Sovateltide for Stroke

(RESPECT-ETB Trial)

Recruiting at 36 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called sovateltide for individuals who have experienced an acute ischemic stroke. The goal is to evaluate the effectiveness and safety of sovateltide when administered alongside standard stroke care. Participants will receive either sovateltide or a saline solution for comparison, both within 24 hours of the stroke. The trial seeks individuals who have had a stroke caused by a blocked artery (ischemic stroke) without brain bleeding and who can begin treatment within 24 hours of stroke symptom onset. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor to get specific guidance.

Is there any evidence suggesting that sovateltide is likely to be safe for humans?

Research has shown that sovateltide is safe and well-tolerated in people. Earlier studies reported no safety concerns for patients who received sovateltide, and it did not increase cases of brain bleeding compared to those who did not receive it. Tests on patients with acute cerebral ischemic stroke found that sovateltide improved brain function 90 days after treatment without major safety issues. So far, the treatment appears promising and does not present significant safety risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard stroke treatments, which often involve clot-busting drugs like tPA (tissue plasminogen activator) and mechanical thrombectomy, sovateltide offers a novel approach. Sovateltide is unique because it targets the endothelin B receptor, which plays a crucial role in neuroprotection and neuroregeneration. This new mechanism of action could help protect brain cells and enhance recovery after a stroke. Additionally, sovateltide is administered as an IV bolus within 24 hours of stroke onset, potentially offering rapid intervention to limit brain damage. Researchers are excited about sovateltide because it represents a promising step forward in improving stroke outcomes beyond the current standard of care.

What evidence suggests that sovateltide might be an effective treatment for stroke?

Research has shown that sovateltide, which participants in this trial may receive, effectively treats strokes caused by reduced blood flow to the brain. Specifically, studies found that 72.5% of patients who received sovateltide improved by at least 2 points on a disability scale after a stroke, compared to 51.28% in the group without the treatment. Patients also scored better on a test assessing stroke symptom severity. Sovateltide is safe and well-tolerated, offering hope for better recovery after a stroke. ^{1 2 3 6 7}

Who Is on the Research Team?

Anil Gulati, MD, PhD

Principal Investigator

Pharmazz, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39542995/

Efficacy and Safety of Sovateltide in Patients with Acute ... An improvement of ≥ 2 points on the mRS was observed in 51.28% and 72.50% of patients in the control and sovateltide groups, respectively (OR ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05691244

Assess the Safety and Efficacy of Sovateltide in Patients ... Clinical phase II and III results indicate that sovateltide is a novel, first-in-class, highly effective drug candidate for treating cerebral ischemic stroke.

3. ahajournals.org ahajournals.org/doi/abs/10.1161/str.56.suppl_1.TP17

Abstract TP17: Discovery and development of sovateltide ... Pharmacologically targeting ET-B receptors with sovateltide is safe and effective in improving neurological outcomes in cerebral ischemic stroke patients.

4. journals.lww.com journals.lww.com/ccmjournal/fulltext/2021/01001/5__efficacy_of_sovateltide_in_patients_with_acute.8.aspx

5: Efficacy of Sovateltide in Patients With Acute Cerebral... Sovateltide was safe, well tolerated and resulted in improved neurological outcomes in acute cerebral ischemic stroke patients.

5. ammspub.com ammspub.com/index.php/amms/article/view/89

Sovateltide as a Game Changer for Small Strokes Primary outcomes included changes in the National Institutes of Health Stroke Scale (NIHSS) scores from baseline to 72 hours.

6. link.springer.com link.springer.com/article/10.1007/s40265-024-02121-5

Efficacy and Safety of Sovateltide in Patients with Acute ... No safety concerns were observed, and there was no increase in the rate of intracranial haemorrhage in the sovateltide group compared with the ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33428177/

Safety and Efficacy of Sovateltide (IRL-1620) in a ... Sovateltide was safe and well-tolerated and resulted in improved neurological outcomes in patients with acute cerebral ischemic stroke 90 days post-treatment.