Pharmazz Completes Phase 4 Study for Sovateltide in Acute Ischemic Stroke

WILLOWBROOK, Ill., Sept. 28, 2026 /CourierPR/ -- Pharmazz, Inc., a biopharmaceutical company focused on developing novel therapeutics for critical care and neurovascular conditions, has completed enrollment in a 160-patient Phase 4 clinical study of sovateltide (Tycamzzi®) for the treatment of acute ischemic stroke. The study, a post-approval commitment required by Indian regulators, is part of the company's ongoing efforts to address the significant unmet medical needs in this condition.

The double-blind, placebo-controlled Phase 4 study (NCT05955326) follows the same dosing regimen, randomization, and 24-hour treatment window as the global Phase 3 RESPECT-ETB trial. Key secondary endpoints include Day 90 neurological recovery, functional independence, and disability using the National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), and the Barthel Index. Final data from the study are expected in Q1 2027.

In September 2025, Pharmazz conducted a prespecified interim analysis of the first 80 patients who reached the Day 90 endpoint. The analysis revealed that 92% of sovateltide-treated patients achieved an mRS score of 0 to 2 at Day 90, compared to 58% in the control arm (p=0.0004889). Notably, no drug-related adverse events were observed. This interim analysis was presented at the International Stroke Conference 2026 in New Orleans.

Sovateltide (IRL-1620) is a first-in-class endothelin-B receptor agonist that promotes neurogenesis, angiogenesis, and neuronal survival following acute hypoxic and ischemic insults. The drug has been used to treat more than 140,000 patients in India since its launch, providing empirical real-world evidence of its efficacy. The Phase 3 RESPECT-ETB trial, currently enrolling patients at 57 sites in the US, Germany, Spain, and the UK, is designed to enroll 514 stroke patients and remains on track for topline data in early 2028.

Pharmazz will present five sovateltide abstracts at the 18th World Stroke Congress, taking place October 21-23, 2026, in Seoul, South Korea. The presentations will cover various aspects of the drug's effectiveness and safety, including its impact on thrombolytic activity and its role in promoting neurological recovery.

The FDA granted Orphan Drug Designation to sovateltide for the treatment of neonatal hypoxic-ischemic encephalopathy in September 2026. This designation qualifies the sponsor for specific development incentives under the Orphan Drug Act, including tax credits for qualified clinical testing and potential eligibility for seven years of market exclusivity in the U.S. upon regulatory approval.

Pharmazz's commitment to addressing severe neurovascular conditions with high unmet medical needs is underscored by the completion of this Phase 4 study. The company's ongoing efforts in clinical trials and the positive interim results from the Phase 4 study provide hope for improved treatment options for patients suffering from acute ischemic stroke.