Core Insights - Grace Therapeutics, Inc. presented data from its Pivotal Phase 3 STRIVE-ON Safety Trial for GTx-104, an injectable formulation of nimodipine, at the Neurocritical Care Society annual meeting, highlighting its potential benefits over oral nimodipine in treating aneurysmal subarachnoid hemorrhage (aSAH) [1][2][3] Company Overview - Grace Therapeutics is a late-stage biopharma company focused on developing innovative drug delivery technologies for rare and orphan diseases, with GTx-104 as its lead clinical asset targeting aSAH [8] - The company has received Orphan Drug Designation from the FDA for its lead clinical assets, providing seven years of marketing exclusivity post-launch in the U.S. [8] Clinical Trial Results - The STRIVE-ON trial involved 50 patients receiving GTx-104 and 52 patients receiving oral nimodipine, with the primary endpoint being the incidence of clinically significant hypotension [3] - Results indicated that GTx-104 may deliver neuroprotective effects while reducing hypotensive events compared to oral nimodipine, along with improvements in ICU length of stay and reduced need for mechanical ventilation [3] Market Potential - The standard of care for aSAH has not seen significant innovation in nearly 40 years, positioning GTx-104 as a promising alternative if approved by the FDA [3] - The FDA's review of the New Drug Application (NDA) for GTx-104 is ongoing, with a target date of April 23, 2026 [3] Product Details - GTx-104 utilizes unique nanoparticle technology to facilitate the intravenous infusion of nimodipine, potentially improving patient management in the ICU and reducing complications associated with oral administration [5][6] - The product has been administered to over 200 patients and healthy volunteers, demonstrating good tolerability and lower pharmacokinetic variability compared to oral nimodipine [6]
Grace Therapeutics Pivotal Phase 3 STRIVE-ON Safety Trial Presented at 2025 Neurocritical Care Annual Meeting