– Schizophrenia late-stage clinical program advances with positive topline Phase 3 data, successful ongoing enrollment in open label extension (OLE) trial, and positive drug-drug interaction data supporting a differentiated profile for once-daily brilaroxazine –
– Initiation of registrational Phase 3 RECOVER-2 trial expected Q1 2024 –
– Topline data from 1-year OLE trial expected Q4 2024 –
CUPERTINO, Calif., Jan. 04, 2024 (GLOBE NEWSWIRE) — Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today provided program updates and announced upcoming key milestones.
“In 2023, we made significant progress across our late-stage brilaroxazine clinical program in schizophrenia, including positive topline Phase 3 data demonstrating statistically significant reductions across all major symptom domains, successful ongoing enrollment in our one-year OLE trial, and positive clinical drug-drug interaction data supporting a competitive profile for once-daily brilaroxazine,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. “We also furthered foundational preclinical support for the therapeutic potential of brilaroxazine in other inflammatory conditions driven by underlying serotonin signaling dysfunction, including psoriasis and idiopathic pulmonary fibrosis (IPF). We believe these advances reinforce the broad potential of brilaroxazine to be a safe and effective therapy for major neuropsychiatric and inflammatory indications caused by a dysfunctional serotonin-dopamine system. Importantly, our recent progress brings us closer than ever to fulfilling our mission of reviving the full promise of patients’ lives with treatment paradigm changing drugs targeting neurotransmitter-driven diseases. As we look ahead, we expect 2024 will be a pivotal year for Reviva as we continue the momentum in schizophrenia with topline data from our OLE trial expected in the fourth quarter of 2024 and initiation of a registrational Phase 3 RECOVER-2 trial expected in the first quarter of 2024. Collectively, these data are designed to support our New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA), expected in 2025.”
Pipeline Program Updates
Brilaroxazine – A once-daily, serotonin-dopamine signaling modulator
Schizophrenia Program
Psoriasis Program
Pulmonary Program
Corporate Update
Anticipated Milestones and Events
About Brilaroxazine
Brilaroxazine is an in-house discovered new chemical entity with potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms. Positive topline data from the global Phase 3 RECOVER trial in schizophrenia demonstrated the trial successfully met all primary and secondary endpoints with statistically significant and clinically meaningful reductions across all major symptom domains at week 4 with 50 mg of brilaroxazine vs. placebo with a generally well-tolerated side effect profile comparable to placebo and discontinuation rates lower than placebo. Positive data from a clinical drug-drug interaction (DDI) study investigating the potential effect of CYP3A4 enzyme on brilaroxazine in healthy subjects supports no clinically significant interaction when combined with a CYP3A4 inhibitor. Reviva believes that a full battery of regulatory compliant toxicology and safety pharmacology studies has been completed for brilaroxazine. Reviva intends to develop brilaroxazine for other neuropsychiatric indications including bipolar disorder, major depressive disorder (MDD) and attention-deficit/hyperactivity disorder (ADHD).
Additionally, brilaroxazine has shown promising nonclinical activity for inflammatory diseases psoriasis, pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF) with mitigation of fibrosis and inflammation in translational animal models. Brilaroxazine has already received Orphan Drug Designation by the U.S. FDA for the treatment of PAH and IPF conditions.
To learn more about the clinical and preclinical data available for brilaroxazine, please visit revivapharma.com/publications.
About Reviva
Reviva is a late-stage biopharmaceutical company that discovers, develops, and seeks to commercialize next-generation therapeutics for diseases representing unmet medical needs and burdens to society, patients, and their families. Reviva’s current pipeline focuses on the central nervous system, respiratory and metabolic diseases. Reviva’s pipeline currently includes two drug candidates, brilaroxazine (RP5063) and RP1208. Both are new chemical entities discovered in-house. Reviva has been granted composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries.
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act, as amended, including those relating to the Company’s 1-year open label extension (OLE) trial evaluating the long-term safety and tolerability for brilaroxazine in schizophrenia, the registrational Phase 3 RECOVER-2 trial, the Company’s expectations regarding the anticipated clinical profile of its product candidates, including statements regarding anticipated efficacy or safety profile, and those relating to the Company’s expectations, intentions or beliefs regarding matters including product development, clinical and regulatory timelines and expenses, planned or additional studies, planned or intended regulatory submissions, market opportunity, ability to raise sufficient funding, competitive position, possible or assumed future results of operations, business strategies, potential opportunities for development including partnerships, growth or expansion opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.
These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential, “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2022, and the Company’s other filings from time to time with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Corporate Contact:
Reviva Pharmaceuticals Holdings, Inc.
Laxminarayan Bhat, PhD
www.revivapharma.com
Investor Relations Contact:
LifeSci Advisors, LLC
Bruce Mackle
bmackle@lifesciadvisors.com
Media Contact:
Kristin Politi
kpoliti@lifescicomms.com
(646) 876-4783
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