Acasti Pharma (NASDAQ:ACST) announces the initiation of its planned pharmacokinetic (PK) bridging study to evaluate the relative bioavailability of intravenous (IV) GTX-104 compared to currently marketed oral nimodipine capsules in 50 healthy subjects.
The PK study is the next required step in the proposed 505b2 regulatory pathway for GTX-104.
Results from the study are expected in the first half of 2022, and after review with the U.S. FDA, will help to determine the final design of the company’s planned Phase 3 safety study for GTX-104 in Subarachnoid Hemorrhage (SAH) patients.
The company expects to begin the Phase 3 study during the second half of 2022.
SAH is bleeding over the surface of the brain in the subarachnoid space between the brain and the skull, which contains blood vessels that supply the brain.