Business
Reviva Announces Enrollment Completion for Pivotal Phase 3 RECOVER Study for Brilaroxazine in Schizophrenia
- 402 patients completed enrollment across multiple sites in the US, Europe, and Asia – - Topline data for Phase 3 RECOVER study expected in October 2023 - -
About this update from Reviva Pharmaceuticals Holdings, Inc.
[{"type":"text","content":"- 402 patients completed enrollment across multiple sites in the US, Europe, and Asia – - Topline data for Phase 3 RECOVER study expected in October 2023 - - Completion of 1-year open-label extension clinical study expected in Q3 2024 - CUPERTINO, Calif., Aug. 17, 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 enrollment is complete in the pivotal Phase 3 RECOVER study evaluating brilaroxazine for schizophrenia, with 402 patients enrolled at multiple sites in the United States (~60%), Europe (~10%), and Asia (~30%). “Completing enrollment of all 402 patients across 40 global sites in the pivotal Phase 3 RECOVER trial is a key milestone for our late-stage program in schizophrenia,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. “We believe RECOVER will further reinforce the ability of brilaroxazine to improve multiple symptom domains of schizophrenia including positive and negative symptoms and neuroinflammation and demonstrate a well-tolerated safety profile with no cardiac or metabolic side effects as seen in our Phase 2 trial. We are also pleased to announce that we have over 50% of patients enrolled in our 1-year open-label extension study for brilaroxazine in schizophrenia. We look forward to reporting topline efficacy and safety data from RECOVER expected in October 2023.” RECOVER is a global Phase 3, randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of brilaroxazine in 402 patients with acute schizophrenia compared to placebo. Brilaroxazine will be 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 Symptoms Assessment 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. A 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 sc...