Positive Topline Results Reported for Phase 3 Clinical Trial Evaluating Schizophrenia Treatment

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Results of a phase 3 clinical trial evaluating a treatment for adults with schizophrenia reported that its primary endpoint has been met, with a 50 mg dose of the treatment showing a statistically significant reduction of 10.1 points in the Positive and Negative Syndrome Scale (PANSS) total score compared with placebo at week 4.

The Phase 3 RECOVER trial evaluated the efficacy, safety, and tolerability of brilaroxazine, a serotonin-dopamine signaling modulator, in the treatment of adults with schizophrenia. The trial’s results showed statistically significant reductions in all major symptom domains and secondary endpoints at week 4 with the 50 mg dose of brilaroxazine, while the 15 mg dose showed numerical superiority to the placebo on the primary endpoint and some secondary endpoints, reaching statistical significance on 2 secondary endpoints.¹

The trial’s clinical safety and tolerability findings indicated that there were no drug-related or treatment-emergent serious adverse events observed for brilaroxazine after 4 weeks of treatment. No incidence of suicidal ideation was reported. There were no significant changes in body weight, blood glucose levels, lipid levels, or endocrine hormones (prolactin, thyroid hormone) compared with placebo.¹

Reports of akathisia and extrapyramidal symptoms were minimal, with less than 1% reported for brilaroxazine 50 mg and none reported for the 15 mg dose. Discontinuation rates with brilaroxazine were lower than those with placebo, with 16% in the brilaroxazine 50 mg group and 19% in the 15 mg group, compared with 22% in the placebo group.¹

“The consistent response across all primary and secondary endpoints at the 50 mg dose and improvement in all major domains, including negative symptoms and personal and social performance, is strong support for brilaroxazine’s robust activity,” said Larry Ereshefsky, PharmD, BCPP, FCCP, chief scientific officer at Follow the Molecule: CNS Consulting and Clinical Sciences by CenExel Research, in a press release.

“Moreover, the low placebo response is indicative of a well-run trial employing quality sites and investigators. This broad efficacy profile, coupled with low discontinuation rates and favorable tolerability supports the potential of brilaroxazine to address limitations of standards of care and potentially be a long-term treatment option for this chronic and complex disease.”

According to Laxminarayan Bhat, PhD, founder, president, and CEO of Reviva Pharmaceutical Holdings Inc, developer of brilaroxazine, brilaroxazine’s mechanism of action has the potential to address additional drivers of schizophrenia. “Importantly, we believe the unique, multifaceted mechanism of action of brilaroxazine, a serotonin-dopamine signaling modulator, has potential to improve additional key disease drivers like neuroinflammation,” Bhat said in a press release.

“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’s brilaroxazine program consists of the positive phase 2 REFRESH and phase 3 RECOVER trials. An ongoing 1-year Open-Label Extension (OLE) trial is evaluating long-term safety and tolerability, and a confirmatory global, randomized 6-week phase 3 RECOVER-2 trial is set to commence in the first quarter of 2024.¹

According to Bhat, the company expects to report topline data from the OLE trial in fourth-quarter 2024 and to initiate the registrational phase 3 RECOVER-2 trial in first-quarter 2024, with completion anticipated in early 2025. These data from the brilaroxazine program may potentially support the planned New Drug Application (NDA) submission to the US Food and Drug Administration (FDA) in 2025.¹

Stay up-to-date on news related to research on promising new treatments for schizophrenia and a wide variety of other psychiatric disorders at psychiatrictimes.com.

Note: Assistance from ChatGPT was used in the preparation of this article.

Reference

1. Reviva announces positive topline results from global pivotal phase 3 RECOVER trial of brilaroxazine in schizophrenia. Reviva Pharmaceuticals. News release. October 30, 2023. Accessed October 30, 2023. https://revivapharma.com/reviva-announces-positive-topline-results-from-global-pivotal-phase-3-recover-trial-of-brilaroxazine-in-schizophrenia/#:~:text=%E2%80%9CWe%20are%20excited%20to%20report,CGI%2DS)%20as%20previously%20observed