Reviva Pharmaceuticals Holdings, Inc. Reports Successful Phase 3 RECOVER Trial for Brilaroxazine

Reviva Pharmaceuticals Holdings, Inc. reported the successful completion of its key Phase 3 RECOVER trial for brilaroxazine, which represents a significant advancement for the treatment of schizophrenia. The outcomes have been promising in the trial, which assessed the safety, tolerability, and effectiveness of once-daily brilaroxazine, a serotonin-dopamine signaling modulator, in individuals with schizophrenia.

Key Findings

• The pivotal trial achieved its primary aim, showing that the 50 mg dose of brilaroxazine reduced the Positive and Negative Syndrome Scale (PANSS) total score by 10.1 points when compared to a placebo, a statistically significant and clinically meaningful difference.
• This result represents a major breakthrough in the management of schizophrenia, a condition that affects over 24 million people globally.

Additional Outcomes

In addition to the primary endpoint, brilaroxazine achieved statistically significant and clinically meaningful reductions in all major symptom domains and secondary endpoints at week 4 compared to the placebo. This includes:

• Positive and negative symptoms
• Personal and social performance
• PANSS Social Cognition

The broad efficacy profile, coupled with low discontinuation rates and favorable tolerability, suggests that brilaroxazine could address the limitations of current standards of care and offer a long-term treatment option for schizophrenia.

Safety and Tolerability

The clinical safety and tolerability findings of brilaroxazine further support its potential as a treatment option. Key points include:

• No drug-related serious adverse events were observed.
• No incidence of suicidal ideation.
• No significant changes in body weight, blood glucose levels, lipid levels, or endocrine hormones when compared to the placebo.
• Akathisia and extrapyramidal symptoms were reported in less than 1% of patients taking brilaroxazine.

Future Plans

Reviva Pharmaceuticals plans to initiate a registrational Phase 3 RECOVER-2 trial in the first quarter of 2024, with the aim of supporting a New Drug Application (NDA) submission to the FDA in 2025. This advancement could significantly improve treatment options for individuals living with schizophrenia, providing hope for better management and enhanced quality of life.

Statements from Leadership

Laxminarayan Bhat, the Founder, President, and CEO of Reviva, expressed excitement about the results and emphasized the multifaceted mechanism of action of brilaroxazine, which could potentially address key disease drivers like neuroinflammation. The long-term data from the ongoing OLE trial is expected to be reported in the fourth quarter of 2024, further adding to the growing body of evidence supporting brilaroxazine as a promising treatment for schizophrenia.

Reference

B2i. (2023, October 30). Reviva announces Positive topline results from global pivotal phase 3 RECOVER trial of brilaroxazine in schizophrenia. Reviva Pharmaceuticals.