Acasti Pharma Inc. has announced the completion of patient enrollment in its Phase 3 STRIVE-ON safety trial evaluating GTX-104, a novel injectable formulation of nimodipine, for the treatment of aneurysmal subarachnoid hemorrhage (aSAH). This milestone, achieved ahead of schedule, marks a significant step toward potentially transforming the standard of care for this life-threatening condition.
The STRIVE-ON trial (NCT05995405) is a prospective, open-label, randomized (1:1 ratio), parallel group trial comparing GTX-104 with oral nimodipine in 100 patients hospitalized for aSAH across approximately 25 hospitals in the U.S. The primary endpoint of the trial is safety, assessed by comparing adverse events, including hypotension, between the two treatment groups. Data readout from the STRIVE-ON trial is expected in early calendar 2025, with plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the first half of 2025.
Addressing Unmet Needs in aSAH Treatment
Aneurysmal subarachnoid hemorrhage (aSAH) is a critical condition involving bleeding over the surface of the brain, often due to a ruptured aneurysm. It carries a high mortality and morbidity rate, with approximately 70% of patients experiencing death or dependence, and over 30% dying within one month of the hemorrhage. In the United States, aSAH affects approximately 50,000 individuals annually.
Currently, oral nimodipine is a standard treatment for aSAH. However, its administration can be challenging, particularly in unconscious or dysphagic patients who may require nasogastric tube administration. GTX-104, utilizing a unique nanoparticle technology, offers a convenient intravenous (IV) delivery of nimodipine, potentially eliminating the need for nasogastric tubes and reducing the risk of dosing errors and drug-to-drug interactions. Furthermore, IV delivery may improve the management of hypotension in aSAH patients.
GTX-104: A Novel Approach to Nimodipine Delivery
GTX-104 is designed to address the limitations of oral nimodipine by providing a stable, aqueous formulation suitable for IV infusion. Preclinical and early clinical studies have demonstrated that GTX-104 is well-tolerated, with significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine. Acasti estimates the addressable market for GTX-104 in the United States to be approximately $300 million.
"We are excited to announce the completion of enrollment in our STRIVE-ON trial, a significant milestone for the Company achieved ahead of our original expectations," said Prashant Kohli, CEO of Acasti. "We believe that if approved, GTX-104 has the potential to address significant challenges with oral nimodipine administration and may transform the standard of care for patients with aSAH."
