Pharma Focus Europe

Acasti Partners With Wuxi Clinical as CRO for STRIVE-ON Pivotal Phase 3 Safety Trial of GTX-104 in aSAH Patients

Tuesday, July 11, 2023

Acasti Pharma Inc. (Nasdaq: ACST) has announced its partnership with WuXi Clinical Development, Inc., a subsidiary of WuXi AppTec, to conduct the Phase 3 safety trial for GTX-104, an injectable nimodipine formulation developed by Acasti. The trial aims to address the high unmet medical needs for aneurysmal subarachnoid hemorrhage (aSAH), a rare disease. WuXi Clinical, a global Contract Research Organization (CRO) with experience in rare diseases, is well-suited to assist Acasti in conducting the STRIVE-ON trial.

STRIVE-ON (Safety, Tolerability, Randomized, IV and Oral Nimodipine) is a prospective, open-label, randomized trial that will compare the safety and tolerability profiles of GTX-104 and oral nimodipine in hospitalized patients with aSAH. The trial is expected to enroll approximately 100 patients across 25 hospitals in the United States. The primary endpoint will be the evaluation of comparative adverse events, including hypotension, between the two treatment groups.

Acasti has been collaborating with WuXi Clinical in preparation for the Phase 3 trial of GTX-104, aligning with the U.S. Food and Drug Administration (FDA) on the trial protocol and receiving guidance for a potential New Drug Application (NDA) package. Acasti plans to initiate patient dosing in the fourth quarter of 2023 and anticipates submitting an NDA in the first half of 2025.

WuXi Clinical Development, a subsidiary of WuXi AppTec, is a leading CRO providing comprehensive clinical development services. Their expertise spans various therapeutic areas, enabling them to accelerate clinical projects from early stages to marketed drugs and devices.

Aneurysmal subarachnoid hemorrhage (aSAH) refers to bleeding on the surface of the brain in the subarachnoid space, often caused by the rupture of an aneurysm. This condition is associated with high mortality and dependence rates, affecting around 50,000 patients in the United States annually.

GTX-104 is a clinical-stage injectable nimodipine formulation designed for intravenous infusion in aSAH patients. It addresses the significant unmet medical needs of this patient population. GTX-104 offers advantages such as convenient administration in the intensive care unit, potential elimination of nasogastric tube administration, reduced food effects and drug interactions, elimination of dosing errors, and improved management of hypotension. Previous studies in healthy volunteers have demonstrated the tolerability of GTX-104, showcasing its potential in the estimated $300 million market in the United States.

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