Monday, Biophytis SA (NASDAQ:BPTS) announced the launch of a new clinical development program named OBA, with BIO101 (20-hydroxyecdysone) as a potential treatment for obesity combined with GLP-1 receptor agonists.
The OBA Phase 2 clinical study is expected to start in mid-2024, upon regulatory approvals, with the 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.
With accelerated clinical development, the first efficacy results are expected in 2025.
The company says BIO101 (20-hydroxyecdysone) is the first oral daily MAS receptor activator and has demonstrated metabolic effects on muscle and fat tissues in preclinical obesity studies.
These beneficial 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.
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.
In its 2023 earnings release, the company shared the final results of the Phase 2/3 COVA trial.
The study met its primary objective, with a 44% (p=0.043) reduction in the risk of respiratory failure or early death in patients hospitalized with severe COVID-19.
In addition, BIO101 (20-hydroxyecdysone) showed an encouraging safety profile, with a lower proportion of patients experiencing adverse events than placebo (57% vs. 64%).
The company is implementing regulatory procedures to assess market access conditions based on the COVA study results and preparation for the design of a second confirmatory phase 3 trial.
Biophytis is also establishing industrial partnerships with the Seqens and Skyepharma groups to produce the BIO101 (20-hydroxyecdysone) drug candidate commercially.
Price Action: BPTS shares are up 22.30% at $0.39 on the last check Tuesday.
Photo via Shutterstock
週一，Biophytis SA（納斯達克股票代碼：BPTS）宣佈啓動一項名爲OBA的新臨床開發計劃，該項目將 BIO101（20-羥基改性酮）與GLP-1 受體激動劑聯合用作肥胖的潛在治療方法。
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。
將對接受 GLP-1 RA 治療和低熱量節食後的肥胖患者進行評估 BIO101（20-羥基ecdysone）。
隨着臨床開發的加速，預計將在2025年取得首批療效結果。
該公司表示，BIO101（20-羥基ecdysone）是第一種每日口服 MAS 受體激活劑，在臨床前肥胖研究中已顯示出對肌肉和脂肪組織的代謝作用。
正如SARA-INT 2期研究所表明的那樣，BIO101（20-羥基ecdysone）的這些有益作用可能會轉化爲肥胖肌肉減少症患者的活動能力和肌肉力量的改善。
此外，在Quinolia的研究中，在低熱量節食期間，已經在肥胖患者身上測試了20-羥基ecdysone分子，顯示出對肌肉力量和脂肪量減少的積極影響。
在2023年業績中，該公司分享了第2/3階段COVA試驗的最終結果。
該研究實現了其主要目標，重度 COVID-19 住院患者的呼吸衰竭或過早死亡風險降低了44％（p=0.043）。
此外，BIO101（20-羥基ecdysone）顯示出令人鼓舞的安全性，出現不良事件的患者比例低於安慰劑（57％對64％）。
該公司正在實施監管程序，根據COVA研究結果評估市場準入條件，併爲第二項確認性3期試驗的設計做準備。
Biophytis還與Seqens和Skyepharma集團建立了產業合作伙伴關係，以商業化生產 BIO101（20-羥基ecdysone）候選藥物。
價格走勢：在週二的最後一次支票中，BPTS股價上漲22.30％，至0.39美元。
照片來自 Shutterstock
