Friday, December 16, 2022
Reviva Pharmaceuticals Holdings, Inc., a clinical-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), cardiovascular, metabolic, and inflammatory diseases, today announced positive data from its recently completed clinical drug-drug interaction (DDI) study investigating the potential effect of CYP3A4 enzyme on brilaroxazine in healthy subjects. The CYP3A4 enzyme plays a pivotal role in helping the body metabolize and remove small foreign molecules and is primarily found in the liver and intestine. DDI evaluation is a critical clinical pharmacology study required by the U.S. Food and Drug Administration (FDA) and other regulatory agencies globally for approving a new drug to market. Brilaroxazine is a serotonin/dopamine modulator in late-stage clinical development for the treatment of schizophrenia.
“We are pleased to have achieved positive results from our DDI study with brilaroxazine, which further demonstrated its differentiated pharmacological and safety profile. Our latest data reinforce that brilaroxazine may have the potential to provide an advantage over other treatments for patients taking multiple drugs who are at higher risk of experiencing adverse drug interactions or even discontinuation of their medications due to those interactions,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO. “We look forward to submitting these data to the FDA along with the results from our pivotal Phase 3 trials as part of our New Drug Application (NDA) for brilaroxizine in schizophrenia.”
Following FDA guidelines, the DDI clinical study was designed to evaluate the drug interaction effect of a strong CYP3A4 inhibitor or inducer when co-administered with brilaroxazine in healthy volunteers. A strong CYP3A4 inhibitor, itraconazole, slightly increased brilaroxazine Cmax, AUClast and AUCinf by 6, 16 and 13%, respectively, in healthy volunteers (N=11). Similarly, a strong CYP3A4 inducer, phenytoin, in healthy volunteers (N=16) decreased brilaroxazine Cmax, AUClast and AUCinf by 33, 56 and 53%, respectively. Reviva believes that brilaroxazine's clinical safety is further reinforced with the positive results of this DDI study, which found no clinically significant interaction when combined with a CYP3A4 inhibitor.
Brilaroxazine is currently being evaluated in RECOVER, a pivotal global Phase 3, randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of brilaroxazine in approximately 400 patients with acute schizophrenia compared to placebo. Brilaroxazine will be administered at fixed doses of 15 mg or 50 mg once daily for 28 days. A 52-week open-label extension study with flexible doses of 15 mg, 30 mg, or 50 mg will further evaluate the long-term safety and tolerability of brilaroxazine in patients with stable schizophrenia. Topline data is expected in mid-2023.
