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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

Biophytis宣布其肥胖症的2期OBA临床研究的设计
Accesswire ·  05/14 01:20

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).

法国巴黎和马萨诸塞州剑桥/ACCESSWIRE/2024年5月14日/专门从事年龄相关疾病疗法开发的临床阶段生物技术公司Biophytis SA(泛欧交易所巴黎股票代码:ALBPS)(“Biophytis” 或 “公司”)今天宣布设计其针对肥胖的2期OBA临床研究,该研究采用了 BIO101(20-羟基改松)。

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.

将在接受 GLP-1 RA 和低热量节食治疗的肥胖患者中评估 BIO101(20-羟基腐皮酮)。OBA 第 2 期研究将测试 BIO101(20-羟基ecdysone)对肥胖和超重患有继发合并症的患者的疗效和安全性,这些患者已开始使用 GLP-1 RA进行减肥治疗。

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首席执行官Stanislas Veillet表示:“对于Biophytis来说,应对这一巨大的医疗挑战至关重要,这也是一个巨大的潜在市场。我们认为,BIO101(20-羟基ecdysone)有可能成为使用 GLP-1 RA 减肥治疗的肥胖患者保持肌肉功能的首选分子。我们相信,我们的候选药物如果获得监管部门的批准,可能会在2024年中期进入2期临床试验,并且第一批结果可能会在2025年公布”。

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 期研究是一项双盲、随机、安慰剂对照的临床研究,计划在开始使用 GLP-1 RA 与低热量饮食联合治疗时,计划招收 164 名肥胖(BMI ≥30)或超重(BMI ≥27,伴有一种或多种后遗症,例如糖尿病、高血压)的患者。将使用 350 mg BID 的 BIO101(20-羟基艾迪松)进行为期 21 周的双盲治疗。

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).

主要疗效终点是通过膝关节伸展测量的肌肉力量,重要的次要结果包括6分钟步行距离和其他性能测试、正常至瘦体重的肌肉力量、阑尾瘦体重和脂肪量、生物标志物和各种患者报告结果(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正准备申请一项研究性新药(IND),以便在未来几周内在美国启动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.

经监管部门批准,OBA 2期临床研究预计将于2024年中期开始,首批患者预计将在2024年下半年接受治疗。

First results of the safety and efficacy of BIO101 (20-hydroxyecdysone) drug candidate are expected to be available in 2025.

BIO101(20-羟基改松)候选药物的安全性和有效性的初步结果预计将于2025年公布。

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About BIOPHYTIS

关于 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是一家临床阶段的生物技术公司,专门开发年龄相关疾病的候选药物。BIO101(20-羟基坏死松)是我们的主要候选药物,是一种正在开发的小分子,用于肌肉疾病(肌肉减少症,3期就绪和杜氏肌肉萎缩症)、呼吸系统(Covid-19阶段2-3期已完成)和代谢性疾病(肥胖,第二阶段即将开始)。该公司总部位于法国巴黎和马萨诸塞州剑桥。该公司的普通股在泛欧交易所Growth上市(股票代码:ALBPS-ISIN:FR0012816825),ADS(美国存托股)在场外交易市场上市(股票代码:BPTSY——ISIN:US09076G4010)。欲了解更多信息,请访问

Forward-looking statements

前瞻性陈述

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.

本新闻稿包含前瞻性陈述。前瞻性陈述包括所有非历史事实的陈述。在某些情况下,你可以使用诸如 “展望”、“相信”、“预期”、“潜力”、“继续”、“可能”、“应该”、“可能”、“寻求”、“预测”、“打算”、“趋势”、“计划”、“估计”、“预期” 等词语或这些词语的负面版本或其他类似词语来识别这些前瞻性陈述。此类前瞻性陈述基于Biophytis认为合理的假设。但是,无法保证此类前瞻性陈述中包含的陈述会得到证实,这些陈述会受到各种风险和不确定性的影响。本新闻稿中包含的前瞻性陈述也受到Biophytis尚未知悉或Biophytis目前未被视为材料的风险的影响。因此,有或将来会有一些重要因素可能导致实际结果或结果与这些陈述中所示的结果或结果存在重大差异。另请参阅公司2023年财务报告中的 “公司将面临的风险和不确定性” 部分,该部分可在BIOPHYTIS网站上查阅(),20-F表格的 “风险因素” 部分以及向美国证券交易委员会(美国证券交易委员会)提交的其他表格。除非法律要求,否则我们没有义务公开更新或审查任何前瞻性陈述,无论是由于新信息、未来发展还是其他原因。

Biophytis contacts

生物体炎接触者

Investor relations

投资者关系

Nicolas Fellmann, CFO
Investors@biophytis.com

尼古拉斯·费尔曼,首席财务官
Investors@biophytis.com

Media

媒体

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

安托万·丹利:antoine.denry@taddeo.fr-+33 6 18 07 83 27
尼扎尔·贝拉达: nizar.berrada@taddeo.fr -+33 6 38 31 90 50

SOURCE: Biophytis

来源:Biophytis


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