) at days 30, 60, and 90

Treatment Details

Interventions

• Sovateltide

Trial Overview The trial tests Sovateltide's safety and effectiveness in acute ischemic stroke patients alongside standard care. It follows previous promising results from earlier phases showing improvements in stroke scales and functional outcomes.

Participant Groups

Group I: Sovateltide + Standard of care Experimental Treatment 1 Intervention

The test product is sovateltide. It is available as a lyophilized injection containing 30 µg of sovateltide in a 5.0 mL vial. Three doses of 0.3 μg/kg will be administered as an IV bolus over one minute every 3 hours ± 1 hour on day 1. The dose will be repeated on days 3 and 6 post randomization. The study drug will be administered as an IV bolus dose over 1 minute within 24 hours of the stroke onset.

Group II: Normal Saline + Standard of care Active Control 1 Intervention

Normal saline will be used as a comparator. It will be available in a 5.0 mL vial. Three doses will be administered as an IV bolus over one minute every 3 hours ± 1 hour on day 1. The dose will be repeated on days 3 and 6 post randomization. The study drug will be administered as an IV bolus dose over 1 minute within 24 hours of the stroke onset.

Who Is Running the Clinical Trial?

Pharmazz, Inc.

Lead Sponsor

Trials

13

Recruited

2,100+