Pharmazz Completes Enrollment in 160-Patient Phase 4 Trial of Sovateltide in Acute Ischemic Stroke

• Enrollment completed in the double-blind, placebo-controlled Phase 4 study (NCT05955326) of sovateltide (Tycamzzi®), with final study data expected in Q1 2027
• Five sovateltide abstracts accepted at World Stroke Congress, October 21-23, 2026, Seoul, South Korea, including an interim analysis of the Phase 4 trial
• Global Phase 3 RESPECT-ETB trial (NCT05691244) actively enrolling and remains on track for topline data in early 2028
  

WILLOWBROOK, Ill., Sept. 28, 2026 (GLOBE NEWSWIRE) -- Pharmazz, Inc. ("Pharmazz" or the "Company"), a biopharmaceutical company developing novel therapeutics for critical care and neurovascular conditions, today announced that enrollment is complete in its 160-patient Phase 4 clinical study of sovateltide (Tycamzzi®) in patients with acute cerebral ischemic stroke in India.

The Phase 4 study (NCT05955326) is a post-approval commitment required by Indian regulators. The double-blind, placebo-controlled trial utilizes the same sovateltide dosing regimen, randomization, and 24-hour treatment window as the global Phase 3 RESPECT-ETB trial, and the same protocol and eligibility criteria as the Phase 3 study that supported approval in India. The primary endpoint is the proportion of patients with adverse events and serious adverse events. Key secondary endpoints measure 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 are expected in Q1 2027.

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

"Dosing the final patient in our Phase 4 study marks an important milestone in our mission to address severe neurovascular conditions with high unmet medical needs," said Dr. Anil Gulati, M.D., Ph.D., Chairman and Chief Executive Officer of Pharmazz, Inc. "Acute ischemic stroke remains a leading cause of long-term disability worldwide, and treatment options are limited. The fact that Sovateltide has been used to treat more than 140,000 patients in India since launch provides empirical real-world evidence that the selective endothelin B receptor agonist is able to promote neurogenesis, angiogenesis, and neuronal survival. We are actively enrolling in our global Phase 3 RESPECT-ETB trial and look forward to reporting final data in early 2028."

Upcoming Presentations at the 18^th World Stroke Congress

Five presentations will be made on-site at the upcoming 18^th World Stroke Congress, taking place October 21-23, 2026, at the Convention & Exhibition Center, Seoul, South Korea.

1. A meta-analysis assessing the effectiveness and safety of sovateltide in patients with acute ischemic stroke
2. A global Phase III trial (RESPECT-ETB) to evaluate safety and effectiveness of sovateltide (Tycamzzi®) in ACIS patients 
3. Effect of sovateltide (Tycamzzi®) on the thrombolytic activity of alteplase and tenecteplase
4. An interim analysis of multicentric, randomized Phase 4 clinical trial of sovateltide (Tycamzzi®) in AIS patients 
5. The development of sovateltide for cerebral ischemic stroke patients.
   

About Sovateltide

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 is currently being evaluated in clinical programs for acute ischemic conditions. The Phase 3 RESPECT-ETB (ClinicalTrials.gov ID: NCT05691244) trial is being conducted at 57 sites in the US, Germany, Spain, and the UK, and is designed to enroll 514 stroke patients. In September 2026, the U.S. FDA granted Orphan Drug Designation to sovateltide for the treatment of neonatal hypoxic-ischemic encephalopathy.

About Orphan Drug Designation

The FDA's Orphan Drug Designation program provides orphan status to investigational drugs and biological products intended to safely and effectively treat, diagnose, or prevent rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation qualifies the sponsor for specific development incentives under the Orphan Drug Act, which may include tax credits for qualified clinical testing, exemptions from prescription drug user fees (PDUFA), and potential eligibility for seven years of market exclusivity in the U.S. upon regulatory approval for the designated indication.

About Pharmazz, Inc.

Pharmazz, Inc. is a biopharmaceutical company focused on developing and commercializing first-in-class therapies for critical care medicine. For more information, please visit www.pharmazz.com.

Disclaimer:

Statements in this "Document" describing the Company's objectives, projections, estimates, expectations, plans or predictions, or industry conditions or events may be "forward-looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance, or achievements could differ materially from those expressed or implied. The Company undertakes no obligation to update or revise forward-looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof.

Contacts: Pharmazz, Inc.