Reviva Pharmaceuticals
Reviva Pharmaceuticals develops next-generation therapeutics for diseases with significant unmet medical needs, focusing on central nervous system, respiratory, and metabolic diseases. Their lead drug candidate, brilaroxazine, is in clinical development for multiple neuropsychiatric indications and has shown promising results in clinical trials.
Company Overview
Reviva Pharmaceuticals develops next-generation therapeutics for diseases with significant unmet medical needs. The company focuses on discovering and developing novel therapies for central nervous system, respiratory, and metabolic diseases. Utilizing chemical genomics-driven technology, Reviva aims to bring new medicines to market to address these critical health issues.
Lead Drug Candidate: Brilaroxazine
Reviva Pharmaceuticals' lead drug candidate, brilaroxazine (RP5063), is in clinical development for multiple neuropsychiatric indications such as schizophrenia, bipolar disorder, major depressive disorder, behavior and psychotic symptoms in Alzheimer's disease, Parkinson's disease psychosis, and ADHD. Brilaroxazine has demonstrated nonclinical activity in inflammatory diseases like psoriasis, pulmonary arterial hypertension (PAH), and idiopathic pulmonary fibrosis (IPF), and has received Orphan Drug Designation by the U.S. FDA for PAH and IPF treatment.
Clinical Trials and Research
Reviva Pharmaceuticals successfully completed the pivotal Phase 3 RECOVER trial, evaluating the efficacy, safety, and tolerability of once-daily brilaroxazine in adults with schizophrenia. The trial met all primary and secondary endpoints, showing significant reductions in symptoms at week 4. Brilaroxazine is generally well tolerated in patients with acute and stable schizophrenia. The registrational RECOVER-2 trial is set to initiate in Q2 2024, with topline data expected in Q3 2025. The company presented Phase 3 RECOVER-1 clinical trial data at the 2024 Schizophrenia International Research Society (SIRS) and the American Society for Clinical Pharmacology & Therapeutics (ASCPT) Annual Meetings.
Pipeline Products
Reviva Pharmaceuticals has a robust pipeline that includes two key drug candidates: brilaroxazine (RP5063) and RP1208, both discovered in-house. The company has secured composition of matter patents for these drugs in the United States, Europe, and other countries. Brilaroxazine is undergoing clinical trials for several indications, with potential Phase 2a studies for bipolar disorder, major depressive disorder, and ADHD anticipated in 2024. Additionally, an investigational new drug application (IND) for a liposomal-gel formulation of brilaroxazine for psoriasis is expected in 2025.
Business Strategy and Partnerships
Reviva Pharmaceuticals actively pursues partnerships and collaborations to further develop its pipeline. The company evaluates grant and other non-dilutive financing opportunities from Federal and State Healthcare Agencies and Foundations to support its product candidates. This strategic approach aims to accelerate the development and commercialization of its novel therapies for various diseases representing significant unmet medical needs.