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Biophytis Presented Its Phase 3 Protocol in the Treatment of Sarcopenia

Biophytis Presented Its Phase 3 Protocol in the Treatment of Sarcopenia

Biophytis介紹了其治療肌肉減少症的3期方案
Accesswire ·  03/22 02:20

PARIS, FRANCE and CAMBRIDGE, MA / ACCESSWIRE / March 22, 2024 / Biophytis SA (Nasdaq:BPTS)(Euronext Growth Paris:ALBPS), ("Biophytis" or the "Company"), a clinical-stage biotechnology company specialized in the development of therapeutics that are aimed at slowing the degenerative processes associated with aging and improving functional outcomes for patients suffering from age-related diseases, presented its phase 3 protocol aimed at demonstrating the potential of RuvembriTM (20-hydroxyecdysone) in the treatment of sarcopenia at the International Conference on Frailty and Sarcopenia Research (ICFSR), held from March 20 to 22, 2024 in Albuquerque, NM, USA.

法國巴黎和馬薩諸塞州劍橋/ ACCESSWIRE/2024年3月22日/ Biophytis SA(納斯達克股票代碼:BPTS)(泛歐交易所增長巴黎:ALBPS)(“Biophytis” 或 “公司”)是一家臨床階段的生物技術公司,專門開發旨在減緩與衰老相關的退行過程和改善年齡相關疾病患者功能預後的療法,現已進入其階段 3項協議旨在在國際會議上證明RuvemBRITM(20-羥基壞死松)治療肌肉減少症的潛力虛弱和肌肉減少症研究(ICFSR),於2024年3月20日至22日在美國新墨西哥州阿爾伯克基舉行。

The SARA-INT phase 2 study showed promising results on physical performance, with significant improvement in the 400 Meter Walking Test, reaching 0.07 m/s in the Full Analysis Set population and 0.09 m/s in the Per Protocol population. This outcome was replicated in pre-defined sub-populations at higher risk of mobility disability. Based on outcome of the SARA-INT phase 2 study and on results from the SPRINTT and LIFE studies, Biophytis designed an interventional, randomized, double-blind, placebo-controlled clinical phase 3 study (the SARA-31 study), expected to include 932 subjects. The poster presented at the ICFSR conference, which details the objectives and the design of the study, can be viewed by clicking on this link.

SARA-INT 第 2 期研究顯示出令人鼓舞的身體表現結果,400 米步行測試顯著改善,全分析集群達到了 0.07 m/s,按協議人群達到了 0.09 m/s。這一結果在行動障礙風險較高的預定義亞群中複製。根據SARA-INT 2期研究的結果以及SPRINTT和LIFE研究的結果,Biophytis設計了一項介入性、隨機、雙盲、安慰劑對照的3期臨床研究(SARA-31 研究),預計將包括932名受試者。在ICFSR會議上發佈的海報詳細介紹了該研究的目標和設計,可以通過點擊此處查看 鏈接

Stanislas Veillet, CEO of Biophytis, stated: "The SARA-31 phase 3 study will assess the efficacy and safety of RuvembriTM in the treatment of sarcopenic patients at risk of functional decline and disability. After receiving approval to initiate the study in Belgium and the United States, our drug candidate appears to be the most advanced in this indication and we are actively searching for pharmaceutical partners to develop it and finance its market access."

Biophytis首席執行官斯坦尼斯拉斯·維耶特表示:“SARA-31 3期研究將評估RuvemBritm在治療有功能衰退和殘疾風險的肌肉減少患者方面的療效和安全性。在獲得批准在比利時和美國啓動這項研究後,我們的候選藥物似乎是該適應症中最先進的藥物,我們正在積極尋找藥物合作伙伴來開發該藥物併爲其市場準入提供資金。”

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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. RuvembriTM, our lead drug candidate, is a small molecule in development for age-related neuromuscular (sarcopenia and Duchenne muscular dystrophy) and cardiorespiratory (Covid-19) diseases. Promising clinical results were obtained in the treatment of sarcopenia in an international phase 2 study, enabling the launch of a phase 3 study in this indication (SARA project). The safety and efficacy of RuvembriTM in the treatment of severe COVID-19 were studied in a positive international phase 2-3 clinical trial (COVA project). A pediatric formulation of RuvembriTM is currently being developed for the treatment of Duchenne Muscular Dystrophy (DMD, MYODA project). 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 Nasdaq Capital Market (Ticker BPTS - ISIN: US09076G1040). 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。我們的主要候選藥物RuvemBritm是一種正在開發的小分子,用於治療與年齡相關的神經肌肉疾病(肌肉減少症和杜興氏肌肉萎縮症)和心肺疾病(Covid-19)。一項國際2期研究在治療肌肉減少症方面取得了令人鼓舞的臨床結果,從而啓動了該適應症的3期研究(SARA項目)。一項積極的國際2-3期臨床試驗(COVA項目)研究了RuvemBritm治療重症 COVID-19 的安全性和有效性。目前正在開發一種RuvemBritm的兒科配方,用於治療杜興氏肌肉萎縮症(DMD,MYODA項目)。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)在納斯達克資本市場(股票代碼BPTS——ISIN:US09076G1040)上市。欲了解更多信息,請訪問

Disclaimer

免責聲明

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 2022 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,這些陳述受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2022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
Nicolas Fellmann, CFO
Investors@biophytis.com

投資者關係
尼古拉斯·費爾曼,首席財務官
Investors@biophytis.com

Media
Antoine Denry:antoine.denry@taddeo.fr - +33 6 18 07 83 27
Nizar Berrada: nizar.berrada@taddeo.fr - +33 6 38 31 90 50

媒體
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


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