歌礼宣布其美国Ib期临床试验ASC30取得积极中期结果，ASC30是一种潜在的首创小分子GLP-1R激动剂皮下注射药物-动脉网

Ascletis Announces Positive Interim Results from Its U.S. Phase Ib Trial with ASC30, a Potentially First-in-Class Subcutaneous Injection Small Molecule GLP-1R Agonist

CISION 等信源发布 2025-03-31 19:00

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可切换为仅中文

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-Ultra-long-

超长

acting subcutaneous (SQ)

皮下注射（SQ）

injection

注入

formulation of small molecule ASC30 demonstrated a 36-day half-life in patients with obesity, supporting once monthly or less frequent administration.

小分子ASC30的制剂在肥胖患者中显示出36天的半衰期，支持每月一次或更少频率的给药。

-As previously disclosed, oral tablet formulation of small molecule ASC30 demonstrated potentially best-in-class 6.3% weight loss in patients with obesity after a four-week tr

-正如之前披露的，小分子ASC30的口服片剂配方在肥胖患者中四周治疗后显示出潜在的最佳6.3%体重减轻。

eatment.

治疗。

HONG KONG

香港

，

March 31, 2025

2025年3月31日

/PRNewswire/ -- Ascletis Pharma Inc. (HKEX:1672, 'Ascletis') today announces positive interim results from its randomized, double-blind, placebo-controlled Phase Ib single subcutaneous (SQ) injection study (

/PRNewswire/ -- 歌礼制药有限公司（HKEX:1672，'歌礼'）今日宣布其随机、双盲、安慰剂对照的Ib期单次皮下注射（SQ）研究的中期结果积极。

NCT06679959

), conducted in the U.S., of small molecule ASC30 with three ultra-long-acting SQ injection formulations in patients with obesity (body mass index (BMI): 30-40 kg/m

在美国进行的小分子ASC30与三种超长效皮下注射制剂在肥胖患者（体重指数（BMI）：30-40公斤/平方米）中的研究

）。

The Phase Ib study investigated the half-life of three ultra-long-acting SQ injection formulations of ASC30 (100 mg, single injection), a small molecule

第一阶段b研究调查了三种超长效ASC30（100毫克，单次注射）的小分子皮下注射制剂的半衰期。

GLP-1

receptor (GLP-1R) agonist, developed from Ascletis' ultra-long-acting platform (ULAP). In each cohort, eight patients received one formulation of ASC30 SQ injection and two patients were on volume-matched placebo.

受体（GLP-1R）激动剂，源自歌礼超长效平台（ULAP）。每个队列中，八名患者接受一种ASC30皮下注射制剂，两名患者接受等体积安慰剂。

One of the evaluated three formulations demonstrated a 36-day half-life in patients with obesity after a single SQ injection, supporting once monthly or less frequent administration. In addition, this formulation is a sterile solution for SQ injection and stable around neutral pH, allowing for potential co-formulation and co-administration with other drugs or drug candidates.

其中一种经过评估的三种配方在肥胖患者中单次皮下注射后显示出36天的半衰期，支持每月一次或更少频率的给药。此外，该配方是一种用于皮下注射的无菌溶液，在接近中性的pH值下稳定，允许与其他药物或候选药物潜在地共同配方和共同给药。

This formulation of small molecule ASC30 SQ injection is advancing into further clinical trials to evaluate clinical efficacy at doses above 100 mg..

这种小分子ASC30皮下注射制剂正在进入进一步的临床试验，以评估高于100毫克剂量下的临床疗效。

The other two formulations, which have different chemical and physical properties from the formulation mentioned above, also demonstrated ultra-long-acting potential in patients with obesity.

另外两种配方，其化学和物理特性与上述提到的配方不同，但在肥胖患者中也展示了超长效的潜力。

As previously disclosed, the oral tablet formulation of small molecule ASC30 demonstrated potentially best-in-class 6.3% weight loss in patients with obesity after a four-week treatment (

正如之前披露的，小分子ASC30的口服片剂配方在肥胖患者接受为期四周的治疗后，显示出潜在的最佳减重效果，体重减轻了6.3%。

Press Release

新闻稿

）。

ASC30 SQ injection was generally well tolerated, demonstrating a favorable safety profile in the Phase Ib study. No serious adverse events (SAEs) were reported. There were no Grade 3 or higher adverse events (AEs) observed. The majority of gastrointestinal (GI)-related AEs were mild (Grade 1). There were no elevations of liver enzymes including alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin (TBL).

ASC30 SQ注射在Ib期研究中总体耐受性良好，显示出良好的安全性。未报告严重不良事件（SAEs）。未观察到3级或更高级别的不良事件（AEs）。大多数胃肠道（GI）相关不良事件为轻度（1级）。未发现肝酶升高，包括丙氨酸氨基转移酶（ALT）、天门冬氨酸氨基转移酶（AST）和总胆红素（TBL）。

There were no abnormal findings in laboratory tests, vital signs, ECGs (electrocardiograms, including QTc intervals), and physical exams. Most injection site reactions of ASC30 were mild. There were no Grade 3 or higher injection site reactions..

实验室检查、生命体征、心电图（包括QTc间期）和体格检查均未发现异常。ASC30的大多数注射部位反应较轻，未出现3级或更高级别的注射部位反应。

ASC30 was discovered and developed in-house at Ascletis as a first and only investigational small molecule GLP-1R biased agonist designed to be dosed once daily orally and once monthly or less frequent subcutaneously for the treatment of obesity.

ASC30 是歌礼制药自主研发的首个也是唯一一个在研小分子 GLP-1R 偏向激动剂，设计为每日一次口服给药，或每月一次或更少频次皮下注射，用于治疗肥胖症。

'We are excited about the 36-day half-life of ASC30 SQ injection from our Phase Ib study of potentially first-in-class once-monthly injectable small molecule GLP-1R agonist to treat patients with obesity,' said

“我们对ASC30 SQ注射剂在Ib期研究中显示出的36天半衰期感到兴奋，这种潜在的首创每月一次的小分子GLP-1R激动剂注射剂用于治疗肥胖患者，”

Jinzi Jason Wu

金子杰森·吴

, Ph.D., Founder, Chairman and CEO of Ascletis. 'Once monthly or less frequent injection is critical in a market as large as obesity since it could save 75% or more devices and cartridges that are needed for once-weekly injectable medicines, in addition to enhanced compliance and convenience. Furthermore, ASC30 has the potential to offer both once-daily oral and once-monthly subcutaneous injection dosing options for patients, if approved.'.

博士，Ascletis创始人、董事长兼首席执行官。“在肥胖症这样庞大的市场中，每月一次或更低频率的注射至关重要，因为它可以节省75%或更多的设备和注射器，这些是每周一次注射药物所需要的，同时还能提高患者的依从性和便利性。此外，如果获得批准，ASC30有可能为患者提供每日一次口服和每月一次皮下注射两种剂量选择。”

About ASC30

关于ASC30

ASC30 is an investigational GLP-1R biased small molecule agonist and has unique and differentiated properties that enable the same small molecule for both oral tablet and subcutaneous injection administrations. ASC30 is a new chemical entity (NCE), with U.S. and global compound patent protection until 2044. .

ASC30 是一种在研的 GLP-1R 偏向性小分子激动剂，具有独特且差异化的特点，可使同一小分子适用于口服片剂和皮下注射两种给药方式。ASC30 是一种新化学实体 (NCE)，在美国和全球范围内享有化合物专利保护直至 2044 年。

About Ascletis Pharma Inc.

关于歌礼制药有限公司

Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK), covering the entire value chain from discovery and development to GMP manufacturing. Led by a management team with deep expertise and a proven track record, Ascletis is focused on metabolic diseases by addressing unmet medical needs from a global perspective.

歌礼是一家在香港证券交易所上市（1672.HK）的创新研发驱动型生物科技公司，覆盖从发现、开发到GMP生产的完整价值链。由具有深厚专业知识和成功经验的管理团队领导，歌礼专注于通过全球视角解决未被满足的医疗需求，致力于代谢性疾病的研究。

Ascletis has multiple clinical stage drug candidates in its metabolic disease pipeline..

歌礼在代谢疾病领域拥有多个临床阶段的候选药物。

For more information, please visit

欲了解更多信息，请访问

www.ascletis.com

。

Contact：

联系：

Peter Vozzo

彼得·沃佐

ICR Healthcare