Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) announced today that topline data from the long-term open-label extension (OLE) portion of its Phase 3 RECOVER study evaluating brilaroxazine in schizophrenia will be presented at the 2025 Congress of the Schizophrenia International Research Society (SIRS). The congress is taking place from March 29 to April 2, 2025, in Chicago, Illinois.
Dr. Laxminarayan Bhat, Founder and CEO of Reviva Pharmaceuticals, will deliver the oral presentation titled "Brilaroxazine Phase 3 Recover 52-Week Open-Label Evaluation of Efficacy and Safety over 12 Months in Stable Schizophrenia Participants" on Sunday, March 30th, from 10:30 AM to 12:00 PM CST as part of the Pharmaceutical Pipeline session.
Long-Term Efficacy and Safety Data
The presentation will feature topline results from the 52-week open-label extension portion of the Phase 3 RECOVER study, which evaluated the long-term efficacy and safety profile of brilaroxazine in patients with stable schizophrenia. This data represents a significant milestone in the clinical development program for brilaroxazine, providing insights into the drug's performance over an extended treatment period.
Schizophrenia affects approximately 24 million people worldwide, according to the World Health Organization, and is characterized by distortions in thinking, perception, emotions, language, sense of self, and behavior. Current treatments often come with significant side effects that can impact patient adherence and quality of life, highlighting the need for novel therapeutic options with improved efficacy and tolerability profiles.
Novel Mechanism of Action
Brilaroxazine (RP5063) is a new chemical entity discovered in-house by Reviva Pharmaceuticals. The compound is being developed to address unmet medical needs in schizophrenia treatment, potentially offering advantages over existing therapies. While specific details about the mechanism of action were not disclosed in the announcement, brilaroxazine represents part of Reviva's focus on developing next-generation therapeutics for central nervous system (CNS) disorders.
"The presentation of this long-term data at SIRS represents an important step in our clinical development program for brilaroxazine," said Dr. Bhat. "We look forward to sharing these results with the scientific community and discussing their implications for patients living with schizophrenia."
Reviva's Pipeline and Focus
Reviva Pharmaceuticals is a late-stage biopharmaceutical company focused on developing therapies for diseases representing unmet medical needs in the areas of central nervous system, inflammatory, and cardiometabolic diseases. The company's pipeline currently includes two drug candidates: brilaroxazine (RP5063) and RP1208, both new chemical entities discovered in-house.
The company has secured composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries, strengthening its intellectual property position as it advances these candidates through clinical development.
Clinical Development Strategy
The Phase 3 RECOVER study represents a critical component of Reviva's clinical development strategy for brilaroxazine. The inclusion of a 52-week open-label extension portion demonstrates the company's commitment to thoroughly evaluating both the short-term and long-term effects of the drug candidate in the target patient population.
Long-term safety and efficacy data are particularly important for schizophrenia treatments, as patients typically require lifelong management of their condition. The extended observation period allows researchers to assess durability of response, emergence of late-onset adverse events, and other factors relevant to chronic administration.
The SIRS Congress provides an ideal platform for presenting these findings, as it brings together leading researchers, clinicians, and industry representatives focused on advancing schizophrenia treatment and understanding. The scientific exchange facilitated by this meeting may help inform future development decisions for brilaroxazine and contribute to the broader field of schizophrenia research.
Additional details about the presentation and abstract can be found on the SIRS 2025 website.
