The trial compared the efficacy and safety of brilaroxazine with that of placebo for acute schizophrenia. Credit: PeopleImages.com – Yuri A / Shutterstock.

US-based pharmaceutical company Reviva Pharmaceuticals has reported positive topline data from its Phase III RECOVER clinical trial of brilaroxazine in adult patients with schizophrenia.

The randomised, placebo-controlled trial compared the efficacy and safety of the serotonin-dopamine signalling modulator brilaroxazine with that of placebo in 412 acute schizophrenia patients.

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A decline in Positive and Negative Syndrome Scale (PANSS) total score from baseline to day 28 against placebo is the trial’s primary endpoint.

According to the findings, the study met its primary endpoint, with 50mg of brilaroxazine attaining a statistically significant and clinically meaningful decline of 10.1 points in PANSS total score versus the placebo at week four. 

In addition, the 50mg dose of brilaroxazine caused a decline in all crucial symptom domains, as well as secondary endpoints. 

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No drug-linked or treatment-emergent serious adverse events were reported following treatment with brilaroxazine. 

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Reviva Pharmaceuticals founder, president and CEO Laxminarayan Bhat said: “We are excited to report positive topline results for our Phase III RECOVER trial, further confirming the well-tolerated safety profile and improvements in all major symptom domains, including PANSS total score, positive and negative symptoms and Clinical Global Impression – Severity score (CGI-S) as previously observed in our Phase II REFRESH trial.

“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.”

Reviva Pharmaceuticals expects to report long-term data from the trial next year before initiating RECOVER-2, a registrational Phase III trial of brilaroxazine.

If successful, the RECOVER-2 trial will support the company’s planned New Drug Application submission to the US Food and Drug Administration (FDA) in 2025.

Based in California, Reviva aims to develop and commercialise next-generation therapeutics for diseases representing unmet medical needs.

The company’s pipeline also includes the drug candidate RP1208 for depression and obesity.