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Reviva to Present New Preclinical Efficacy Data on Brilaroxazine in Idiopathic Pulmonary Fibrosis at 2024 ATS International Conference

Reviva to Present New Preclinical Efficacy Data on Brilaroxazine in Idiopathic Pulmonary Fibrosis at 2024 ATS International Conference

Reviva將在2024年ATS國際會議上發佈有關Brilaroxazine治療特發性肺纖維化的新臨床前療效數據
Reviva Pharmaceuticals ·  05/13 00:00

CUPERTINO, Calif., May 13, 2024 — 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 announced that Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva, will present new efficacy data on brilaroxazine in an animal model of idiopathic pulmonary fibrosis as part of a late-breaking poster presentation at the 2024 American Thoracic Society (ATS) International Conference, to be held in San Diego, CA, May 17-22, 2024.

加利福尼亞州庫比蒂諾,2024年5月13日——Reviva Pharmicals Holdings, Inc.(納斯達克股票代碼:RVPH)(“Reviva” 或 “公司”)是一家開發旨在解決中樞神經系統(CNS)、炎症和心臟代謝疾病領域未得到滿足的醫療需求的療法的後期製藥公司,今天宣佈,Laxminarayan Bhat博士,創始人、總裁兼首席執行官作爲2024年美國胸科學會最新海報展示的一部分,Reviva將在特發性肺纖維化動物模型中展示brilaroxazine的新療效數據協會(ATS)國際會議,將於2024年5月17日至22日在加利福尼亞州聖地亞哥舉行。

Details for the poster presentation can be found below:

海報展示的詳細信息可以在下面找到:

Title: Effectiveness of brilaroxazine on functional and underlying pathological inflammation and fibrosis parameters in bleomycin-induced idiopathic pulmonary fibrosis model using male sprague dawley rats
Poster Number: 15059
Session (C73): Thematic Poster Session – Preclinical modeling of pulmonary inflammation and emphysema
Date: Tuesday, May 21, 2024
Time: 9:15am – 4:15pm PT
Presenter: Laxminarayan Bhat, Reviva Pharmaceuticals
Location: San Diego Convention Center, San Diego, CA

標題:brilaroxazine對使用雄性sprague dawley大鼠的博來黴素誘導的特發性肺纖維化模型中功能和潛在病理炎症和纖維化參數的有效性
海報編號:15059
會議(C73):主題海報會議 — 肺部炎症和肺氣腫的臨床前建模
日期:2024 年 5 月 21 日,星期二
時間:太平洋時間上午 9:15 — 下午 4:15
主持人:Reviva 製藥公司的 Laxminarayan Bhat
地點:加利福尼亞州聖地亞哥的聖地亞哥會議中心

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).

關於 brilarozazine
Brilaroxazine 是一種內部發現的新化學物質,對與精神分裂症及其合併症狀相關的關鍵血清素和多巴胺受體具有很強的親和力和選擇性。來自精神分裂症全球3期RECOVER試驗的正面數據表明,該試驗成功地達到了所有主要和次要終點,在第4周所有主要症狀領域均有統計學意義和臨床意義的降低,與安慰劑相比,其副作用總體耐受性良好,停藥率低於安慰劑,停藥率低於安慰劑。一項臨床藥物相互作用 (DDI) 研究的陽性數據顯示,與 CYP3A4 抑制劑聯合使用時,CYP3A4 酶對健康受試者的潛在影響不會產生臨床顯著的相互作用。Reviva認爲,brilarozazine已經完成了一整套符合監管要求的毒理學和安全藥理學研究。Reviva打算開發用於其他神經精神適應症的brilarozazine,包括躁鬱症、重度抑鬱症(MDD)和注意力缺陷/多動障礙(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.

此外,brilaroxazine在炎症性疾病牛皮癬、肺動脈高壓(PAH)和特發性肺纖維化(IPF)方面顯示出有前景的非臨床活性,可緩解轉化動物模型中的纖維化和炎症。Brilaroxazine已獲得美國食品藥品管理局頒發的用於治療多環芳烴和IPF疾病的孤兒藥稱號。

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

要了解有關brilaroxazine的臨床和臨床前數據的更多信息,請訪問 revivapharma.com/出版物

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.

關於 Reviva
Reviva是一家處於後期階段的生物製藥公司,致力於發現、開發下一代療法,並尋求將這些療法商業化,用於治療醫療需求未得到滿足的疾病,給社會、患者及其家庭帶來負擔。Reviva目前的產品線側重於中樞神經系統、呼吸和代謝疾病。Reviva的產品線目前包括兩種候選藥物,即brilaroxazine(RP5063)和 RP1208。兩者都是內部發現的新化學實體。Reviva 已在美國、歐洲和其他幾個國家獲得了 brilaroxazine 和 RP1208 的物質成分專利。

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.

前瞻性陳述
本新聞稿包含1933年《證券法》第27A條和經修訂的《1934年證券交易法》第21E條和經修訂的《私人證券訴訟改革法》所指的某些前瞻性陳述,包括與公司評估精神分裂症患者brilaroxazine長期安全性和耐受性的1年開放標籤延期(OLE)試驗、註冊性第三階段 RECOVER-2 試驗、公司對其候選產品的預期臨床概況,包括有關預期療效或安全概況的聲明,以及與公司在產品開發、臨床和監管時間表和開支、計劃或額外研究、計劃或計劃提交的監管文件、市場機會、籌集足夠資金的能力、競爭地位、可能或假設的未來經營業績、業務戰略、包括合作伙伴關係、增長或擴張機會在內的潛在發展機會等方面的預期、意圖或信念相關的聲明本質上是預測性的陳述。這些前瞻性陳述基於當前對我們經營的行業和市場的預期、估計、預測和預測以及管理層當前的信念和假設。

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, 2023, 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.

這些陳述可以通過使用前瞻性表達來識別,包括但不限於 “期望”、“預期”、“打算”、“計劃”、“相信”、“估計”、“潛力”、“預測”、“項目”、“應該”、“將” 和類似的表述以及這些術語的否定詞。這些陳述與未來事件或我們的財務業績有關,涉及已知和未知的風險、不確定性和其他因素,這些因素可能導致實際業績、業績或成就與前瞻性陳述所表達或暗示的任何未來業績、業績或成就存在重大差異。這些因素包括公司最新的截至2023年12月31日財年的10-K表年度報告中列出的因素,以及公司不時向美國證券交易委員會提交的其他文件。提醒潛在投資者不要過分依賴此類前瞻性陳述,這些陳述僅代表截至本新聞稿發佈之日。公司沒有義務公開更新任何前瞻性陳述,無論是由於新信息、未來事件還是其他原因。

Corporate Contact:
Reviva Pharmaceuticals Holdings, Inc.
Laxminarayan Bhat, PhD
www.revivapharma.com

公司聯繫人:
Reviva 製藥控股有限公司
Laxminarayan Bhat,博士
www.revivapharma.com

Investor Relations Contact:
LifeSci Advisors, LLC
Bruce Mackle
bmackle@lifesciadvisors.com

投資者關係聯繫人:
LifeSci 顧問有限公司
布魯斯·麥克爾
bmackle@lifesciadvisors.com

Media Contact:
Kristin Politi
kpoliti@lifescicomms.com
(646) 876-4783

媒體聯繫人:
克里斯汀·波利蒂
kpoliti@lifescicomms.com
(646) 876-4783

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声明:本內容僅用作提供資訊及教育之目的,不構成對任何特定投資或投資策略的推薦或認可。 更多信息
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