Biophytis Announces the Design of Its Phase 2 OBA Clinical Study in Obesity
Biophytis Announces the Design of Its Phase 2 OBA Clinical Study in Obesity
PARIS, FRANCE and CAMBRIDGE, MA / ACCESSWIRE / May 14, 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 announces the design of its phase 2 OBA clinical study in obesity with BIO101 (20-hydroxyecdysone).
法國巴黎和馬薩諸塞州劍橋/ACCESSWIRE/2024年5月14日/專門從事年齡相關疾病療法開發的臨床階段生物技術公司Biophytis SA（泛歐交易所巴黎股票代碼：ALBPS）（“Biophytis” 或 “公司”）今天宣佈設計其針對肥胖的2期OBA臨床研究，該研究採用了 BIO101（20-羥基改松）。
BIO101 (20-hydroxyecdysone) will be evaluated in obese patients treated with GLP-1 RAs, together with hypocaloric dieting. The OBA phase 2 study will test the efficacy and safety of BIO101 (20-hydroxyecdysone) in patients with obesity and overweight with secondary comorbidities, who are starting treatment with GLP-1 RAs for weight loss.
將在接受 GLP-1 RA 和低熱量節食治療的肥胖患者中評估 BIO101（20-羥基腐皮酮）。OBA 第 2 期研究將測試 BIO101（20-羥基ecdysone）對肥胖和超重患有繼發合併症的患者的療效和安全性，這些患者已開始使用 GLP-1 RA進行減肥治療。
Stanislas Veillet, CEO of Biophytis, stated: "It is crucial for Biophytis to position itself on this gigantic medical challenge which also presents a great potential market. We believe BIO101 (20-hydroxyecdysone) has the potential to be the molecule of choice for preserving muscle function in patients suffering from obesity who are treated for weight loss with GLP-1 RAs. We are confident that our drug candidate,subject to regulatory approvals, could enter into a phase 2 clinical trial mid 2024 and that first results could be reported in 2025".
Biophytis首席執行官Stanislas Veillet表示：“對於Biophytis來說，應對這一巨大的醫療挑戰至關重要，這也是一個巨大的潛在市場。我們認爲，BIO101（20-羥基ecdysone）有可能成爲使用 GLP-1 RA 減肥治療的肥胖患者保持肌肉功能的首選分子。我們相信，我們的候選藥物如果獲得監管部門的批准，可能會在2024年中期進入2期臨床試驗，並且第一批結果可能會在2025年公佈”。
The OBA Phase 2 study is a double-blind, randomized, placebo-controlled clinical study in which 164 patients are planned to be enrolled with obesity (BMI ≥30) or overweight (BMI ≥27 with one or more sequalae e.g. diabetes, hypertension) at the start of treatment with GLP-1 RAs in combination with hypocaloric diet. Double-blind treatment with 350 mg BID of BIO101 (20-hydroxyecdysone) will be given for 21 weeks.
OBA 2 期研究是一項雙盲、隨機、安慰劑對照的臨床研究，計劃在開始使用 GLP-1 RA 與低熱量飲食聯合治療時，計劃招收 164 名肥胖（BMI ≥30）或超重（BMI ≥27，伴有一種或多種後遺症，例如糖尿病、高血壓）的患者。將使用 350 mg BID 的 BIO101（20-羥基艾迪松）進行爲期 21 周的雙盲治療。
The primary efficacy endpoint is muscle strength as measured by knee extension, and important secondary outcomes include 6 Minute Walking Distance and other performance tests, muscle strength normalized to lean body mass, appendicular lean mass and fat mass, biomarkers and various Patient-Reported Outcomes (PROs).
主要療效終點是通過膝關節伸展測量的肌肉力量，重要的次要結果包括6分鐘步行距離和其他性能測試、正常至瘦體重的肌肉力量、闌尾瘦體重和脂肪量、生物標誌物和各種患者報告結果（PROs）。
Biophytis is preparing for filing an Investigational New Drug (IND) to start the OBA Phase 2 study in the USA in the coming weeks.
Biophytis正準備申請一項研究性新藥（IND），以便在未來幾周內在美國啓動OBA 2期研究。
The OBA Phase 2 clinical study is expected to start mid 2024, upon regulatory approvals, with first patients expected to be treated in the second half of 2024.
經監管部門批准，OBA 2期臨床研究預計將於2024年中期開始，首批患者預計將在2024年下半年接受治療。
First results of the safety and efficacy of BIO101 (20-hydroxyecdysone) drug candidate are expected to be available in 2025.
BIO101（20-羥基改松）候選藥物的安全性和有效性的初步結果預計將於2025年公佈。
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About BIOPHYTIS
關於 BIOPYTIS
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), respiratory (Covid-19 phase 2-3 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) and the ADSs (American Depositary Shares) are listed on OTC market (Ticker: BPTSY - ISIN: US09076G4010). For more information, visit
Biophytis SA是一家臨床階段的生物技術公司，專門開發年齡相關疾病的候選藥物。BIO101（20-羥基壞死松）是我們的主要候選藥物，是一種正在開發的小分子，用於肌肉疾病（肌肉減少症，3期就緒和杜氏肌肉萎縮症）、呼吸系統（Covid-19階段2-3期已完成）和代謝性疾病（肥胖，第二階段即將開始）。該公司總部位於法國巴黎和馬薩諸塞州劍橋。該公司的普通股在泛歐交易所Growth上市（股票代碼：ALBPS-ISIN：FR0012816825），ADS（美國存托股）在場外交易市場上市（股票代碼：BPTSY——ISIN：US09076G4010）。欲了解更多信息，請訪問
Forward-looking statements
前瞻性陳述
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陳述。前瞻性陳述包括所有非歷史事實的陳述。在某些情況下，你可以使用諸如 “展望”、“相信”、“預期”、“潛力”、“繼續”、“可能”、“應該”、“可能”、“尋求”、“預測”、“打算”、“趨勢”、“計劃”、“估計”、“預期” 等詞語或這些詞語的負面版本或其他類似詞語來識別這些前瞻性陳述。此類前瞻性陳述基於Biophytis認爲合理的假設。但是，無法保證此類前瞻性陳述中包含的陳述會得到證實，這些陳述會受到各種風險和不確定性的影響。本新聞稿中包含的前瞻性陳述也受到Biophytis尚未知悉或Biophytis目前未被視爲材料的風險的影響。因此，有或將來會有一些重要因素可能導致實際結果或結果與這些陳述中所示的結果或結果存在重大差異。另請參閱公司2023年財務報告中的 “公司將面臨的風險和不確定性” 部分，該部分可在BIOPHYTIS網站上查閱（），20-F表格的 “風險因素” 部分以及向美國證券交易委員會（美國證券交易委員會）提交的其他表格。除非法律要求，否則我們沒有義務公開更新或審查任何前瞻性陳述，無論是由於新信息、未來發展還是其他原因。
Biophytis contacts
生物體炎接觸者
Investor relations
投資者關係
Nicolas Fellmann, CFO
Investors@biophytis.com
尼古拉斯·費爾曼，首席財務官
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
安託萬·丹利：antoine.denry@taddeo.fr-+33 6 18 07 83 27
尼扎爾·貝拉達： 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。