Acasti Pharma Inc. has announced its alignment with the U.S. Food and Drug Administration (FDA) on the protocol for its pivotal Phase 3 trial of GTX-104, a novel injectable nimodipine formulation for intravenous infusion (IV), in patients hospitalized with aneurysmal subarachnoid hemorrhage (aSAH). The company also confirmed its planned initiation of the STRIVE-ON trial in aSAH patients in calendar Q4 2023.
The STRIVE-ON trial aims to evaluate the safety and tolerability profile of GTX-104 compared to oral nimodipine in approximately 100 patients hospitalized for aSAH. The primary endpoint will be measured as comparative adverse events, including hypotension, between the two groups. GTX-104 will be administered through continuous IV infusion and a 30-minute IV bolus, while oral nimodipine will be administered at regular intervals.
Acasti has received guidance from the FDA regarding a potential New Drug Application (NDA) package for GTX-104.