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Reviva Pharmaceuticals (RVPH) Intends to File an IND for Brilaroxazine in Psoriasis After Promising Preclinical Data

May 11, 2023 6:30 AM

Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“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), respiratory and metabolic diseases, has presented promising preclinical data on the potential of novel serotonin-dopamine stabilizer brilaroxazine for the treatment of psoriasis at the First International Societies for Investigative Dermatology (ISID) Meeting in Tokyo, Japan, May 10-13, 2023. The ISID poster is available at revivapharma.com/publications.

“The multifaceted activity of brilaroxazine offers the promise to improve the quality of life and provide a novel treatment option for patients with psoriasis, an inflammatory condition stemming from serotonin and dopamine dysfunction,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. “We were excited to present encouraging preclinical data at ISID 2023 highlighting the therapeutic potential of brilaroxazine lipogel, a novel, proprietary lipogel formulation for the topical treatment of psoriasis. We have filed a composition of matter patent for brilaroxazine-lipogel and a separate patent for its use in psoriasis. Mental illness, including schizophrenia and depression, is a major comorbidity in patients with psoriasis. Brilaroxazine has established a well-tolerated safety profile with robust efficacy in about 300 patients with schizophrenia from Phase 1B and Phase 2 studies. To further explore this therapeutic potential, we intend to submit an investigational new drug application (IND) for brilaroxazine lipogel in psoriasis in 2024.”

Psoriasis is a chronic dermal inflammatory disease with a global prevalence of ~125 million. Dopamine (D) and serotonin (5-HT) signaling pathways play an important role in the pathobiology of psoriasis, and lead to increased inflammatory mediators (TNF-α, IFN-γ, IL-1β, IL-6, IL-8), keratinocyte activation and deterioration, and worsening symptoms. Current treatments include multiple modalities but are limited by long-term side effects (topicals), toxicities (orals) or risk of immunogenicity, serious infection, and malignancy (biologics). Brilaroxazine (RP5063) is a modulator of D and 5-HT receptors with multifaceted activity that may affect underlying psoriasis pathology. Preclinical studies in the imiquimod-induced psoriatic mouse model (BALB/c) were used to evaluate the potential of topical liposomal-gel formulation of brilaroxazine for the treatment of psoriasis.

Key poster highlights support the therapeutic potential of brilaroxazine lipogel in psoriasis:

About Reviva’s Lead Drug Candidate Brilaroxazine Brilaroxazine is a new chemical entity with potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms. In a multinational, multicenter, double-blind Phase 2 study in 234 patients with acute schizophrenia or schizoaffective disorder, brilaroxazine met its primary endpoint, reducing Positive and Negative Syndrome Scale (PANSS) total score and demonstrating statistically significant improvement of overall drug treatment outcomes using Clinical Global Impression (CGI) scale and for secondary endpoints evaluating social functioning, and positive and negative symptoms, and directional improvements for depression and cognition. In this completed Phase 2 study, brilaroxazine met all safety endpoints with no weight gain, no increase in blood sugar and lipids, and no cardiac or endocrine adverse effects compared to 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. A full battery of regulatory compliant toxicology and safety pharmacology studies has been completed for brilaroxazine. The U.S. Food and Drug Administration (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 study in patients with schizophrenia. 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 efficacy for pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF) with mitigation of lung fibrosis and inflammation in translational animal models. Reviva believes brilaroxazine has the potential to delay disease progression in PAH and IPF and intends to develop brilaroxazine for these pulmonary indications. Brilaroxazine has already received Orphan Drug Designation by the U.S. FDA for the treatment of these conditions.

To learn more about the clinical and preclinical data available for brilaroxazine, please visit revivapharma.com/publications.


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