Reviva Announces Last Patient Evaluated in Pivotal Phase 3 RECOVER Trial for Brilaroxazine in Schizophrenia
CUPERTINO, Calif., Sept. 25, 2023 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today announced that the last patient in its global pivotal Phase 3 RECOVER study evaluating brilaroxazine for schizophrenia has now completed the study. Topline data from RECOVER are expected in October 2023. Brilaroxazine is a serotonin-dopamine stabilizer with multifaceted activity designed to improve schizophrenia symptoms and accompanying neuroinflammation.
“For the 24 million people worldwide living with schizophrenia, current treatment options do not address all symptoms and often cause side effects and drug-drug interactions which can lead to low adherence and potential relapses,” said Laxminarayan Bhat, Ph.D., Founder, President and CEO of Reviva. “Brilaroxazine is designed to overcome critical gaps in current therapies by offering a well-tolerated safety profile favorable for long-term use, and by addressing the positive, negative, mood, and cognitive symptoms and neuroinflammation associated with schizophrenia. We are pleased to announce the last patient has been evaluated in our global Phase 3 RECOVER trial. We look forward to reporting pivotal topline data this October.”
RECOVER is a global Phase 3, randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of brilaroxazine in 410 patients with acute schizophrenia compared to placebo. Brilaroxazine was administered at fixed doses of 15 mg or 50 mg once daily for 28 days. The primary endpoint is a decrease in Positive and Negative Syndrome Scale (PANSS) total score compared to placebo from baseline to Day 28. Key secondary endpoints include clinical global impression (CGI) rating scale, positive and negative symptoms, social functioning and cognition. An ongoing 1-year open-label extension (OLE) study with flexible doses of 15 mg, 30 mg, or 50 mg will further evaluate the long-term safety and tolerability of brilaroxazine in patients with stable schizophrenia.
Additionally, brilaroxazine has shown promising efficacy for inflammatory diseases psoriasis, pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF) with mitigation of fibrosis and inflammation in translational animal models. Brilaroxazine has already received Orphan Drug Designation by the U.S. FDA for the treatment of PAH and IPF conditions.
To learn more about the clinical and preclinical data available for brilaroxazine, please visit revivapharma.com/publications.
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