New Phase 3 Clinical Vocal Biomarker Data on Brilaroxazine to Treat Negative Symptoms in Schizophrenia

Reviva Pharmaceuticals today announced the publication of clinical vocal and speech biomarker data from the RECOVER phase 3 clinical trial and the therapeutic potential of brilaroxazine for the treatment of schizophrenia. The article, “A Single, Interpretable Vocal Biomarker for Enriching Antipsychotic Clinical Trials,” was published in the peer-reviewed journal Biological Psychiatry.¹

Brilaroxazine is a new chemical entity with potent affinity and selectivity against key serotonin and dopamine receptors implicated in the pathophysiology of several conditions including schizophrenia, psoriasis and interstitial lung diseases like pulmonary hypertension, pulmonary arterial hypertension and idiopathic pulmonary fibrosis.

The published findings reinforce the treatment effect of brilaroxazine on negative symptoms and other symptom domains in schizophrenia and support clinician-assessed efficacy outcomes, as well as support the use of speech latency as an enrichment tool that can reduce sample-size and enhance outcomes in clinical trials for schizophrenia.

“Publication of our vocal biomarker findings from our RECOVER phase 3 trial in this top-tier, peer-reviewed journal underscores the robustness of our clinical data and the differentiated therapeutic potential of brilaroxazine to address unmet needs in schizophrenia and its major symptom domain negative symptoms,” said Laxminarayan Bhat, PhD, who is the founder, president, and CEO of Reviva. “These results show speech latency as a scalable, objective biomarker that can be used to evaluate brilaroxazine’s effect on negative symptoms and other core domains of schizophrenia, as well as corroborative of clinician-assessed efficacy from our trial.”

The trial successfully met all primary and secondary endpoints with statistically significant and clinically meaningful reductions across all major symptom domains including reduction in key proinflammatory cytokines implicated in the pathophysiology of schizophrenia and comorbid inflammatory conditions at week 4 with 50 mg of brilaroxazine compared with placebo, with a generally well-tolerated adverse effect profile comparable to placebo and discontinuation rates lower than placebo.²

Data highlights include:

• Speech latencies classified the presence of moderate to severe negative symptoms (VBM-positive) and low negative symptoms (VBM-negative) in patients randomly assigned to the RECOVER trial.
• A greater percentage of patients who were VBM positive showed significant treatment response, as measured by clinician assessed efficacy outcomes of brilaroxazine for negative symptoms and other key symptom domains of schizophrenia.
• Patients who were VBM positive showed a fast and strong response to brilaroxazine treatment in nearly every outcome measure, especially negative symptoms.
• Investigators also determined that speech latency 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. It could reduce sample-size needs and enhance the trial outcomes as an enrichment tool, thereby potentially reducing clinical trial costs and burden.

“Beyond this program, we believe this approach could transform limitations of current schizophrenia clinical trials by improving patient stratification, enriching for primary negative symptom populations, and mitigating placebo responses, all of which are factors critical to trial success rates,” concluded Bhat.

References

1. Reviva announces publication on clinical vocal biomarker data from the RECOVER phase 3 clinical trial of brilaroxazine to treat negative symptoms in schizophrenia. News release. January 8, 2026. Accessed January 8, 2026. https://www.globenewswire.com/news-release/2026/01/08/3215319/0/en/Reviva-Announces-Publication-on-Clinical-Vocal-Biomarker-Data-from-the-RECOVER-Phase-3-Clinical-Trial-of-Brilaroxazine-to-Treat-Negative-Symptoms-in-Schizophrenia.html

2. Bhat L, Duerr HA. Open label phase 3 study of brilaroxazine for schizophrenia shows efficacy, tolerability. Psychiatric Times. June 2, 2025. https://www.psychiatrictimes.com/view/open-label-phase-3-study-of-brilaroxazine-for-schizophrenia-shows-efficacy-tolerability