Reviva Pharmaceuticals Announces Intent to File an IND for Brilaroxazine in Psoriasis After Promising Preclinical Data

Brilaroxazine topical liposomal-gel formulation (brilaroxazine lipogel) demonstrated proof-of-concept efficacy in the imiquimod-induced psoriatic mouse model

IND submission for brilaroxazine lipogel in psoriasis expected in 2024

Reviva has filed composition of matter patent for brilaroxazine-lipogel and a separate patent for use in the treatment of psoriasis

Excerpt from the Press Release:

CUPERTINO, Calif., May 11, 2023 (GLOBE NEWSWIRE) — 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.

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