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Reviva Pharmaceuticals Provides Update on Clinical Development Pipeline
Enrollment remains on pace for Reviva’s Phase 3 clinical trial for the treatment of schizophrenia at 15 sites across the US with enrollment set to begin at
About this update from Reviva Pharmaceuticals Holdings, Inc.
[{"type":"text","content":"Enrollment remains on pace for Reviva’s Phase 3 clinical trial for the treatment of schizophrenia at 15 sites across the US with enrollment set to begin at sites in Europe and India in Q3 2022 More than 20% of the approximately 400 patients planned for Phase 3 trial already enrolled Reviva anticipates initiating two Phase 2a trials targeting ADHD and Pulmonary Arterial Hypertension in Q4 2022 CUPERTINO, Calif., July 27, 2022 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH), a clinical-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), cardiovascular, metabolic, and inflammatory diseases, is pleased to provide an update on key milestones related to its clinical development pipeline. Phase 3 RECOVER Study Reviva’s pivotal Phase 3 study and a long-term safety trial to assess Reviva’s new chemical entity brilaroxazine for the treatment of subjects with an acute exacerbation of schizophrenia is actively enrolling patients across all sites in the US and remains on schedule to begin enrollment at trial sites in Europe and India during the third quarter of 2022. The global Phase 3 trial, known as RECOVER, is a randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of brilaroxazine over 4 weeks in approximately 400 patients with acute schizophrenia compared to placebo and a 52-week open-label study will further evaluate the long-term safety and tolerability of brilaroxazine in patients with stable schizophrenia. Brilaroxazine will be administered at fixed doses of 15 mg or 50 mg once daily for 4 weeks in the double-blind part of the study and 15 mg to 50 mg flexible dose once daily for 52 weeks in the open-label part of the study. Since Reviva initiated its first clinical site in Bentonville, Arkansas, led by principal investigator Dr. Fayz A. Hudefi, M.D., at the end of January, the team has initiated 15 geographically diverse sites across the US. “We have already enrolled more than 20 percent of the patients for this pivotal study,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. “Based on the positive data reported from our Phase 2 study, we believe brilaroxazine has the potential to address major unmet medical needs and pharmacoeconomics challenges asso...