Biophytis启动BIO101（20-羟基蜕皮激素）治疗肥胖的OBA 2期临床研究-动脉网

Biophytis launches OBA phase 2 clinical study in obesity with BIO101 (20-hydroxyecdysone)

BioSpace 等信源发布 2024-04-08 12:43

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Promising preclinical results obtained in obesity support the OBA Phase 2 clinical study expected to start mid-2024

肥胖方面取得的有希望的临床前结果支持了预计将于2024年年中开始的OBA 2期临床研究

PARIS, FRANCE AND CAMBRIDGE, MA / ACCESSWIRE / April 8, 2024 / Biophytis SA (Nasdaq:BPTS)(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 that it is launching a new clinical development program named OBA, with BIO101 (20-hydroxyecdysone) as a potential treatment for obesity in combination with GLP-1 receptor agonists..

法国巴黎和剑桥，马萨诸塞州/ACCESSWIRE/2024年4月8日/Biophytis SA（纳斯达克：BPTS）（泛欧增长巴黎：ALBPS），（“Biophytis”或“公司”）是一家临床阶段的生物技术公司，专门从事与年龄有关的疾病的治疗药物的开发，今天宣布，它正在启动一项名为OBA的新临床开发计划，其中BIO101（20-羟基蜕皮激素）与GLP-1受体激动剂联合作为肥胖的潜在治疗药物。。

Muscle loss due to obesity treatment: no therapy available today

肥胖治疗导致的肌肉损失：目前尚无治疗方法

Obesity treatment can lead to loss of muscle mass and function, notably as a consequence of dieting when combined with the recently introduced GLP-1 receptor agonists. Glucagon-like peptide-1 receptor agonist (GLP-1 RA) drugs are very effective drugs that lead to significant weight loss. Up to 40% of the total weight loss comes from muscle, which is a problem as muscle tissue's role is central in controlling metabolism, on top of its motor function..

肥胖治疗可能导致肌肉质量和功能的丧失，特别是与最近引入的GLP-1受体激动剂结合节食的结果。胰高血糖素样肽-1受体激动剂（GLP-1 RA）药物是非常有效的药物，可导致显着的体重减轻。高达40%的总体重减轻来自肌肉，这是一个问题，因为除了运动功能外，肌肉组织在控制新陈代谢方面的作用至关重要。。

More than 15 million adults in the US will be treated with an anti-obesity medication by 2030, representing 13% penetration into the US adult population. With an estimated market size of $6 billion in 2023 and an estimated average annual growth rate expected around 42%, the addressable market for the treatment of obesity is set to reach $100 billion by 2030 (source: Goldman Sachs Research)..

到2030年，美国将有1500多万成年人接受抗肥胖药物治疗，占美国成年人口的13%。2023年预计市场规模为60亿美元，预计年平均增长率约为42%，到2030年，肥胖症治疗的目标市场将达到1000亿美元（来源：高盛研究公司）。。

Promising results already obtained in obesity

肥胖症已经取得了有希望的结果

BIO101 (20-hydroxyecdysone) is the first oral daily MAS receptor activator and has demonstrated metabolic effects on muscle and fat tissues in preclinical studies in obesity. These benefical effects of BIO101 (20-hydroxyecdysone) may translate into improved mobility and muscle strength in obese sarcopenic patients, as suggested in the SARA-INT phase 2 study.

BIO101（20-羟基蜕皮激素）是第一种口服每日MAS受体激活剂，在肥胖症的临床前研究中已证明对肌肉和脂肪组织具有代谢作用。正如SARA-INT 2期研究所建议的那样，BIO101（20-羟基蜕皮激素）的这些有益作用可能会改善肥胖肌肉减少症患者的活动能力和肌肉力量。

Furthermore, the 20-hydroxyecdysone molecule was already tested in obese patients during hypocaloric dieting in the Quinolia study, showing promising effects on muscle strength and fat mass loss. BIO101's (20-hydroxyecdysone) potential in the treatment of obesity in combination with GLP-1RAs to counteract the undesirable effects on muscle wasting associated with drastic weight-loss was highlighted in Nature Biotechnology ('After obesity drugs' success, companies rush to preserve skeletal muscle') on March 05, 2024..

此外，在奎奴利亚研究中，肥胖患者在低热量饮食期间已经测试了20-羟基蜕皮激素分子，显示出对肌肉力量和脂肪量减少的有希望的作用。2024年3月5日，Nature Biotechnology（肥胖药物成功后，公司争相保护骨骼肌）强调了BIO101（20-羟基蜕皮激素）与GLP-1RAs联合治疗肥胖的潜力，以抵消与剧烈减肥相关的肌肉消瘦的不良影响。。

Stanislas Veillet, CEO of Biophytis, stated: '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 with GLP-1 RAs. Our drug candidate,subject to regulatory approvals, could contribute to meeting crucial medical challenges, while positioning Biophytis in a large market with incredibly high growth potential.

Biophytis首席执行官Stanislas Veillet表示：“我们认为BIO101（20-羟基蜕皮激素）有可能成为接受GLP-1 RAs治疗的肥胖患者保留肌肉功能的首选分子。我们的候选药物在获得监管部门批准的情况下，可能有助于应对关键的医学挑战，同时将生物植物定位于具有极高增长潜力的大型市场。

We believe that our leadership in developing drugs for muscular diseases and promising results obtained in obesity will be a strong accelerator of the OBA clinical plan.'.

我们相信，我们在开发肌肉疾病药物方面的领导地位以及在肥胖方面取得的有希望的结果将成为OBA临床计划的有力加速器。”。

An accelerated clinical development with results expected in 2025

加速临床开发，预计2025年取得成果

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. BIO101 (20-hydroxyecdysone) will be evaluated in obese patients treated with GLP-1 RAs, and following hypocaloric dieting. We expect the first results of the efficacy of our drug candidate to be available in 2025.

经监管部门批准，OBA 2期临床研究预计将于2024年年中开始，首批患者预计将在2024年下半年接受治疗。BIO101（20-羟基蜕皮激素）将在用GLP-1 RAs治疗的肥胖患者和低热量饮食后进行评估。我们预计2025年将获得我们候选药物疗效的初步结果。

Further information on the OBA program and the clinical study is expected to be provided through the coming weeks..

预计未来几周将提供有关OBA计划和临床研究的更多信息。。

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About BIOPHYTIS

关于生物植物

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).

Biophytis SA是一家临床阶段生物技术公司，专门开发与年龄相关疾病的候选药物。我们的主要候选药物BIO101（20-羟基蜕皮激素）是一种正在开发的小分子，用于肌肉（肌肉减少症，3期就绪和杜兴氏肌营养不良症），呼吸（Covid-19 2-3期完成）和代谢疾病（肥胖，2期开始）。

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 www.biophytis.com.

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Euronext Growth上市（股票代码：ALBPS-ISIN：FR0012816825），ADSs（美国存托股）在纳斯达克资本市场上市（股票代码：BPTS-ISIN：US09076G1040）。有关更多信息，请访问www.biophytis.com。

Disclaimer

免责声明

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 thesewords or other comparable words.

本新闻稿包含前瞻性声明。前瞻性陈述包括所有非历史事实的陈述。在某些情况下，你可以通过使用诸如“展望”、“相信”、“期望”、“潜力”、“继续”、“可能”、“意志”、“应该”、“可能”、“寻求”、“预测”、“打算”、“趋势”、“计划”、“估计”、“预期”或这些词或其他类似词的负面版本来识别这些前瞻性陈述。

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.

此类前瞻性陈述基于Biophytis认为合理的假设。然而，不能保证此类前瞻性声明中包含的声明会得到验证，因为这些声明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声明也受到生物植物尚不知道或目前生物植物尚未考虑的风险的影响。

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 FinancialReport available on BIOPHYTIS website (www.biophytis.com) 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).

因此，有或将有重要因素可能导致实际结果或结果与这些声明中所示的结果或结果存在重大差异。另请参阅BIOPHYTIS网站（www.BIOPHYTIS.com）上提供的公司2023年财务报告中的“公司将面临的风险和不确定性”部分，以及表格20-F的“风险因素”部分以及提交给SEC（美国证券交易委员会）的其他表格。

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..

我们没有义务公开更新或审查任何前瞻性声明，无论是由于新信息、未来发展还是其他原因，除非法律要求。。

Biophytis contacts

生物植物接触

Investor relations

投资者关系

Nicolas Fellmann, CFO

首席财务官Nicolas Fellmann

Investors@biophytis.com

Media

媒体

Antoine Denry: antoine.denry@taddeo.fr - +33 6 18 07 83 27

Antoine Denry：antoine.denry@taddeo.fr- +33 6 18 07 83 27