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)--Metsera, Inc., a clinical-stage biopharmaceutical company accelerating the next generation of medicines for obesity and metabolic diseases, today announced positive data from a 12-week Phase 2a clinical trial of MET-097i, its potential once-monthly, ultra-long acting, subcutaneously injectable, fully-biased, GLP-1 receptor agonist (RA)..

)--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-097i为期12周的2a期临床试验的积极数据，该试验具有每月一次的潜力，超长效，皮下注射，完全偏向的GLP-1受体激动剂（RA）。。

The randomized, double blind, placebo-controlled, Phase 2a trial enrolled 120 participants with obesity and overweight who did not have Type 2 diabetes. MET-097i was tested in five cohorts of 24 participants (20 active drug, 4 placebo). In four of these cohorts, participants were given 0.6mg, 0.8mg, 1.0mg, or 1.2mg, weekly, without titration, for 12 weeks.

这项随机、双盲、安慰剂对照的2a期临床试验招募了120名肥胖和超重且没有2型糖尿病的参与者。MET-097i在24名参与者的五个队列中进行了测试（20种活性药物，4种安慰剂）。在其中四个队列中，参与者每周给予0.6mg，0.8mg，1.0mg或1.2mg，无需滴定，持续12周。

Participants in the fifth cohort were also given weekly doses but this time with escalated doses of 0.4mg for 4 weeks, then 0.8mg for 4 weeks, then 1.2mg for 4 weeks. At week 13, all participants were given either a two- or four-fold step-up in dose, to assess the tolerability of switching to a pharmacologically matched, potential monthly dose..

第五组的参与者也每周服用一次剂量，但这次剂量增加为0.4mg，持续4周，然后是0.8mg，持续4周，然后是1.2mg，持续4周。在第13周，所有参与者的剂量都增加了两倍或四倍，以评估转换为药理学匹配的潜在月剂量的耐受性。。

Weight loss was dose-dependent, with substantial reductions in mean body weight of 11.3% (placebo-adjusted) and individual responses as high as ~20% in the 1.2mg dose cohort after 12 weekly doses. A weight loss plateau was not reached, suggesting additional weight loss potential with longer-term dosing.

体重减轻是剂量依赖性的，在12周剂量后，平均体重显着降低11.3%（安慰剂调整），并且在1.2mg剂量组中个体反应高达〜20%。没有达到减肥平台，这表明长期给药会产生额外的减肥潜力。

All cohorts achieved clinically meaningful and statistically significant weight loss after 12 weeks of dosing..

给药12周后，所有队列均实现了具有临床意义和统计学意义的体重减轻。。

MET-097i was generally well tolerated in all dose groups regardless of schedule. Gastrointestinal adverse events (AEs) were all mild or moderate and short-lived. Compelling tolerability was observed in the fifth cohort given titrated doses. In this cohort of 20 participants, only one case of mild, transient nausea and two cases of mild, transient vomiting were observed.

无论时间表如何，MET-097i在所有剂量组中均具有良好的耐受性。胃肠道不良事件（AE）均为轻度或中度且短暂。在给予滴定剂量的第五组中观察到令人信服的耐受性。在这20名参与者的队列中，仅观察到1例轻度短暂性恶心和2例轻度短暂性呕吐。

Mean body weight loss of 6.3% (placebo-adjusted) was observed in this dose-escalated cohort..

在这个剂量递增的队列中观察到平均体重减轻6.3%（安慰剂调整）。。

Pharmacological exposure accumulated approximately four-fold over the course of 12 weeks in the titration-free cohorts, driven by the 15-16 day half-life of MET-097i, reinforcing the potential for titration-free dosing. At week 13, step-up to a four-fold higher dose was well-tolerated in all cohorts, supporting the idea that monthly dosing is feasible with this unique, ultra-long acting, GLP-1RA.

在MET-097i的15-16天半衰期的驱动下，在无滴定队列中，药物暴露在12周的过程中累积了大约四倍，增强了无滴定给药的潜力。在第13周，所有队列都能很好地耐受增加到四倍的剂量，这支持了这种独特的，超长效的GLP-1RA每月给药是可行的想法。

The company plans to launch an additional study to confirm this finding across multiple monthly doses in early 2025..

该公司计划在2025年初进行一项额外的研究，以证实这一发现，每月多次服用。。

John Buse, M.D., Verne S. Caviness Distinguished Professor and Director of the UNC Diabetes Center at University of North Carolina School of Medicine, said, “Taken together, these data suggest that MET-097i has the potential to be a foundational therapy for people with obesity and overweight, by virtue of its effectiveness, compelling tolerability profile and flexible options for dosing, including titration-free weekly dosing and monthly dosing.”.

北卡罗莱纳大学医学院北卡罗莱纳大学糖尿病中心主任、著名教授、医学博士约翰·巴斯（JohnBuse）表示：“综上所述，这些数据表明，MET-097i凭借其有效性、令人信服的耐受性和灵活的给药选择，包括无滴定的每周给药和每月给药，有可能成为肥胖和超重人群的基础疗法。”。

“These data strengthen our view of MET-097i as the potential first ultra-long acting GLP-1RA,” added Steve Marso, M.D., Chief Medical Officer of Metsera. “The powerful reductions in weight affirm our earlier studies. We are also excited by the emerging tolerability and dosing profile of MET-097i, which may offer versatility and meaningful advantages for patients.”.

“这些数据强化了我们对MET-097i作为潜在的第一个超长效GLP-1RA的看法，”梅瑟拉首席医疗官Steve Marso医学博士补充道。“体重的大幅减轻证实了我们早期的研究。我们也对MET-097i的耐受性和剂量特征感到兴奋，这可能为患者提供多功能性和有意义的优势。”。

In parallel, Metsera’s Phase 2b trial of MET-097i in people with obesity or overweight has been fully enrolled with 239 trial participants. The company anticipates topline data from this trial in mid-2025. Additional trials exploring MET-097i in people with obesity, overweight, and Type 2 diabetes, including participants given monthly dosing, are expected in 2025.

与此同时，Metsera针对肥胖或超重人群的MET-097i 2b期试验已被239名试验参与者完全登记。该公司预计2025年年中将获得该试验的最终数据。预计2025年将有更多试验探索肥胖，超重和2型糖尿病患者的MET-097i，包括每月给药的参与者。

If these trials are successful, Metsera plans to initiate Phase 3 trials shortly thereafter..

如果这些试验成功，梅瑟拉计划在此后不久启动第三阶段试验。。

About MET-097i

关于MET-097i

MET-097i, Metsera’s most advanced product candidate, is a fully-biased, potential once-monthly, ultra-long acting, subcutaneously injectable GLP-1 receptor agonist. Positive 12-week results from a Phase 2a trial demonstrated substantial placebo-adjusted weight loss of up to 11.3% in the 1.2mg cohort at day 85 and was generally well tolerated across dose groups.

Metsera最先进的候选产品MET-097i是一种完全有偏见的潜在每月一次的超长效皮下注射GLP-1受体激动剂。2a期试验的阳性12周结果显示，在第85天，1.2mg队列中安慰剂调整后的体重减轻了11.3%，并且在各剂量组中通常耐受性良好。

MET-097i, incorporating Metsera’s HALO™ platform technology, demonstrated a preliminary half-life of 15-16 days, supporting the potential for once-monthly dosing and dosing regimens with or without titration. Future studies are planned to confirm its safety, tolerability, clinical efficacy and overall risk-benefit profile.

MET-097i结合了Metsera的HALO™平台技术，初步半衰期为15-16天，支持每月一次的给药和有或没有滴定的给药方案。未来的研究计划确认其安全性，耐受性，临床疗效和总体风险-收益概况。

MET-097i is currently in Phase 2b as a monotherapy, with additional plans to evaluate it in combination with Metsera’s ultra-long acting amylin analogue, MET-233i, and other ultra-long acting nutrient-stimulated hormone (NuSH) analog peptide injectables in future studies..

MET-097i目前作为单一疗法处于2b期，另外计划在未来的研究中与Metsera的超长效胰淀素类似物MET-233i和其他超长效营养刺激激素（NuSH）类似肽注射剂联合评估。。

About Metsera’s HALO™ peptide lipidation platform

关于Metsera的HALO™肽脂化平台

HALO™ is Metsera’s novel peptide lipidation platform technology that enables peptides to bind simultaneously to albumin and to a drug target, resulting in a half-life approaching that of albumin and exceeding that of other NuSH peptides by two-to-threefold. This ultra-long half-life enables four key advantages: titration-free dosing, monthly dosing, improved tolerability, and improved scalability..

HALO™是Metsera的新型肽脂化平台技术，可使肽同时与白蛋白和药物靶标结合，从而使半衰期接近白蛋白，超过其他NuSH肽的半衰期两到三倍。这种超长的半衰期具有四个关键优势：无滴定剂量，每月剂量，改善耐受性和改善可扩展性。。

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 over $500 million in financing from leading healthcare investors and is based in New York City..

Metsera由人口健康合作伙伴和ARCH Venture Partners于2022年成立，从领先的医疗保健投资者那里筹集了超过5亿美元的资金，总部位于纽约市。。