ABSTRACT NUMBER: ESOC2026LB19 AN INTERIM ANALYSIS OF THE MULTICENTRIC, RANDOMIZED PHASE 4 CLINICAL TRIAL OF SOVATELTIDE (TYCAMZZI®) IN ACUTE ISCHEMIC STROKE PATIENTS

Abstract Background and aims Sovateltide, an endothelin-B receptor agonist, has shown favorable functional outcomes in acute ischemic stroke (AIS) and is approved in India as a first-in-class therapy for AIS. A phase 4 study (NCT05955326) is currently recruiting patients in India (target N=160) to further assess safety and effectiveness. This report presents the results of a prespecified interim analysis conducted after enrollment of 80 patients. Methods Eligible participants were adults aged 18 to 78 years with radiologically confirmed AIS and an NIHSS score of 6 or higher, presenting within 24 hours of symptom onset. Exclusion criteria included intracranial hemorrhage and receipt of endovascular therapy. Participants were randomized to receive either normal saline or sovateltide (0.3 μg/kg), administered intravenously in three doses at 3±1 hour intervals on days 1, 3, and 6. Analyses were conducted in the intention-to-treat population, with missing endpoints imputed using MICE. Results Patient age and body weight, sex distribution, NIHSS score (p=0.5216), comorbidities, and the median time from symptom onset to first dose (16–18 hours) were comparable between groups. At 90 days, the sovateltide group (92.3%) of patients with mRS 0-2, showed greater improvement (OR 8.50, 95% CI 2.44-29.01; p=0.0005) than the control group (58.5%). Sovateltide group had more patients (84.62%) with improvement of ≥2 mRS points from baseline (Odds 5.24, 95% CI 1.85-15.50; p=0.0014) than control (51.22%). Ordinal shift analysis of mRS also favored sovateltide by 33% compared to control. Conclusions Sovateltide was associated with significantly improved 90-day functional outcomes, consistent with results from previous AIS efficacy trials. Conflict of interest