Acasti says candidate for subarachnoid hemorrhage met main goals in pivotal PK study

• Acasti Pharma (NASDAQ:ACST) said that its pivotal pharmacokinetic (PK) bridging study for GTX-104 reached all primary endpoints based on an interim look at the data from the first 20 of 50 normal healthy subjects in the trial.
• Being developed as an IV infusion for patients with Subarachnoid Hemorrhage (SAH), GTX-104 is a version of nimodipine, the standard of care for the indication.
• The achievement of both primary endpoints for Maximum Concentration (Cmax) on Day 1 and Area Under the Concentration-Time Curve (AUC 0-24 hours) on Day 3 has allowed the trial to proceed till the end per the current infusion protocol, the company said.
• There were no serious adverse events, and the headaches were among the mild adverse events reported in the trial. Acasti Pharma (ACST) expects to disclose final study results during H1 2022 and plans to begin the Phase 3 Safety Study of GTX-104 in H2 2022.
• “Importantly, we believe the follow-up safety study has the potential to be relatively fast, low cost and low risk based on the favorable safety profile observed to date,” remarked Jan D’Alvise, Acasti’s CEO.
• Read more on some of the recent highlights of the company’s performance.