Grace Therapeutics reports positive results from pivotal Phase 3 STRIVE-ON Safety Trial.

Grace Therapeutics presented results from its Pivotal Phase 3 STRIVE-ON Safety Trial of GTx-104, a novel injectable formulation of nimodipine for I.V. infusion, at the Neurocritical Care Society annual meeting. The trial demonstrated safety and tolerability of GTx-104 compared to oral nimodipine in patients with aneurysmal subarachnoid hemorrhage.

Grace Therapeutics (NASDAQ: GRCE) presented results from its Pivotal Phase 3 STRIVE-ON Safety Trial of GTx-104, a novel injectable formulation of nimodipine for I.V. infusion, at the Neurocritical Care Society annual meeting. The trial demonstrated the safety and tolerability of GTx-104 compared to oral nimodipine in patients with aneurysmal subarachnoid hemorrhage (aSAH).

The STRIVE-ON trial enrolled 300 patients with aSAH, with 150 receiving GTx-104 and 150 receiving oral nimodipine. The primary endpoint was the incidence of adverse events, with secondary endpoints including clinical outcomes and safety markers. The results showed that GTx-104 was well-tolerated and demonstrated a favorable safety profile compared to oral nimodipine, with no significant differences in the incidence of adverse events between the two groups.

The trial also found that GTx-104 was associated with improved clinical outcomes, including reduced vasospasm and better neurological recovery compared to oral nimodipine. Additionally, GTx-104 was found to be more effective in reducing the risk of delayed cerebral ischemia, a major complication of aSAH.

The STRIVE-ON trial results further strengthen Grace Therapeutics' intellectual property position for GTx-104, which has been granted six U.S. patents, including a recently issued patent covering the I.V. dosing regimen used in the trial. This patent extends the company's exclusivity window to 2043, providing a strong multi-layered IP fortress for their lead asset.

Grace Therapeutics has also been granted Orphan Drug Designation from the FDA for GTx-104, which provides seven years of marketing exclusivity in the United States upon FDA approval of the company's New Drug Application (NDA). The company is currently preparing to submit its NDA for GTx-104 to the FDA.

The STRIVE-ON trial results, combined with the company's robust IP portfolio and FDA Orphan Drug Designation, position GTx-104 as a promising treatment option for aSAH patients. The results also highlight the potential for Grace Therapeutics to generate significant returns in the pharmaceutical industry, assuming FDA approval and market success.