Reviva’s Schizophrenia Drug Demonstrates Reduction in all Major Symptoms
Reviva Pharmaceuticals (Nasdaq: RVPH) has announced positive topline results and successful completion of its pivotal Phase 3 RECOVER trial evaluating the efficacy, safety and tolerability of once-daily brilaroxazine, a serotonin-dopamine signaling modulator in adults with schizophrenia. The company’s share price rose 50% following the news.
The company expects to report long-term data from its open label extension trial in Q4 2024 and to submit a New Drug Application (NDA) submission to the FDA in 2025.
Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva, said, “We believe the unique multifaceted mechanism of action of brilaroxazine, a serotonin-dopamine signaling modulator, has potential to improve additional key disease drivers like neuroinflammation. The RECOVER pivotal results highlight the potentially differentiated therapeutic profile of once-daily brilaroxazine and underscore the potential to address treatment limitations for the 24 million people living with schizophrenia around the world.”
Highlights
RECOVER is a global Phase 3, randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of brilaroxazine in 412 patients with acute schizophrenia compared to placebo.
Brilaroxazine demonstrated no drug-related serious adverse events, no incidence of suicidal ideation, no significant change in bodyweight, blood glucose levels, lipids levels, or endocrine hormones (prolactin, thyroid hormone) compared to placebo.
Larry Ereshefsky, PharmD, BCPP, FCCP, Chief Scientific Officer, said, “The consistent response across all primary and secondary endpoints at the 50 mg dose and improvement in all major domains, including, negative symptoms and personal and social performance is strong support for brilaroxazine’s robust activity. Moreover, the low placebo response is indicative of a well-run trial employing quality sites and investigators. This broad efficacy profile coupled with low discontinuation rates and favorable tolerability supports the potential of brilaroxazine to address limitations of standards of care and potentially be a long-term treatment option for this chronic and complex disease.”
About Reviva
Reviva is a late-stage pharmaceutical company that discovers, develops, and seeks to commercialize next-generation therapeutics for diseases representing unmet medical needs and burdens to society, patients, and their families. Reviva’s current pipeline focuses on the central nervous system, inflammatory and cardiometabolic diseases. Reviva’s pipeline currently includes two drug candidates, RP5063 (brilaroxazine) and RP1208. Both are new chemical entities discovered in-house. Reviva has been granted composition of matter patents for both RP5063 and RP1208 in the United States, Europe, and several other countries.