Acasti Pharma's Hemorrhage Candidate Shows Encouraging PK Profile In Healthy Volunteers

Acasti Pharma Inc ACST has announced interim results from its pivotal pharmacokinetic (PK) bridging study of GTX-104 for Subarachnoid Hemorrhage.

• Based on an interim analysis of the first 20 of 50 normal healthy subjects, GTX-104 met both primary endpoints for Maximum Concentration (Cmax) on Day 1 and Area Under the Concentration-Time Curve (AUC 0-24 hours) on Day 3, allowing the study to continue under the current infusion protocol to its completion. 
• GTX-104 is an aqueous formulation of nimodipine developed as an IV infusion for patients experiencing Subarachnoid Hemorrhage or bleeding over the brain's surface triggered by a ruptured aneurysm.
• So far, there have been no serious adverse events observed, and only mild adverse events were reported in both groups, such as headaches that were resolved with common medications.
• The Company plans to report the final study results in 1H of 2022. 
• If the final study results are consistent with these interim results, the Company would quickly finalize the study design and protocol for the Phase 3 Safety Study of GTX-104 with the FDA and initiate the study in 2H of 2022.
• Price Action: ACST shares are up 0.79% at $1.28 during the premarket session on the last check Thursday.