Reviva Pharmaceuticals has announced positive preliminary topline data from the open-label extension (OLE) of its Phase 3 RECOVER study, evaluating the long-term safety and tolerability of brilaroxazine in patients with schizophrenia. The study demonstrated sustained efficacy and a favorable safety profile over one year of treatment.
Long-Term Efficacy and Safety
The OLE enrolled 435 patients across three dose groups (15 mg, 30 mg, and 50 mg) of once-daily brilaroxazine. Preliminary efficacy results from 113 patients who completed a year of treatment showed dose-dependent improvements in schizophrenia symptoms. Specifically, PANSS (Positive and Negative Syndrome Scale) total scores decreased by 15.2 points, 18.6 points, and 20.8 points in the 15 mg, 30 mg, and 50 mg groups, respectively, from baseline to the final observation at one year.
Pooled data analysis revealed a significant decrease of 18.6 points in PANSS total scores (p<0.0001), a 5.2-point decrease in PANSS positive symptoms (p<0.0001), and a 4.5-point decrease in PANSS negative symptoms (p<0.0001). In patients who rolled over from the double-blind portion of the RECOVER trial, 87% achieved a 30-point or greater decrease in PANSS total score, 65% achieved a 40-point or greater decrease, and 34% achieved a 50-point or greater decrease.
Tolerability and Adherence
Brilaroxazine was generally well-tolerated, with only 15.2% of participants reporting at least one treatment-related adverse event (TRAE). These events were mostly mild (12.2%) or moderate (3%) in severity and transient. The most common TRAEs were weight increase (3.2%), insomnia (1.8%), and somnolence (1.6%). Notably, no drug-related serious adverse events (SAEs) were reported. Discontinuation rates were favorable at 35% after one year, which is lower than many other approved antipsychotics, where discontinuation rates can range from the mid-40% to 70%.
RECOVER-2 and Future Plans
Reviva is planning to initiate its confirmatory Phase 3 RECOVER-2 trial in Q1 2025. This trial will have a similar design to the RECOVER trial but will use a 30 mg dose in place of the 15 mg dose arm. The company expects to enroll 450 patients, randomized 1:1:1 to 30 mg, 50 mg, and placebo arms. The primary endpoints will be measured over a 4-week period.
Reviva anticipates reporting the full data set from the OLE portion of the RECOVER study, including long-term safety, tolerability, and efficacy data, as well as vocal and blood biomarker data, in the first quarter of 2025. This data, along with the RECOVER-2 data, will form part of the New Drug Application (NDA) package for brilaroxazine that Reviva will submit to the FDA.
