Acasti Pharma announces alignment with FDA on GTX-104 Phase 3 safety trial

Acasti Pharma announced that the Company has aligned with the U.S. Food and Drug Administration, FDA, on the protocol for its pivotal Phase 3 trial of GTX-104 and the FDA also provided guidance for a potential GTX-104 New Drug Application, NDA, package. Acasti has all the necessary information from the FDA to initiate its recently named STRIVE-ON pivotal Phase 3 trial of GTX-104 to evaluate its safety and tolerability profile relative to oral nimodipine. “We greatly appreciate FDA’s guidance on the STRIVE-ON trial design and are pleased with the agency’s confirmation that the proposed dosing regimen, which mirrors the one used in the pivotal PK bridging study GTX-104-002, appears reasonable,” commented Prashant Kohli, CEO of Acasti. “We are moving full speed ahead with anticipated first patient dosing in the fourth calendar quarter of this year and a potential NDA submission in the first half of calendar 2025. GTX-104 has a strong established safety profile having already been administered to over 150 healthy volunteers to-date. We look forward to the completion of the STRIVE-ON trial, and if approved by the FDA, GTX-104 could bring enhanced options for physicians treating patients suffering from aSAH.”