Abstract
Background and aims
Sovateltide is being developed as a first-in-class drug for acute ischemic stroke (AIS). It is an endothelin-B receptor agonist and has shown anti-apoptotic, angiogenic, and neurogenic properties. It received approval for marketing in India in 2023. A global Phase III trial (RESPECT-ETB) is underway to evaluate its safety and efficacy.
Methods
Present the details of the RESPECT-ETB protocol, a pivotal study of sovateltide for the treatment of AIS.
Results
RESPECT-ETB is a randomized (1:1), double-blind, placebo-controlled trial being conducted in the USA, Germany, Spain, Australia, and the UK. It has received a Special Protocol Assessment agreement from the USFDA. Key inclusion criteria are adults (18–80 years) with AIS onset within 24 hours, NIHSS ≥8 and <20, NIHSS 1A <2, and pre-stroke mRS 0–2. Exclusions include intracranial hemorrhage, endovascular therapy, coma, pregnancy/lactation, and life-threatening comorbidities. Patients to receive an IV bolus dose of sovateltide/placebo (0.3 μg/kg) three times daily on days 1, 3, and 6.
Conclusions
The proportion of patients achieving an mRS score of 0–2 at day 90 is the primary endpoint; secondary endpoints include the proportion of patients with NIHSS 0-5, BI 90-100 on day 90 post-randomization. Stratification is by stroke onset time (<12 vs. ≥12 hours) and thrombolytic use. The proportion of patients with recurrent stroke, mortality, and intracranial hemorrhage within 90 days will be determined.