Pharmazz Presents Positive Phase IV Interim Analysis of Sovateltide for Acute Ischemic Stroke at the International Stroke Conference 2026

WILLOWBROOK, Ill., Feb. 04, 2026 (GLOBE NEWSWIRE) -- Pharmazz, Inc. today announced the presentation of positive interim results from its ongoing Phase IV clinical study of sovateltide (Tycamzzi®) in patients with acute cerebral ischemic stroke at the International Stroke Conference (ISC) 2026 in New Orleans.

The Phase IV study (NCT05955326) is a multicenter, randomized, controlled trial being conducted in India to further evaluate the real-world safety and effectiveness of sovateltide, a first-in-class, highly selective endothelin-B (ET-B) receptor agonist, when administered within 24 hours of stroke onset.

Key Findings from the Prespecified Interim Analysis
The interim analysis included 80 patients (39 sovateltide; 41 control) who completed 90-day follow-up assessments. Results demonstrated a clinically and statistically significant improvement in functional outcomes among patients treated with sovateltide:

• 92.3% of sovateltide-treated patients achieved a modified Rankin Scale (mRS) score of 0–2 at Day 90, compared with 58.5% in the control group (Odds Ratio 8.50; 95% CI 2.44–29.01; p=0.0005)
• An absolute 33% increase in favorable functional outcomes (mRS 0–2) was observed with sovateltide treatment
• 84.6% of sovateltide-treated patients achieved an improvement of ≥2 points on the mRS, compared with 51.2% in controls (p=0.0014)
• Baseline characteristics, including age, NIHSS score, and time from stroke onset to treatment, were comparable between groups
• No drug-related adverse events were observed, and safety outcomes were consistent with prior studies

Study Design
Patients aged 18–78 years with radiologically confirmed ischemic stroke and NIHSS ≥6 were randomized to receive either sovateltide (0.3 µg/kg) or saline placebo. The study drug was administered as three intravenous bolus doses over one minute at 3±1 hour intervals on Days 1, 3, and 6. Outcomes were assessed at Day 90 using the modified Rankin Scale.

About Sovateltide
Sovateltide is approved for marketing in India and was launched in September 2023. To date, over 100,000 patients have been treated. The drug has demonstrated neuroprotective, pro-angiogenic, and neurogenic effects across preclinical and clinical studies, with a favorable safety profile.

A global Phase III randomized, double-blind, placebo-controlled trial (RESPECT-ETB; NCT05691244) is currently underway across the United States, Europe, the United Kingdom, and Australia, evaluating sovateltide in more than 500 patients with acute ischemic stroke.

About Pharmazz
Pharmazz, Inc. is a biopharmaceutical company focused on developing novel therapies for critical care and neurological disorders. Its lead programs target conditions with high unmet medical need, including acute ischemic stroke and hypovolemic shock.

Contact Information:
Investors 
Kabir Marwah 
Tel +1 630 780 6087 
Email kabir.marwah@pharmazz.com

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