Core Insights - Grace Therapeutics, Inc. announced that the abstract of its Pivotal Phase 3 STRIVE-ON Safety Trial for GTx-104 has been accepted for late-breaking presentation at the Society of Vascular and Interventional Neurology annual meeting [1][2] Company Overview - Grace Therapeutics is a late-stage biopharma company focused on developing drug candidates for rare and orphan diseases, with a lead clinical asset, GTx-104, targeting aneurysmal subarachnoid hemorrhage (aSAH) [5] - The company utilizes novel drug delivery technologies aimed at improving the performance of existing drugs, achieving faster onset of action, enhanced efficacy, and reduced side effects [5] Product Details - GTx-104 is a clinical-stage injectable formulation of nimodipine designed for IV infusion in aSAH patients, addressing significant unmet medical needs [4] - The unique nanoparticle technology of GTx-104 allows for an aqueous formulation of insoluble nimodipine, facilitating standard peripheral IV infusion [4] - GTx-104 has been administered to over 200 patients and healthy volunteers, demonstrating good tolerance and significantly lower pharmacokinetic variability compared to oral nimodipine [4] Clinical Trial Information - The STRIVE-ON trial (NCT05995405) focuses on the safety and tolerability of GTx-104 compared to oral nimodipine in patients with aSAH [3] - The oral presentation of the trial results is scheduled for November 21, 2025, at the SVIN annual meeting [2][3] Market Context - Aneurysmal subarachnoid hemorrhage (aSAH) accounts for approximately 5% of all strokes, with an estimated 42,500 hospital-treated patients in the U.S. annually [3]

Summary of Grace Therapeutics KOL Event on GTX-one 104 Company Overview - **Company Name**: Grace Therapeutics (formerly Acasti) [4][3] - **Product Focus**: GTX-one 104, a novel injectable formulation of nimodipine, in late-stage clinical development [3][4] Industry Context - **Target Indication**: Aneurysmal subarachnoid hemorrhage (ASAH) [4] - **Current Treatment Landscape**: Nimodipine is the only FDA-approved drug for neuroprotection in ASAH, available only in oral formulations [16][24] Key Points Discussed Clinical Development and Trials - **Pivotal Phase III Trial**: The STRIGON trial for GTX-one 104 was fully enrolled in September 2024, with data readout expected in Q1 2025 [4] - **Market Opportunity**: GTX-one 104 aims to address significant unmet needs in ASAH treatment, particularly due to limitations of current oral formulations [4][24] Disease Overview - **Prevalence and Impact**: Approximately 2% to 8% of the population has aneurysms, with a global incidence of ASAH around 6 per 100,000 person-years [9][10] - **Mortality Rates**: Pre-hospital mortality for aneurysm rupture is between 22% and 26%, with an additional 20% mortality for those reaching the hospital [11] Challenges with Current Treatment - **Limitations of Oral Nimodipine**: - Requires frequent dosing (60 mg every 4 hours) which can lead to hypotension in 25% of patients [32][30] - Many patients (30%) present with dysphagia, complicating oral administration [33] - Gastrointestinal intolerance affects up to 80% of patients, leading to complications like diarrhea [35] - Less than half of patients receive the full 21-day course, impacting outcomes [36] Advantages of GTX-one 104 - **Intravenous Formulation Benefits**: - Provides guaranteed drug exposure and allows for titratable dosing, addressing hypotension and absorption issues [42][39] - Flexibility in administration, especially for patients unable to take oral medications [40][42] - Consistent bioavailability, reducing variability in patient response [62] Clinical Implications - **Potential for Improved Outcomes**: Consistent exposure to nimodipine is linked to better functional outcomes, particularly in patients with higher-grade ASAH [39][45] - **Integration into Clinical Practice**: The introduction of GTX-one 104 could enhance treatment protocols in neurocritical care settings, where titratable IV medications are preferred [56][57] Additional Considerations - **Regulatory Pathway**: Approval of GTX-one 104 will require a review process by pharmacy and therapeutics committees, assessing clinical benefits and cost-effectiveness [43][44] - **Future Research**: Comparative studies may be necessary to establish the efficacy of GTX-one 104 against existing treatments [52][54] Conclusion - **Strategic Importance**: GTX-one 104 represents a significant advancement in the treatment of ASAH, addressing critical limitations of current therapies and potentially improving patient outcomes in a high-mortality condition [45][46]