Reviva Pharmaceuticals Holdings Inc (NASDAQ: RVPH) recently released the topline results of its Phase 3 RECOVER trial, showcasing promising outcomes for their schizophrenia drug, brilaroxazine, a serotonin-dopamine signaling modulator. The trial demonstrated a significant reduction in symptom severity and exhibited potential breakthrough potential in the field of mental health.
Delivering on the Promise
In the Phase 3 RECOVER trial, brilaroxazine at a 50 mg dose delivered outstanding results, meeting its primary endpoint. Patients treated with brilaroxazine experienced a statistically significant and clinically meaningful 10.1-point reduction in the Positive and Negative Syndrome Scale (PANSS) total score compared to the placebo group (-23.9 for brilaroxazine 50 mg vs. -13.8 for placebo) after just four weeks of treatment. PANSS is a widely accepted medical scale used to measure symptom severity in patients with schizophrenia.
Furthermore, brilaroxazine demonstrated its effectiveness in all major symptom domains and secondary endpoints, showcasing statistically significant and clinically meaningful improvements at the 50 mg dose compared to the placebo group.
Multiple Dosage Options
Notably, the 15 mg dose of brilaroxazine also showed promising results, being numerically superior to the placebo group on the primary endpoint and most secondary endpoints. It achieved statistical significance on two key secondary endpoints, further affirming the effectiveness of the drug.
The brilaroxazine program includes the completed Phase 2 REFRESH and Phase 3 RECOVER trials. Additionally, an ongoing 1-year OLE trial is evaluating the long-term safety and tolerability of the drug. In the near future, Reviva Pharmaceuticals plans to initiate the confirmatory 6-week Phase 3 RECOVER-2 trial.
The company anticipates reporting topline data from the OLE trial in the fourth quarter of 2024 and initiating the registrational Phase 3 RECOVER-2 trial in the first quarter of 2024. Completion of the Phase 3 RECOVER-2 trial is expected in early 2025. These data from the brilaroxazine program will potentially support the planned submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in 2025.
Following the positive trial results, Reviva Pharmaceuticals Holdings Inc (RVPH) experienced a 5.33% surge in its share price, reaching $3.95.