Acasti Pharma's IV Hemorrhage Drug Candidate At Par With Oral Nimodipine

Acasti Pharma Inc's ACST pharmacokinetic (PK) bridging study with IV GTX-104, its lead drug candidate for Subarachnoid Hemorrhage (SAH), met all its planned study endpoints.
The study's primary objective was to evaluate the relative bioavailability of IV GTX-104 compared to oral nimodipine in healthy subjects, while the secondary objective was to assess its safety and tolerability.
The company plans to submit these results to the FDA and its proposed study design for the Phase 3 safety study, which is on track to start in 2H of 2022.
Also See: Acasti Pharma's Hemorrhage Candidate Shows Encouraging PK Profile In Healthy Volunteers.
All three endpoints indicated that statistically, there was no difference in exposures between IV GTX-104 and oral nimodipine over the defined periods for maximum and total exposure.
Plasma concentrations obtained following IV administration showed significantly less variability between subjects than capsules.
Less than one-tenth of nimodipine is delivered with GTX-104 to achieve the same blood levels as the oral capsules.
No serious adverse events (AEs) and no AEs leading to withdrawal were reported.
Acasti also held $43.7 million in cash balance.
Price Action: ACST shares are down 4.98% at $0.92 during the market session on the last check Wednesday.