Reviva Pharmaceuticals (NASDAQ:RVPH) completed enrollment in the pivotal Phase 3 RECOVER study, evaluating brilaroxazine for schizophrenia, with 402 patients enrolled across 40 sites in the U.S., Europe, and Asia.
“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,” Laxminarayan Bhat, Ph.D., founder, president and CEO of Reviva, said in a statement.
In addition, Dr. Bhat said the company has more than 50% of patients enrolled in a one-year open-label extension study for brilaroxazine in schizophrenia. Topline safety and efficacy data are due for release In October 2023.
The primary endpoint is a decrease in positive and negative symptoms assessment total score, compared with placebo from baseline to day 28. Key secondary endpoints include clinical global impression rating scale, positive and negative symptoms, social functioning and cognition.
