Grace Therapeutics granted new patent for GTx-104 dosing regimen

Grace Therapeutics has received a new US patent (No. 12,414,943) titled "Nimodipine Parenteral Administration" from the US Patent and Trademark Office. The patent covers the dosing regimen for IV administration of nimodipine used in the Phase 3 STRIVE-ON safety trial for GTx-104, a clinical-stage treatment for subarachnoid hemorrhage patients. This adds to the company's multi-layered intellectual property estate, extending patent coverage to 2043.

Grace Therapeutics (NASDAQ: GRCE) has received a significant intellectual property milestone with the grant of its sixth U.S. patent (No. 12,414,943) for GTx-104, its injectable nimodipine formulation targeting aneurysmal subarachnoid hemorrhage (aSAH). The patent, titled "Nimodipine Parental Administration," covers the specific IV dosing regimen used in the company's Phase 3 STRIVE-ON safety trial. This new patent extends the company's patent protection until 2043, complementing its existing five patents on composition that provide protection until 2037.

The STRIVE-ON safety trial (NCT05995405) demonstrated that GTx-104, administered intravenously, reduced clinically significant hypotension by 19% compared to oral nimodipine. The trial also showed better relative dose intensity, fewer ICU readmissions, and improved functional outcomes at 90 days for patients receiving GTx-104 Grace Therapeutics Secures 6th Patent for GTx-104 IV ...^[1].

Grace Therapeutics has established a multi-layered intellectual property estate for GTx-104, including patents on both the composition and the method of administration. The company has also been granted Orphan Drug Designation from the FDA, providing seven years of marketing exclusivity upon FDA approval of the New Drug Application (NDA) Grace Therapeutics Secures 6th Patent for GTx-104 IV ...^[1].

The new method-of-use patent strengthens Grace Therapeutics' intellectual property position and extends its exclusivity window to 2043. This extended timeline significantly enhances the commercial potential of GTx-104, assuming FDA approval, by nearly ensuring almost two decades of market exclusivity. This is a remarkably long runway for generating returns in the pharmaceutical industry.