Benzinga | Apr 26, 2021 06:05AM EDT

Reviva Reports Phase 2 Clinical Trial Results for Acute Schizophrenia Met Endpoints For Safety And Efficacy In 234 Patients' And Met Primary Endpoint Of Reduction In Positive And Negative Syndrome Scale Total Score

Reviva Pharmaceuticals Holdings, Inc. (NASDAQ:RVPH) (along with its subsidiaries, "Reviva" or the "Company"), 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 the full details of its Phase 2 clinical trial for its lead drug candidate, RP5063 (brilaroxazine) for Acute Schizophrenia.

Brilaroxazine has a unique pharmacology profile against key serotonin (5-HT) and dopamine (D) receptors, which Reviva believes can modulate and stabilize the D/5-HT system. Brilaroxazine demonstrated high affinity and selectivity for key serotonin receptors (5-HT1A/2A/2B/7), as it is pharmacologically different from other antipsychotics through its combination of potent affinity and selectivity for target receptors implicated for schizophrenia and its comorbid symptoms.

In its randomized, double-blind, placebo-controlled, multicenter Phase 2 trial to assess the safety and efficacy of brilaroxazine in 234 subjects with acute exacerbation of schizophrenia or schizoaffective disorder, brilaroxazine met its primary endpoint, which was reduction in total Positive and Negative Syndrome Scale (PANSS) at the end of the treatment from baseline versus placebo. The drug candidate also met all safety endpoints including clinical, labs, body weight, prolactin, lipids, fasting glucose, and EKG. The PANSS total score was reduced by 20 points, a statistically significant treatment difference from the placebo. Brilaroxazine also mitigated positive symptoms and negative symptoms, and improved social functioning and cognition. Importantly, the FDA has agreed to consider a potential 'Superior Safety' label claim, if there is a positive outcome on a relevant endpoint in a pivotal Phase 3 clinical study in schizophrenia.