Reviva Pharmaceuticals Publishes Study on Brilaroxazine in Biological Psychiatry
Reviva Pharmaceuticals Holdings announced the publication, in the peer-reviewed journal Biological Psychiatry, of an article entitled A Single, Interpretable Vocal Biomarker for Enriching Antipsychotic Clinical Trials that highlights clinical vocal biomarker data from the RECOVER Phase 3 clinical trial and the therapeutic potential of brilaroxazine for the treatment of schizophrenia. The publication is available at revivapharma.com/publications. Highlights of brilaroxazine vocal or speech biomarker data from the pivotal Phase 3 RECOVER trial in schizophrenia include: Speech latencies classified the presence of moderate to severe negative symptoms and low negative symptoms in patients randomized to the RECOVER trial. A greater percentage of VBM positive patients showed significant treatment response, as measured by clinician assessed efficacy outcomes of brilaroxazine for negative symptoms and other key symptom domains of schizophrenia. VBM-positive patients showed a fast and strong response to brilaroxazine treatment in nearly every outcome measure, especially negative symptoms. Speech latency, an objective measure of verbal response time, is sensitive to cognitive, social, and motivational factors, and can be assayed from psychiatric interviews. Speech latency differentiates patients with moderate-to-severe vs. low negative symptoms across countries and languages. As an enrichment tool, it could reduce sample-size needs and enhance the trial outcomes thereby reducing clinical trial costs and burden.
