Grace Therapeutics' GTx-104 Shows Positive Results in Phase 3 STRIVE-ON Trial

Grace Therapeutics announced that its Phase 3 STRIVE-ON trial evaluating GTx-104, an IV formulation of nimodipine for aneurysmal Subarachnoid Hemorrhage (aSAH), met its primary endpoint. The study demonstrated a 19% reduction in clinically significant hypotension compared to oral nimodipine, with additional benefits such as improved patient outcomes and fewer ICU readmissions. CEO Prashant Kohli highlighted the trial's success, emphasizing GTx-104’s potential to address a decades-long gap in aSAH treatment. The company plans to submit its New Drug Application (NDA) to the FDA in the first half of the year.

Dr. Loch MacDonald, Chief Medical Officer, noted that while STRIVE-ON wasn’t designed to prove efficacy, the results indicate meaningful improvements in patient care. The intravenous formulation allowed for higher doses of nimodipine with fewer side effects, leading to better treatment adherence and reduced hospitalization burdens. Experts believe GTx-104 could provide a long-awaited breakthrough in aSAH care, pending FDA approval.