By Robb M. Stewart


Acasti Pharma said Wednesday it has aligned with the U.S. Food and Drug Administration on the protocol for its late-stage trial of its lead clinical asset, GTX-104.

The Quebec-based biopharmaceutical company also said it has received guidance from the regulator on a potential new drug application package for a novel injectable nimodipine formulation administered under intravenous infusion.

Acasti said it has all the necessary information from the FDA to initiate its Phase 3 trial of GTX-104 to evaluate the drug candidate's safety and tolerability profile relative to oral nimodipine as a treatment for aneurysmal subarachnoid hemorrhage, a rare and life-threatening medical emergency.

Acasti said its expects to dose the first Phase 3 trial patient in the fourth quarter and its current cash runway to be sufficient in funding a potential new drug application submission for GTX-104 in the first half of 2025.


Write to Robb M. Stewart at robb.stewart@wsj.com


(END) Dow Jones Newswires

07-05-23 0937ET