Acasti Pharma (NASDAQ:ACST) and the FDA agreed on the protocol of a Phase 3 trial of GTX-104 in patients with aneurysmal subarachnoid hemorrhage (aSAH), a rare disease with 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.
The FDA also provided guidance for a potential GTX-104 NDA package.
Acasti has all the necessary information from the FDA to initiate its recently named STRIVE-ON pivotal trial of GTX-104 to evaluate its safety and tolerability profile, relative to oral nimodipine.
“We are moving full speed ahead with anticipated first patient dosing in the fourth quarter this year and a potential NDA submission in the first half of 2025,” Prashant Kohli, CEO of Acasti, said in a statement.
The study is expected to enrol 100 patients at an estimated 25 hospitals in the U.S. that will be randomized 1:1 to evaluate GTX-104, compared with oral nimodipine, in patients hospitalized for aSAH.
The primary endpoint is safety and will be measured as comparative adverse events, including hypotension, between the two groups.
Both groups will receive their assigned GTX-104 or oral nimodipine for up to 21 consecutive days and will be evaluated from commencement of patient treatment through a 90-day follow-up period.
Mr. Kohli said the company believes that its current cash runway to be sufficient to achieve a potential NDA submission for GTX-104 in the first half of calendar 2025.
