Reviva Pharmaceuticals announces full dataset for one-year Phase 3 RECOVER study

Reviva Pharmaceuticals (RVPH) announced a full dataset and successful completion of the Company’s Phase 3 RECOVER open-label extension 1-year study evaluating the long-term safety, tolerability and efficacy of brilaroxazine in patients with schizophrenia. Once daily brilaroxazine led to robust broad-spectrum efficacy that was sustained over 1-year and was generally well tolerated with a discontinuation rate of 35% in this long-term study. Brilaroxazine is a novel serotonin dopamine signaling modulator with multi-faceted direct and indirect activities on critical pathways implicated in schizophrenia. Key safety, efficacy and compliance findings for pooled analysis of brilaroxazine at 15 mg, 30 mg, and 50 mg include: Dose-dependent, broad spectrum, clinically meaningful and sustained long-term efficacy across all major symptom domains of schizophrenia. Clinical safety, tolerability and adherence findings with pooled doses of brilaroxazine in the OLE trial patients support a well-tolerated safety profile: 8.5% of participants reported at least one treatment-emergent adverse event, which were mostly mild or moderate in severity and transient in nature Most common TEAEs 2% were headache, insomnia, sleep disturbance and mild tremor. Brilaroxazine was not associated with any clinically meaningful changes in movement disorder scales used for evaluating motor side effects such as akathisia and extrapyramidal symptoms over 1-year treatment Mild weight gain reported in the pooled brilaroxazine dose group over 1-year treatment. Weight gain was not dose dependent with least weight gain at 50 mg dose No drug related serious adverse events observed or major safety concerns reported for brilaroxazine after 1-year of treatment; 5 serious adverse events were reported, and none were related to brilaroxazine treatment No incidence of clinically significant cardiac side effects, or gastrointestinal side effects No incidence of drug induced liver injury No significant change in blood glucose levels Improved lipids levels and endocrine hormone levels Treatment discontinuation rate of 35% reported in this one-year study primarily due to withdrawal of consent, participant lost to follow up and treatment related adverse events. We believe that collectively, the Phase 3 RECOVER OLE study findings further strengthen the safety, efficacy and treatment adherence findings in the Phase 3 RECOVER double-blind study. The RECOVER OLE Study is a global, open-label, multicenter study to assess the safety, tolerability and efficacy of brilaroxazine at flexible doses of 15, 30 or 50 mg, administered once daily for 52-week in patients with stable schizophrenia. The OLE study included both rollover participants from the RECOVER double-blind study and de novo participants with stable schizophrenia. Long-term safety data from 100 patients who have completed 1-year of treatment is a requirement for brilaroxazine’s NDA submission to the U.S. Food and Drug Administration.