Reviva Pharmaceuticals Holdings, Inc. (RVPH) announced on Monday preliminary top-line results for the open-label extension (OLE) of its Phase 3 RECOVER study. This study is designed to assess the long-term safety and tolerability of brilaroxazine in patients with schizophrenia.
In this trial, a total of 435 patients were enrolled in the OLE, divided across three dosage groups receiving 15 mg, 30 mg, and 50 mg doses of brilaroxazine.
The biopharmaceutical company reported that a once-daily administration of brilaroxazine showed favorable long-term safety alongside robust broad-spectrum efficacy sustained over a one-year period.
All tested doses of brilaroxazine proved effective and were generally well-tolerated, exhibiting low rates of adverse events and treatment discontinuations.
Laxminarayan Bhat, President and CEO of Reviva, expressed anticipation for presenting the comprehensive data from the RECOVER study's OLE segment. This data—expected in the first quarter of 2025—will encompass long-term safety, tolerability, and efficacy particulars, in addition to vocal and blood biomarker data offering independent measures of efficacy.
As of now, Reviva's stock is trading at $2.57 on the Nasdaq, reflecting a 1.52 percent decline.
