The pivotal Phase 3 GTX-104 STRIVE-ON trial is a crucial step in evaluating the safety and efficacy for aSAH patients.
GTX-104 is a clinical-stage, injectable formulation of nimodipine. It is specifically designed to address the significant unmet medical needs of aSAH patients. With its nanoparticle technology, GTX-104 enables the aqueous formulation of insoluble nimodipine for intravenous infusion (IV). This approach offers several advantages over traditional oral nimodipine delivery, including:
- enhanced efficacy
- reduced side effects
- more convenient administration.
What is aSAH?
Aneurysmal subarachnoid hemorrhage is a life-threatening condition characterized by bleeding over the surface of the brain in the subarachnoid space. It occurs when an aneurysm ruptures, leading to significant morbidity and mortality. aSAH affects approximately 50,000 patients in the United States each year. Currently, there is a critical unmet medical need to improve the treatment options for aSAH patients.
The STRIVE-ON Trial
The pivotal Phase 3 STRIVE-ON safety trial is a crucial step in evaluating the safety and efficacy of GTX-104 for aSAH patients. Acasti announced the enrollment of the first patient in the trial, marking a significant milestone in the clinical development program for GTX-104. The trial protocol and dosing regimen have been aligned with the U.S. Food and Drug Administration (FDA), who provided guidance regarding a potential NDA submission for GTX-104 in the first half of calendar 2025.
GTX-104 has already been administered to over 160 healthy subjects in prior Phase 1 trials, establishing a well-established safety profile. This favorable safety profile instills confidence in the potential of GTX-104 to become the new treatment standard for aSAH.
Aneurysmal subarachnoid hemorrhage affects approximately 50,000 patients in the United States each year. With a significant portion of aSAH patients experiencing death or dependence, there is a critical need for improved treatment options. The addressable market in the United States for GTX-104 is estimated to be around $300 million, based on market research.
With its novel formulation of nimodipine and the successful enrollment of the first patient in the pivotal Phase 3 STRIVE-ON safety trial, Acasti is moving closer to potentially addressing the high unmet medical needs of aSAH patients. The advantages of GTX-104, along with its well-established safety profile, position it as a potential new treatment standard for aSAH, offering hope and improved outcomes for patients suffering from this life-threatening condition.
For more information on aneurysmal subarachnoid hemorrhage and other neurological diseases click here checkrare.com/diseases/neurology-nervous-system-diseases/
Reference