ACST - Acasti says pharmacokinetic trial for lead asset met all study goals

Announcing topline data from a pharmacokinetic (PK) bridging study, the Canadian biopharma company Acasti Pharma (NASDAQ:ACST) said on Wednesday that its lead drug candidate, IV GTX-104, met all its planned study endpoints in Subarachnoid Hemorrhage (SAH). The single-site trial conducted in Canada involving healthy adults was designed to compare the relative bioavailability of oral nimodipine with GTX-104 as the primary objective. With GTX-104 being a novel intravenously delivered formulation of nimodipine, the safety, and tolerability of the drug were assessed as the secondary endpoint. According to the company, the bioavailability of oral nimodipine was only 8% compared to IV GTX-104. There were no reports of serious adverse events (AEs) and AEs leading to withdrawals during the study, Acasti (ACST) added. The company plans to submit the data and its design for a future Phase 3 trial to the US Food and Drug Administration. Acasti (ACST) is on track to start

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Acasti says pharmacokinetic trial for lead asset met all study goals