Acasti Announces Achievement of 50% Enrollment in Pivotal Phase 3 STRIVE-ON Safety Trial

Core Viewpoint - Acasti Pharma Inc. has announced that its pivotal Phase 3 STRIVE-ON safety trial for GTX-104 has surpassed the 50% enrollment milestone, indicating strong progress in addressing the unmet medical needs for aneurysmal subarachnoid hemorrhage (aSAH) [1][2] Company Overview - Acasti is a late-stage biopharma company focused on developing drug candidates for rare and orphan diseases, with GTX-104 being its lead clinical asset targeting aSAH [6] - The company utilizes novel drug delivery technologies aimed at improving the performance of existing medications, achieving faster onset of action, enhanced efficacy, and reduced side effects [6] GTX-104 Development - GTX-104 is a novel injectable formulation of nimodipine designed for intravenous infusion in aSAH patients, addressing significant unmet medical needs [4][5] - The drug aims to provide a convenient IV delivery method, potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients, and has shown promise in managing hypotension [5] Clinical Trial Progress - The STRIVE-ON trial is a randomized, open-label study comparing GTX-104 with oral nimodipine in 100 hospitalized aSAH patients, with safety as the primary endpoint [1][2] - Patient enrollment began in October 2023, and the company anticipates completing the randomization of all patients by late 2024 to early 2025, with a potential NDA submission to the FDA in the first half of 2025 [2] Market Potential - The addressable market for GTX-104 in the United States is estimated to be approximately $300 million, based on market research [5] - Aneurysmal subarachnoid hemorrhage affects around 50,000 patients annually in the U.S., with significant mortality and dependency rates [3]