Could This Be A Breakthrough in Mental Health? Reviva's Schizophrenia Drug Shows Promising Results In Key Trial
Reviva Pharmaceuticals Holdings Inc. Ordinary Shares
Reviva Pharmaceuticals Holdings Inc (NASDAQ:RVPH) announced the topline results of its pivotal Phase 3 RECOVER trial evaluating brilaroxazine, a serotonin-dopamine signaling modulator in adults with schizophrenia.
The trial 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) at week 4.
PANSS is a medical scale used for measuring the symptom severity of patients with schizophrenia.
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.
The brilaroxazine program consists of the completed Phase 2 REFRESH and Phase 3 RECOVER trials, as well as an ongoing 1-year OLE trial evaluating the long-term safety and tolerability, and soon-to-be-initiated confirmatory 6-week Phase 3 RECOVER-2 trial.
The company expects to report topline data from the OLE trial in Q4 2024 and initiate the registrational Phase 3 RECOVER-2 trial in Q1 2024, with completion anticipated in early 2025.
These data from the brilaroxazine program will potentially support the planned NDA submission to the FDA in 2025.
Price Action: RVPH shares are up 5.33% at $3.95 on the last check Monday.