Reviva Announces Positive Topline Results from Global Pivotal Phase 3 RECOVER Trial of Brilaroxazine in Schizophrenia

- Successfully met primary endpoint; brilaroxazine 50 mg delivered a statistically significant and clinically meaningful 10.1-point reduction in Positive and Negative Syndrome Scale (PANSS) total score vs. placebo at week 4, p<0.001 -

- Statistically significant and clinically meaningful reductions in all major symptom domains and secondary endpoints at week 4 with 50 mg of brilaroxazine vs. placebo -

- Generally well-tolerated with a side effect profile comparable to placebo for the 15 and 50 mg doses of brilaroxazine; discontinuation rates for brilaroxazine lower than placebo -

- Topline data from 1-year open-label extension (OLE) trial expected Q4 2024 -

- Conference call and webcast today at 8:30 a.m. ET -

CUPERTINO, Calif., Oct. 30, 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 positive topline results and successful completion of its pivotal Phase 3 RECOVER trial evaluating the efficacy, safety and tolerability of once-daily brilaroxazine, a serotonin-dopamine signaling modulator in adults with schizophrenia. The trial successfully met its primary endpoint, with brilaroxazine at the 50 mg dose achieving a statistically significant and clinically meaningful 10.1-point reduction in Positive and Negative Syndrome Scale (PANSS) total score compared to placebo (-23.9 brilaroxazine 50 mg vs. -13.8 placebo, p<0.001) at week 4. Brilaroxazine also achieved statistically significant and clinically meaningful reductions in all major symptom domains and secondary endpoints at week 4 with the 50 mg dose vs. placebo. The 15 mg dose of brilaroxazine was numerically superior to placebo on the primary endpoint and most secondary endpoints, and reached statistical significance on two key secondary endpoints.

“We are excited to report positive topline results for our Phase 3 RECOVER trial, further confirming the well-tolerated safety profile and improvements in all major symptom domains including PANSS total score, positive and negative symptoms, and Clinical Global Impression – Severity score (CGI-S) as previously observed in our Phase 2 REFRESH trial,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. “Importantly, we believe the unique multifaceted mechanism of action of brilaroxazine, a serotonin-dopamine signaling modulator, has potential to improve additional key disease drivers like neuroinflammation. The RECOVER pivotal results highlight the potentially differentiated therapeutic profile of once-daily brilaroxazine and underscore the potential to address treatment limitations for the 24 million people living with schizophrenia around the world. We expect to report long-term data from our OLE trial in the fourth quarter of 2024 and initiate a registrational Phase 3 RECOVER-2 trial in the first quarter of 2024, which if successful will help support our planned New Drug Application (NDA) submission to the FDA expected in 2025.”