Acasti Announces Completion of Patient Enrollment in Pivotal Phase 3 STRIVE-ON Safety Trial of GTX-104

Core Viewpoint - Acasti Pharma Inc. has completed patient enrollment in its Phase 3 STRIVE-ON safety trial for GTX-104, a novel injectable formulation of nimodipine aimed at treating aneurysmal subarachnoid hemorrhage (aSAH), with data readout expected in early 2025 and plans for a New Drug Application submission to the FDA in the first half of next year [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 [8]. - The company has received Orphan Drug Designation from the FDA for its lead assets, providing seven years of marketing exclusivity post-launch in the U.S. [8]. Clinical Trial Details - The STRIVE-ON trial is a prospective, open-label, randomized trial comparing GTX-104 with oral nimodipine in 100 hospitalized aSAH patients across approximately 25 U.S. hospitals [1][2]. - The primary endpoint of the trial is safety, measured by comparative adverse events, including hypotension, between the two patient groups [2]. Market Potential - The addressable market for GTX-104 in the United States is estimated to be around $300 million based on market research [5]. - Approximately 50,000 patients in the U.S. are affected by aSAH annually, with an estimated 60,000 cases in the European Union and 150,000 in China [3]. Product Advantages - GTX-104 offers a convenient intravenous delivery method that may eliminate the need for nasogastric tube administration in unconscious or dysphagic patients, potentially reducing food effects, drug interactions, and dosing errors [5]. - The formulation has been well tolerated in over 150 healthy volunteers, showing significantly lower pharmacokinetic variability compared to oral nimodipine [5].