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Reviva Pharmaceuticals Announced Preclinical Efficacy Data on Brilaroxazine in IPF at the 2023 American Thoracic Society International Conference and Publication in Medical Research ArchivesBrilaroxazine, a novel serotonin-dopamine modulator with multifaceted activities has the potential to treat idiopathic pulmonary fibrosis (IPF) Brilaroxazine improved survival and lung function, and reduced lung fibrosis and inflammation in a bleomycin-induced rodent model of IPF U.S. FDA has granted Orphan Drug Designation to brilaroxazine for IPF indication CUPERTINO, Calif., May 25, 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 preclinical data on the novel serotonin-dopamine modulator brilaroxazine in idiopathic pulmonary fibrosis (IPF) at the 2023 American Thoracic Society (ATS) International Conference which took place in Washington, DC, USA, May 19-24, 2023. The Company also announced acceptance of this data for publication in Medical Research Archives. The ATS poster and online publication will be available at revivapharma.com/publications. “The improvement in survival and lung function, coupled with significant reduction in fibrosis and proinflammatory cytokines in the bleomycin-induced rodent model of IPF reinforces the multifaceted action of brilaroxazine,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. “This preclinical evaluation in IPF provides proof-of-concept support for the potential of brilaroxazine to treat pulmonary fibrosis and inflammation stemming from underlying dysfunction in serotonin signaling in the lung. Brilaroxazine has already received Orphan Drug Designation by the U.S. FDA for IPF.” Idiopathic pulmonary fibrosis (IPF) is a debilitating lung disease involving chronic inflammation and progressive alveolar fibrosis that leads to destroyed architecture, reduced capacity, impaired oxygenation, and declined function. While two treatments - Nintedanib (Ofev®) and Pirfenidone (Esbriet®) – have been approved by the Food and Drug Administration (FDA), the ability to address unmet needs is still limited by inadequate improvements in lung function decline, disease progression and survival rates. Most IPF patients suffer from chronic mental illness (e.g. depression, psychosis). Serotonin (5-HT) signaling plays a key role, via 5-HT2A/2B/7 receptors, in the vasoactive effect on pulmonary arteries and lung myofibroblast actions. Brilaroxazine displays a high affinity and functional activity for the 5-HT2A/2B/7 receptors and moderate affinity for the serotonin transporter. Brilaroxazine’s effects on vascular fibrosis (5-HT2B receptor), proliferation (5-H2A/2B receptor), relaxation (5-HT2A receptor), inflammation (5-HT7 receptor), and pro-inflammatory cytokines have created interest in the potential to treat IPF. Brilaroxazine was evaluated in a bleomycin (BLM)-induced rat model of IPF receiving either brilaroxazine 15 mg twice daily for 21 days starting at day 1 (BT) or at day 10 (BI). Key highlights from the poster presentation and publication support the potential of brilaroxazine to improve fibrosis and inflammation in rat model of IPF
IPF is a progressive, debilitating, and fatal lung disease that affects approximately 3 million people worldwide. IPF is characterized by inflammation and fibrosis of the lungs, hindering the ability to process oxygen and causing shortness of breath. Mortality from IPF is increasing steadily worldwide with a median survival time from diagnosis of 2-5 years. It is estimated that there will be between 28,000 and 65,000 deaths in Europe and between 13,000 and 17,000 deaths in the United States from IPF per year. Treatment involves either early referral for lung transplantation, palliative care, and clinical trials. Various interventions, including commonly used agents (e.g., corticosteroids and immunosuppressants), are limited and not supported in current guidelines. While two treatments - Nintedanib (Ofev®), and Pirfenidone (Esbriet®) – have been approved by the Food and Drug Administration (FDA), the ability to address unmet needs is still limited by inadequate improvements in lung function decline, disease progression and survival rates. Most patients with IPF suffer from chronic mental illness (e.g. depression, psychosis). About Brilaroxazine 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. About Reviva Forward-Looking Statements 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: Investor Relations Contact: RedChip Companies, Inc.
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