Grace Therapeutics (Nasdaq: GRCE) unveiled encouraging data from its pivotal Phase III STRIVE-ON trial, showing that GTx-104, an intravenous (IV) nimodipine formulation, significantly lowers the risk of clinically significant hypotension in patients with aneurysmal subarachnoid hemorrhage (aSAH) compared to the standard oral formulation.

Key Findings from STRIVE-ON

• The primary endpoint—incidence of at least one clinically significant hypotensive episode—favored GTx-104. The IV group showed a 28% rate of hypotension, compared to 35% in the oral nimodipine group—a 19% relative reduction.
• A markedly higher proportion of GTx-104 patients (54%) achieved a relative dose intensity (RDI) of 95% or above, while only 8% of the oral group reached similar consistency, underscoring IV’s dosing reliability.
• Additional benefits included improved functional outcomes at 90 days (via modified Rankin scale), superior quality of life scores (EQ-5D-3L), and reduced ICU stays, readmissions, and ventilator usage.
• Treatment-emergent adverse events were comparable across both arms, and no new safety concerns emerged.

In addition, while mortality was higher in the GTx-104 arm (8 deaths) than in the oral arm (4 deaths), Grace emphasizes that all fatalities were attributed to the underlying severity of aSAH—not the treatment—affirming the safety profile of GTx-104.

Strategic Implications & Next Moves

Given these encouraging outcomes, Grace plans to engage with the FDA and is targeting an NDA submission in the first half of 2025. This marks a hopeful step forward for innovation in aSAH—a condition that has seen little therapeutic progress in nearly four decades.

GTx-104, produced via a novel nanoparticle-based technology, enables aqueous IV delivery of nimodipine, a drug traditionally limited by solubility and administration challenges. The IV route could bypass nasogastric dependency and mitigate complications like food-effect variability and dosing errors.

This formulation could represent a meaningful improvement in the acute management of critically ill aSAH patients, ensuring more consistent drug delivery, better tolerability, and improved overall clinical outcomes.

Why This Matters for BiopharmaWire Readers

• Clinical Relevance: aSAH is a severe, often devastating form of stroke with limited therapeutic innovation—GTx-104’s success could reshape treatment norms.
• Drug Delivery Innovation: The IV nimodipine platform exemplifies how reformulating existing agents can substantially enhance efficacy and safety outcomes.
• Regulatory Watch: With an NDA expected imminently, this marks a key watchpoint for potential approval and adoption.
• Economics & Health Systems: Evidence of reduced ICU burden and improved patient outcomes speaks directly to hospital stakeholders and healthcare payers.

Conclusion

Grace Therapeutics’ positive STRIVE-ON results highlight GTx-104 as a potent new avenue for managing aSAH—offering reduced hypotension risk and improved ICU outcomes. With an NDA submission underway, GTx-104 may soon become the first meaningful innovation in aSAH care in decades.