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.
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