Reviva Announces Enrollment Update for Open Label Extension Study Evaluating Brilaroxazine in Schizophrenia

– 358 enrolled and 223 patients currently on treatment across sites in the USA, Europe and Asia –

– Brilaroxazine is generally well tolerated to date in patients with acute and stable schizophrenia –

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

CUPERTINO, Calif., May 15, 2024 (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 an enrollment update to the ongoing 1-year open-label extension (OLE) study evaluating the long-term safety and tolerability of brilaroxazine in patients with schizophrenia.

“We are very pleased with the pace of enrollment of our OLE study, which is progressing well across sites in the USA, Europe and Asia. As of mid-May we have 358 patients enrolled in the study, 223 patients that are currently on treatment, over 90 patients have completed 6-9 months, and 23 patients who have completed one year of treatment,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. “Importantly, we are close to gathering long-term safety data in 100 patients with one year of treatment, which is a requirement for our planned New Drug Application (NDA) submission to the Food and Drug Administration (FDA) expected in Q4 2025. To date, brilaroxazine has been generally well tolerated across patients with acute and stable schizophrenia in the OLE study. We look forward to reporting topline 12 months long-term safety data in the fourth quarter of this year.”

RECOVER Trial OLE Enrollment Status Update As of May 15, 2024

• Trial progressing as expected in the USA, Europe (Bulgaria) and Asia (India)
• 358 patients enrolled in the study
• 223 patients currently on treatment in the study
• Over 130 patients currently in the study have completed 1-6 months of treatment
• Over 90 patients currently in the study have completed 6-9 months of treatment
• 23 patients have completed 12 months of treatment
• Long-term safety data from 100 patients who have completed 12 months of treatment is a requirement for brilaroxazine’s NDA submission to the FDA
• Reviva is on track to complete the 12 months long-term safety study in Q4 2024

The RECOVER Trial OLE is a randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of brilaroxazine at fixed doses of 15 mg or 50 mg, administered once daily for 28 days in subjects with an acute exacerbation of schizophrenia, followed by the long-term safety assessment of brilaroxazine at flexible doses of either 15, 30 or 50 mg administered once daily for 52 weeks in subjects with stable schizophrenia. The OLE study will include both double-blind rollover and de novo subjects with stable schizophrenia.