In the wake of the approval Bristol Myers Squibb’s Cobenfy, it seems that news has ramped up in the schizophrenia space. The latest contender is Reviva Pharmaceuticals’ brilaroxazine, which reduced schizophrenia symptoms over a year in a phase 3 trial.
Reviva was testing brilaroxazine, an antipsychotic and dopamine-serotonin system modulator, in the open-label extension portion of the ongoing RECOVER study. The study enrolled 435 patients who received either a 15-mg, 30-mg or 50-mg daily dose of brilaroxazine, with preliminary efficacy results taken from 113 of these patients who have completed a year’s treatment.
These dose groups saw reductions in a score of positive and negative symptoms of schizophrenia of 15.2, 18.6 and 20.8 points, respectively, from baseline over that period.
There were no serious adverse events deemed related to the drug. However, the discontinuation rate reached 35%, which Reviva attributed “primarily to withdrawal of consent (22%), participant lost to follow up (7%), and treatment-related adverse events (1.6%).”
A total of 15.2% of participants reported at least one treatment-related adverse event, which were mostly mild or moderate in severity and transient in nature, Reviva said. The most common were weight increase (3.2%), insomnia (1.8%) and somnolence (1.6%).
“We believe these topline preliminary long-term data build on the strong clinical evidence demonstrating that brilaroxazine can improve all major symptom domains of schizophrenia, and now importantly, show sustained efficacy over time,” Reviva CEO Laxminarayan Bhat, Ph.D., said in the release.
“Moreover, the generally well-tolerated safety profile and high compliance rate following one year of treatment highlight the potential once daily brilaroxazine holds to address major barriers to successful long-term treatment in schizophrenia,” Bhat added. “We look forward to reporting the full data set from the OLE portion of the RECOVER study, which will include long-term safety, tolerability and efficacy data, as well as vocal and blood biomarker data as additional independent measures of efficacy, expected in the first quarter of 2025.”
Since BMS saw Cobenfy, formally known as KarXT, secure the first new FDA approval for schizophrenia in decades, barely a week has gone by without some fresh developments in the space. Recent months have seen AbbVie's own prospect flunk a pair of phase 2 trials, while Eisai has picked up the Japanese rights to Newron Pharmaceuticals’ add-on schizophrenia treatment and Neurocrine Biosciences’ attempts to keep its own contender in the running have flamed out.