Acasti Announces Dosing of First Patient in GTX-104 STRIVE-ON Trial

• With achievement of enrollment milestone, pivotal STRIVE-ON safety trial on track for potential NDA submission anticipated to occur in the first half of calendar 2025
• Recently announced $7.5 million private placement financing extends projected cash runway to the first calendar quarter of 2026

PRINCETON, N.J., Oct. 23, 2023 (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 enrollment of the first patient in the Company’s pivotal Phase 3 STRIVE-ON safety trial (the STRIVE-ON trial–NCT05995405). UTHealth Houston is the first site to enroll an aSAH patient in the STRIVE-ON trial.

“The dosing of our first patient in the STRIVE-ON trial is a significant milestone for Acasti, demonstrating our ability to execute our clinical development program for GTX-104,” said Prashant Kohli, CEO of Acasti. “We’re pleased to be working with a prestigious neurocritical care team such as UTHealth Houston, and look forward to welcoming additional centers. After the completion of our recently announced $7.5 million private placement offering, we have the balance sheet strength and are well positioned to continue GTX-104 development towards realizing its clinical and commercial prospects as a potential new treatment standard for aSAH.”

The Company previously announced alignment with the U.S. Food and Drug Administration (FDA) on the protocol and dosing regimen for the STRIVE-ON trial, at which time the FDA provided guidance regarding a potential New Drug Application (NDA) submission for GTX-104, currently anticipated in the first half of calendar 2025. GTX-104 has already been administered in over 160 healthy subjects in prior Phase 1 trials and has a well-established safety profile. GTX-104 has the potential to disrupt the oral nimodipine dosage form and become the standard of care in aSAH patients addressing critical unmet medical needs.

Acasti also recently hosted a virtual key opinion leader event featuring W. Taylor Kimberly, MD, PhD (Massachusetts General Hospital) who discussed the high unmet medical need and current treatment landscape for patients suffering from aSAH.

A replay of the webinar is available here.

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 research.