NEW YORK--(BUSINESS WIRE)--Metsera, Inc., a clinical-stage biopharmaceutical company accelerating the next generation of medicines for obesity and metabolic diseases, today announced positive topline results from the Phase 1 clinical trial of MET-097, an ultra long-acting injectable, fully-biased GLP-1 receptor agonist.

纽约--（商业新闻短讯）--Metsera，Inc.，一家临床阶段的生物制药公司，正在加速下一代肥胖和代谢疾病药物的开发，今天宣布了MET-097（一种超长效可注射，完全偏向的GLP-1受体激动剂）的1期临床试验的阳性结果。

In this study, MET-097 achieved significant and durable weight loss, supporting a potential once-monthly dosing regimen..

在这项研究中，MET-097实现了显着且持久的体重减轻，支持了潜在的每月一次的给药方案。。

“We are excited about these positive results, which position MET-097 as an ultra-long acting, potent, yet well tolerated GLP-1 drug candidate,” said Steve Marso, M.D., chief medical officer of Metsera. “We are encouraged by both the safety profile and initial efficacy, in which MET-097 achieved weight loss matching, or potentially exceeding, currently available and investigational next-generation GLP-1 and GLP-1 combination drugs.

Metsera首席医疗官Steve Marso医学博士说：“我们对这些积极的结果感到兴奋，MET-097被认为是一种超长效，有效但耐受性良好的GLP-1候选药物。”。“我们对MET-097的安全性和初始疗效感到鼓舞，其中MET-097达到了与目前可用的和正在研究的下一代GLP-1和GLP-1联合药物相匹配或可能超过的减肥效果。

Importantly, these data suggest the possibility for no titration and once monthly dosing, which may result in a more convenient, more scalable, and better tolerated way to administer GLP-1 medicines.”.

重要的是，这些数据表明不进行滴定和每月一次给药的可能性，这可能会导致一种更方便，更具可扩展性和更好耐受性的GLP-1药物给药方式。”。

The randomized, placebo-controlled, double-blind Phase 1 trial was designed to evaluate the tolerability, pharmacokinetics, pharmacodynamics and efficacy of subcutaneous MET-097 in 125 healthy, non-diabetic, overweight or obese adult participants. MET-097 was evaluated at single doses from 0.16 mg to 1.6 mg and weekly doses from 0.2 mg to 1.2 mg, given five times without titration..

这项随机，安慰剂对照，双盲1期试验旨在评估125名健康，非糖尿病，超重或肥胖成年参与者皮下MET-097的耐受性，药代动力学，药效学和疗效。MET-097的单次剂量为0.16 mg至1.6 mg，每周剂量为0.2 mg至1.2 mg，无需滴定五次。。

Topline results from the Phase 1 trial include:

第一阶段试验的主要结果包括：

Observed dose-linear pharmacokinetics with a half-life of 380 hours, consistent from subject-to-subject, based on the ultra-long clearance conferred by HALO™, Metsera’s proprietary, novel peptide lipidation platform technology. This translates to a 2-3 fold longer half-life than currently available and investigational nutrient-stimulated hormone (NuSH) products..

基于HALO™超长清除率（Metsera专有的新型肽脂化平台技术），观察到半衰期为380小时的剂量线性药代动力学，受试者与受试者一致。这意味着半衰期比目前可用的和研究性营养刺激激素（NuSH）产品长2-3倍。。

Gastrointestinal adverse events were dose-related, mostly mild, and transient. Occurrence of these events was consistent with marketed and clinical-stage NuSH compounds. No severe treatment-related adverse events were observed, and there were no treatment-related study drug discontinuations.

胃肠道不良事件与剂量有关，大多是轻度和短暂的。。没有观察到严重的治疗相关不良事件，也没有治疗相关的研究药物停药。

Change in body weight from baseline was dose-dependent, and at 1.2 mg was 7.5% at day 36 (one week after the final dose), consistent with or better than marketed and clinical-stage GLP-1 / GIP compounds.

体重从基线的变化是剂量依赖性的，在第36天（最终剂量后一周），1.2 mg时为7.5%，与市售和临床阶段的GLP-1/GIP化合物一致或更好。

Cumulative weight loss at the 1.2mg dose was 8.1% at day 57, four weeks after the final dose, suggesting durable pharmacodynamic effect consistent with the observed 380 hour half-life.

在最终剂量后四周，第57天，1.2mg剂量的累积体重减轻为8.1%，表明持久的药效学效应与观察到的380小时半衰期一致。

“The Phase 1 data show that our proprietary HALO™ technology platform clearly confers ultra-long product half-life in people, validating the science underlying the Metsera discovery strategy. Based on these strong results, we believe we can produce a series of NuSH analogs with half-lives between 2-3-fold longer than the current marketed and investigational peptide NuSH analogs, and on par with antibody conjugated NuSH analogs,” said Brian Hubbard, Ph.D., chief scientific officer of Metsera..

Metsera首席科学官Brian Hubbard博士说：“第一阶段的数据表明，我们专有的HALO™技术平台明显赋予人体超长的产品半衰期，验证了Metsera发现策略的科学基础。基于这些强有力的结果，我们相信我们可以生产出一系列NuSH类似物，其半衰期比目前上市和研究的肽NuSH类似物长2-3倍，与抗体偶联的NuSH类似物相当。”。。

Metsera plans to initiate a Phase 2b trial of MET-097 in Q4 2024, with data anticipated in the first half of 2025.

梅瑟拉计划在2024年第四季度启动MET-097的2b期试验，预计数据将在2025年上半年发布。

About Metsera

关于梅瑟拉

Metsera is a clinical-stage biopharmaceutical company accelerating the next generation of medicines for obesity and metabolic diseases. Metsera is advancing a broad portfolio of oral and injectable incretin, non-incretin and combination therapies with potential best-in-class profiles to address multiple therapeutic targets and meet the future needs of a rapidly evolving weight loss treatment landscape.

Metsera是一家临床阶段的生物制药公司，加速下一代肥胖和代谢疾病药物的开发。Metsera正在推进口服和注射肠降血糖素，非肠降血糖素和联合治疗的广泛组合，具有潜在的同类最佳概况，以解决多个治疗目标，并满足快速发展的减肥治疗领域的未来需求。

Founded in 2022 by Population Health Partners and ARCH Venture Partners, Metsera has raised $322 million in financing from leading healthcare investors and is based in New York City. For more information, please visit us at www.metsera.com and follow us on LinkedIn..

Metsera由人口健康合作伙伴（Population Health Partners）和ARCH Venture Partners于2022年成立，从领先的医疗保健投资者那里筹集了3.22亿美元的资金，总部位于纽约市。欲了解更多信息，请访问www.metsera.com并在LinkedIn上关注我们。。