- Reviva Pharmaceuticals ( NASDAQ: RVPH ) announced Monday that the U.S. enrollment in its pivotal global Phase 3 trial for lead candidate brilaroxazine in schizophrenia had exceeded 30%, and patient recruitments in Asia are expected next month.
- The RECOVER trial is designed to evaluate brilaroxazine against placebo in about 400 patients with acute schizophrenia.
- The company said that the regulators in India greenlighted the trial, and enrollments at several study sites in the country are expected in 2022.
- “Our pivotal, global Phase 3 trial for our lead clinical candidate brilaroxazine continues to progress well, with over 30% enrolled in the United States, multiple sites recently initiated in Europe, and planned initiation of multiple sites in India before year-end,” CEO Laxminarayan Bhat said.
- Topline data from the RECOVER study are expected in mid-2023.
- Reviva ( RVPH ) shares surged in January after the company announced that the FDA cleared the late-stage trial.
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Reviva issues enrollment update on pivotal trial for lead candidate