First-in-Human – Phase 3 for new Schizophrenia treatment.

Reviva anticipates expanding the clinical development of brilaroxazine into other neuropsychiatric indications.
Schizophrenia

New Treatment for Schizophrenia.

Reviva Pharmaceuticals, 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, announced today that the first patients have been dosed in a pivotal Phase 3 study and long-term safety trial to assess Reviva’s new chemical entity brilaroxazine for the treatment of subjects with an acute exacerbation of schizophrenia.

“We are pleased to announce dosing of the first patients in our pivotal, global Phase 3 RECOVER trial with registrational intent. Schizophrenia is a complex disorder that affects approximately 1% of the world’s population. Despite this high prevalence, current treatment challenges remain, including suboptimal efficacy, poor tolerability, and low patient adherence. We believe that the clinical data to date supports the potential of brilaroxazine to help patients suffering from schizophrenia,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva.

“Following the success of our Phase 2 study in schizophrenia, we expect to expand clinical development of brilaroxazine into other neuropsychiatric indications including bipolar disorder, major depressive disorder (MDD) and attention-deficit/hyperactivity disorder (ADHD) in 2022.”

Schizophrenia

RECOVER is a 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 will further evaluate the long-term safety and tolerability of brilaroxazine in patients with stable schizophrenia. Reviva initiated the first clinical site in Bentonville, Arkansas with two patients dosed at the Pillar Clinical trial site led by its principal investigator, Dr. Fayz A. Hudefi, M.D.

Fayz Hudefi, M.D. added, “It is clear there is a void of treatment options for patients battling schizophrenia, and a large unmet need exists for a long-term tolerable treatment that can effectively address schizophrenia. We are excited to be part of the pivotal clinical trial for brilaroxazine as we dose the first patients in the global Phase 3 RECOVER trial designed to build upon Reviva’s positive Phase 2 study. We remain highly encouraged by the therapeutic potential of brilaroxazine and the potential it holds to help patients and their families in need of a durable solution.

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