Biophytis Obtains IND Approval From the FDA to Start Its Phase 2 OBA Study in Obesity
Biophytis Obtains IND Approval From the FDA to Start Its Phase 2 OBA Study in Obesity
The multicenter study is due to start mid-2024 in the USA and could be extended to Europe. Preliminary results on the efficacy of BIO101 (20-hydroxyecdysone) are expected in 2025. Biophytis is seeking funding and partnerships to complete this study.PARIS, FRANCE AND CAMBRIDGE, MA / ACCESSWIRE / July 11, 2024 / Biophytis SA (Euronext Growth Paris:ALBPS), ("Biophytis" or the "Company"), a clinical-stage biotechnology company specialized in the development of therapeutics for age-related diseases, today announced that it has received Investigational New Drug (IND) approval from the Food and Drug Administration (FDA) for its phase 2 OBA clinical study in obesity with BIO101 (20-hydroxyecdysone).
2024年7月11日，法國巴黎和美國馬薩諸塞州劍橋 / ACCESSWIRE / Biophytis SA（Euronext Growth Paris:ALBPS），一家專門從事研發治療年齡相關疾病的臨床生物技術公司，今天宣佈，其BIO101（20-羥基蛻皮激素）用於肥胖的第2期OBA臨床研究已經獲得食品和藥物管理局（FDA）的新藥研究申請（IND）批准。
The primary objective of the study is to measure the improvement in muscle strength in the lower limbs, as assessed by knee extension test. Secondary endpoints will include analysis of mobility (via the 6-minute walk test) and body composition (assessment of fat and lean mass). A world-renowned medical expert in the field of obesity and President-elect of the American Obesity Society, Marc-André Cornier, Professor of Medicine and Director of the Endocrinology, Diabetes and Metabolic Diseases Unit at the Medical University of South Carolina, will be the principal investigator of the phase 2 OBA study.
該研究的主要目的是測量下肢肌肉力量的改善，通過膝關節伸展測試進行評估。次要終點包括分析活動度（通過6分鐘步行測試）和身體組成（評估脂肪和瘦肉量）。美國肥胖學領域的世界知名醫學專家，美國肥胖學會主席Marc-André Cornier，醫學教授，南卡羅來納醫科大學內分泌、糖尿病和代謝疾病科主任，將是第2期OBA研究的首席研究員。
Professor Marc-André Cornier commented: "I am very happy that the IND for the phase 2 OBA clinical study with BIO101 (20-hydroxyecdysone) has been approved by the FDA. It is critical for us to study the safety and efficacy of new therapies designed to reduce the risk of muscle mass loss and resulting muscle weakness with functional consequences that may be associated with incretin-based therapies. Additionally we might observe further weight loss over and above that obtainable with a GLP-1 RA."
Marc-André Cornier教授評論道：“我很高興FDA批准了BIO101（20-羥基蛻皮激素）在肥胖症第2期OBA臨床研究中的IND。對於我們來說，研究設計新療法的安全性和有效性以減少肌肉質量損失的風險，以及與腸肽類基於胰高血糖素樣肽-1受體激動劑相關的肌肉無力和力量功能的功能後果是至關重要的。此外，我們可能還會觀察到超過GLP-1 RA所能達到的進一步減輕體重。”
The multicenter study is due to start mid-2024 in the USA and could be extended to Europe. Preliminary results on the efficacy of BIO101 (20-hydroxyecdysone) are expected in 2025. Biophytis is seeking funding and partnerships to complete this study.
這項重心醫學研究將於2024年年中在美國啓動，並可能擴展到歐洲。有關BIO101（20-羥基蛻皮激素）的有效性的初步結果將於2025年公佈。Biophytis正在尋求資金和合作夥伴來完成這項研究。
Stanislas Veillet, CEO de Biophytis, stated: "Obesity represents a major medical challenge and a significant growth opportunity for Biophytis. The obesity treatment market, estimated at $6 billion in 2023, is expected to reach $100 billion by 2030, with an average annual growth rate of 42%. Obtaining an IND from the FDA is a crucial step that will enable us to make rapid progress in this indication and attract new pharmaceutical partners. We are convinced that BIO101 could become a reference treatment for preserving muscle mass, strength and function in obese patients treated with GLP-1 RAs. This development has convinced our partner Blanver in Latin America, and we are convinced that it will attract new ones in other regions of the world where obesity is a major health issue."
Biophytis的CEO Stanislas Veillet說：“肥胖症代表了一個重大的醫療挑戰和一個重要的增長機遇，Biophytis將從中受益。肥胖症治療市場在2023年估計爲60億美元，預計到2030年將達到1000億美元，平均年增長率爲42％。獲得FDA的IND是一個關鍵步驟，將使我們在這種情況下迅速取得進展並吸引新的製藥合作伙伴。我們相信，BIO101可以成爲肥胖症患者在GLP-1 RAs治療下維護肌肉質量、力量和功能的參考治療方法。這一發展已經使我們在拉丁美洲的合作伙伴Blanver深信不疑，我們相信它將吸引其他世界其他肥胖症患者的製藥公司的關注。
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About BIOPHYTIS
關於Biophytis
Biophytis SA is a clinical-stage biotechnology company specializing in the development of drug candidates for age-related diseases. BIO101 (20-hydroxyecdysone), our lead drug candidate, is a small molecule in development for muscular (sarcopenia, phase 3 ready and Duchenne muscular dystrophy, phase 1-2 study to be started, respiratory (Covid-19, phase 2 completed) and metabolic diseases (obesity, phase 2 to be started). The company is based in Paris, France, and Cambridge, Massachusetts. The Company's ordinary shares are listed on Euronext Growth (Ticker: ALBPS -ISIN: FR0012816825). For more information, visit
Biophytis SA是一家臨床生物技術公司，專注於開發面向年齡相關疾病的候選藥物。BIO101（20-羥基蛻皮激素）是我們的主導藥物候選藥物，是一種小分子藥物，用於肌肉（肌肉萎縮，第3期待啓動和杜興肌肉萎縮，第1-2期即將啓動）、呼吸（COVID-19，第2期已完成）和代謝性疾病（肥胖症，第2期將啓動）的研究。該公司總部位於法國巴黎和美國馬薩諸塞州的劍橋。公司普通股在Euronext Growth上市（Ticket：ALBPS - ISIN: FR0012816825）。了解更多信息，請訪問
Forward-looking statements
前瞻性聲明 本新聞稿中包括的關於未來表現和結果、預期、規劃、策略、重點、承諾和其他聲明（包括與我們社會、環境和其他可持續性目標有關的聲明）的非歷史事實的前瞻性聲明，是根據美國聯邦證券法的定義而作出的前瞻性聲明。本新聞稿中關於我們環境和其他可持續性計劃和目標的前瞻性聲明以及其他聲明並不意味着這些聲明對於投資者、我們的業務、運營結果、財務狀況、前景或策略、對我們在可持續發展事項上的影響或其他當事方來說均是重要的，或者必須披露在我們向證券交易委員會（“SEC”）或其他監管機構的備案中。此外，歷史、現有及未來涉及社會、環境和可持續性的相關聲明可能是基於仍在發展的衡量進展的標準、不斷演變的內部控制和流程以及假設，在將來可能會發生變化。前瞻性聲明基於當前的信仰、期望和假設，並受到可能導致實際結果與前瞻性聲明有實質性差異的重大風險、不確定性和情況變化的影響。
This press release contains forward-looking statements. Forward-looking statements include all statements that are not historical facts. In some cases, you can identify these forward-looking statements by the use of words such as "outlook," "believes," "expects," "potential," "continues," "may," "will," "should," "could," "seeks," "predicts," "intends," "trends," "plans," "estimates," "anticipates" or the negative version of these words or other comparable words. Such forward-looking statements are based on assumptions that Biophytis considers to be reasonable. However, there can be no assurance that the statements contained in such forward-looking statements will be verified, which are subject to various risks and uncertainties. The forward- looking statements contained in this press release are also subject to risks not yet known to Biophytis or not currently considered material by Biophytis. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. Please also refer to the "Risk and uncertainties the Company is to face» section from the Company's 2023 Financial Report available on BIOPHYTIS website () and as exposed in the "Risk Factors" section of form 20-F as well as other forms filed with the SEC (Securities and Exchange Commission, USA). We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.
本新聞稿包含前瞻性聲明。前瞻性聲明包括所有非歷史事實陳述。 在某些情況下，您可以通過使用“前景展望”，“相信”，“期望”，“潛力”，“繼續，”，“可能”，“將” ，“應該”，“可能”，“尋求”，“預測”，“打算”，“趨勢”，“計劃”，“估計”，“預計” 或這些詞的負面版本或其他可比較的詞語來識別這些前瞻性陳述。 這類前瞻性聲明是基於Biophytis認爲合理的假設。然而，不能保證這些前瞻性陳述中包含的陳述將得到證實，這些陳述還可能受到各種風險和不確定性的影響。此 新聞稿中包含的前瞻性聲明也可能受到 Biophytis 尚未了解或目前不認爲重要的風險的影響。因此，存在或將存在重要因素可能導致實際結果或成果與這些聲明中指示的結果存在重大差異。此外，請參閱 Biophytis 網站上可用的2023年財務報告中的“公司即將面臨的風險與不確定性”部分以及20-F表格中的“風險因素”部分以及提交給美國證券交易委員會（SEC）的其他表格。我們沒有義務公開更新或審查任何前瞻性聲明，無論是因爲新的信息，未來的發展還是其他情況，除非法律要求。
Biophytis contacts
Biophytis聯繫方式
Investor relations
投資者關係
Nicolas Fellmann, CFO
Investors@biophytis.com
Nicolas Fellmann，CFO
Investors@biophytis.com
Media
媒體
Antoine Denry:antoine.denry@taddeo.fr - +33 6 18 07 83 27
Nizar Berrada: nizar.berrada@taddeo.fr - +33 6 38 31 90 50
Antoine Denry：antoine.denry@taddeo.fr - +33 6 18 07 83 27
Nizar Berrada: nizar.berrada@taddeo.fr - +33 6 38 31 90 50
SOURCE: Biophytis
來源：Biophytis
譯文內容由第三人軟體翻譯。
