Treatment with brilaroxazine was associated with clinically meaningful reductions in all major symptom domains in adults with schizophrenia, according to positive topline data from a pivotal phase 3 trial.
The randomized, double-blind, placebo-controlled, multicenter RECOVER trial (ClinicalTrials.gov Identifier: NCT05184335) evaluated the efficacy and safety of brilaroxazine, a novel serotonin-dopamine signaling modulator, in 412 patients with acute schizophrenia. Study participants were randomly assigned to receive either brilaroxazine at fixed doses of 15mg or 50mg once daily or placebo for 28 days.
Findings showed a statistically significant and clinically meaningful 10.1-point reduction in Positive and Negative Syndrome Scale (PANSS; primary endpoint) total score with brilaroxazine 50mg vs placebo (-23.9 vs -13.8 points, respectively; P <.001) at week 4.
Statistically significant improvements in key secondary endpoints including positive symptoms (P <.001), negative symptoms (P <.001), NS Marder Factor (P =.003), PANSS social cognition (P <.001), PANSS excitement/agitation (P <.001), personal and social performance (P <.001), and Clinical Global Impressions-Scale score (P <.001) were also observed with the 50mg dose.
As for safety, there were no drug-related or treatment-emergent serious adverse events observed with brilaroxazine. Compared with placebo, no significant changes to body weight, blood glucose levels, lipid levels, or endocrine hormones were reported.
“The RECOVER pivotal results highlight the potentially differentiated therapeutic profile of once-daily brilaroxazine and underscore the potential to address treatment limitations for the 24 million people living with schizophrenia around the world,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. “We expect to report long-term data from our [open-label extension] trial in the fourth quarter of 2024 and initiate a registrational phase 3 RECOVER-2 trial in the first quarter of 2024, which if successful will help support our planned New Drug Application (NDA) submission to the FDA expected in 2025.”
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