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Ovid Therapeutics and Graviton Bioscience Announce Topline Data from a Phase 1 Clinical Trial Studying OV888/GV101 Capsule, a Potential First-In-Class Therapy for Cerebral Cavernous Malformations
The Phase 1 study for OV888/GV101 capsule met its objective, demonstrating a favorable safety and tolerability profile with no serious adverse eventsSecondary
About this update from Ovid Therapeutics Inc.
[{"type":"text","content":"The Phase 1 study for OV888/GV101 capsule met its objective, demonstrating a favorable safety and tolerability profile with no serious adverse eventsSecondary endpoint results indicate that the target pharmacokinetic profile was achieved at the targeted clinical dose, supporting once daily dosingOV888/GV101 capsule was shown to be biologically active in participants and elicited dose-dependent pharmacodynamic effects within the planned therapeutic dose rangeA Phase 2 study for the treatment of cerebral cavernous malformations is expected to initiate in the second half of 2024 NEW YORK, July 01, 2024 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (NASDAQ: OVID), a biopharmaceutical company dedicated to improving the lives of people affected by rare epilepsies and brain conditions, and Graviton Bioscience Corporation, a privately held clinical-stage biotechnology company focused on developing Rho-associated coiled-coil containing protein kinase 2 (ROCK2) inhibitors and other innovative therapeutic compounds, today announced the results from their Phase 1 healthy volunteer study evaluating the safety, tolerability, and pharmacokinetic (PK) profile of multiple ascending doses of OV888/GV101 capsule. Ovid and Graviton plan to progress to a Phase 2 clinical study in cerebral cavernous malformations (CCM) later this year. “The safety data support progression to a proof-of-concept study in people with CCM, a community that has no FDA-approved pharmacologic treatment available today. The standard of care for people diagnosed with CCM is often ‘watchful waiting’ or high-risk brain surgery for eligible symptomatic patients. We hope to bring an oral, potentially first-in-class, highly selective ROCK2 inhibitor to this community,” said Dr. Jeremy Levin, D.Phil, MB BChir., Chairman and CEO of Ovid Therapeutics. “Our collaboration with Graviton Bioscience is both successful and exciting. We are unpacking the therapeutic potential of inhibiting ROCK2. This mechanism of action has broad potential applications in multiple additional neurovascular and neuro-inflammatory conditions, which we look forward to pursuing together in the future.” “Today’s data reinforce our conviction that OV888/GV101 capsule has the potential to become the first oral treatment for CCM,” said Samuel Waksal, Ph.D., CEO and founder of Graviton. “Based on nonclinical data, we b...