ACST - Acasti Announces Poster Detailing its GTX-104 STRIVE-ON Trial | Benzinga
PRINCETON, N.J., Feb. 01, 2024 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (NASDAQ:ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that a poster outlining its pivotal Phase 3 STRIVE-ON safety trial (the STRIVE-ON trial–NCT05995405) has been accepted for presentation at the 2024 International Stroke Conference, to be held February 7-9, 2024 in Phoenix, AZ.
The poster, Safety and Tolerability of Intravenous Versus Enteral Nimodipine in Patients with Aneurysmal Subarachnoid Hemorrhage, will be presented Thursday February 8th during the Ongoing Clinical Trials session of the conference.
The STRIVE-ON trial is a prospective, open-label, randomized (1:1 ratio), parallel group trial of GTX-104 compared with oral nimodipine, in patients hospitalized for aSAH. Key trial design features include:
- Approximately 100 patients are expected to be enrolled at an estimated 25 hospitals in the U.S.
- The primary endpoint is safety and will be measured as comparative adverse events, including hypotension, between the two groups.
- GTX-104 will be administered as a continuous IV infusion of 0.15 mg/hour, and a 30-minute IV bolus of 4 mg every 4 hours. Oral nimodipine will be administered as 60 mg (two 30 mg capsules) every 4 hours.
- 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.
About aneurysmal Subarachnoid Hemorrhage (aSAH)
aSAH 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. A primary cause of such bleeding is the rupture of an aneurysm. Approximately 70% of aSAH patients experience death or dependence, and more than 30% die within one month of hemorrhage. Approximately 50,000 patients in the United States are affected by aSAH per year, based on market ...