Acasti Reaches 50% Enrollment in Phase 3 STRIVE-ON Safety Trial

Acasti Pharma Inc., a biopharma company specializing in late-stage drug development, has announced significant progress in its pivotal Phase 3 STRIVE-ON safety trial for GTX-104. GTX-104 is an innovative injectable formulation of nimodipine designed to address the high unmet medical needs of patients suffering from aneurysmal subarachnoid hemorrhage (aSAH). The company confirmed that patient enrollment in the trial has surpassed the 50% mark.

The STRIVE-ON trial is a prospective, open-label, randomized study comparing GTX-104 with oral nimodipine in a cohort of 100 patients hospitalized for aSAH. Patient enrollment began in October 2023. The primary endpoint of the trial is to evaluate safety by comparing adverse events like hypotension between the two groups.

CEO of Acasti, Prashant Kohli, expressed his satisfaction with the trial's progress. “Since dosing the first patient in STRIVE-ON last October, we have continued to build momentum by activating high-volume neurocritical care hospitals across the country with unrelenting focus on executing patient enrollment and investigator engagement. Achievement of our 50% enrollment milestone reflects laser-sharp focus from both our participating clinical trial sites and the Acasti team,” he said. Kohli added that investigators are enthusiastic about GTX-104's potential as an IV alternative to oral nimodipine for aSAH treatment. Based on current projections, the company anticipates completing patient enrollment between late 2024 and early 2025, with a potential New Drug Application (NDA) submission to the FDA in the first half of 2025.

Dr. Abhishek Ray, Associate Professor of Neurological Surgery at University Hospitals Cleveland and Case Western Reserve University School of Medicine, noted the challenges in administering oral nimodipine to aSAH patients, who often present severe complications. “GTX-104 shows great promise as an IV alternative to the current standard of care, and we look forward to assessing the data obtained from this trial,” Dr. Ray stated.

Aneurysmal subarachnoid hemorrhage (aSAH) is a serious condition where bleeding occurs in the subarachnoid space, often due to a ruptured aneurysm. The prognosis is grim, with about 70% of patients either dying or becoming dependent, and more than 30% dying within a month of the hemorrhage. Annually, approximately 50,000 people in the United States suffer from aSAH, while the European Union and China report around 60,000 and 150,000 cases, respectively.

GTX-104 is a novel injectable formulation of nimodipine created for intravenous infusion in aSAH patients. The drug's unique nanoparticle technology allows for an aqueous formulation of the otherwise insoluble nimodipine, making it suitable for standard peripheral IV infusion. This innovation offers a convenient IV delivery method, potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients and reducing the risk of dosing errors, food effects, and drug-to-drug interactions.

GTX-104 has shown promising results in over 150 healthy volunteers, demonstrating good tolerance and significantly lower pharmacokinetic variability compared to oral nimodipine. The addressable market for GTX-104 in the United States is estimated to be about $300 million.

Acasti Pharma is focused on developing drug candidates for rare and orphan diseases. The company's novel drug delivery technologies aim to enhance the efficacy, reduce side effects, and offer more convenient delivery of existing medications. Acasti's key clinical assets, including GTX-104, have been granted Orphan Drug Designation by the FDA, providing seven years of market exclusivity post-launch in the United States along with additional intellectual property protection.