Grace Therapeutics Granted Sixth U.S. Patent Covering I.V. Dosing Regimen for GTx-104

Core Viewpoint - Grace Therapeutics has received a new method of use patent for GTx-104, extending its intellectual property protection until 2043, which enhances the company's market exclusivity and potential value for shareholders [2][3][4]. Intellectual Property and Patent Protection - The U.S. Patent and Trademark Office issued U.S. Patent No. 12,414,943 for the dosing regimen of GTx-104, which is used in the Phase 3 STRIVE-ON safety trial [2]. - Grace Therapeutics has established a multi-layered intellectual property estate for GTx-104, including five patents on the composition of nimodipine, providing protection until 2037 [3]. - The new patent on the I.V. dosing regimen strengthens the company's intellectual property position and extends protection to 2043 [3]. Clinical Trial Insights - The STRIVE-ON safety trial involved 50 patients receiving GTx-104 and 52 patients receiving oral nimodipine, with GTx-104 showing a 19% reduction in clinically significant hypotension incidents compared to oral nimodipine (28% vs. 35%) [5]. - Patients receiving GTx-104 had a relative dose intensity (RDI) of 95% or higher in 54% of cases, compared to only 8% for oral nimodipine [5]. - GTx-104 demonstrated fewer ICU readmissions, ICU days, and ventilator days compared to oral nimodipine, with adverse events being comparable between both treatment arms [5]. Product Overview - GTx-104 is a novel injectable formulation of nimodipine developed for I.V. infusion in patients with aSAH, addressing significant unmet medical needs [7][9]. - The unique nanoparticle technology of GTx-104 allows for a standard peripheral I.V. infusion, potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients [8]. - GTx-104 has been administered to over 200 patients and healthy volunteers, showing well-tolerated results with lower pharmacokinetic variability compared to oral nimodipine [8]. Market Exclusivity - GTx-104 has received Orphan Drug Designation from the FDA, granting it seven years of marketing exclusivity in the U.S. upon FDA approval of the New Drug Application (NDA) [3][9].