RICHMOND, Calif.--(BUSINESS WIRE)--BioAge Labs, Inc., (“BioAge”), a clinical-stage biotechnology company developing therapeutics that target the molecular causes of aging to extend healthy human lifespan, today announced plans to initiate a Phase 2 trial of its oral apelin receptor agonist BGE-105 (azelaprag) co-administered with the GLP-1/GIP receptor agonist tirzepatide for treatment of obesity.

加利福尼亚州里士满-（商业线）-BioAge Labs，Inc.，（“BioAge”），一家临床阶段生物技术公司，开发针对衰老的分子原因的治疗药物，延长健康的人类寿命，今天宣布计划启动与其口服apelin受体激动剂BGE-105（azelapag）共同施用GLP-1/GIP受体激动剂tirzepatide治疗肥胖症的2期临床试验。

BioAge plans to initiate the trial in mid-2024..

BioAge计划在2024年中期启动试验。。

Chorus (link), an operationally independent clinical development organization within Eli Lilly and Company (“Lilly”) dedicated to working with biotechs to develop their assets from candidate through clinical proof of concept, will advise and assist BioAge on all aspects of the Phase 2 trial design and execution, under the terms of an agreement signed by both companies.

Chorus（link）是礼来公司（Eli Lilly and Company）（“Lilly”）内部的一家运营独立的临床开发组织，致力于与生物技术公司合作，通过临床概念验证从候选人开发资产，将根据两家公司签署的协议条款，就阶段2试验设计和执行。

As part of the collaboration, Lilly will also provide BioAge with tirzepatide..

作为合作的一部分，礼来公司还将提供tirzepatide的生物制剂。。

“We are thrilled to work directly with the clinical development experts at Chorus and benefit from Lilly’s expertise in obesity drug development,” said Kristen Fortney, PhD, CEO and co-founder of BioAge. “Our Phase 2 trial is designed to assess whether azelaprag can substantially increase the weight loss achieved with drugs of the incretin class.

BioAge首席执行官兼联合创始人克里斯汀·福特尼（Kristen Fortney）博士说：“我们很高兴能直接与Chorus的临床开发专家合作，并从礼来公司的肥胖药物开发专业知识中受益。“我们的2期临床试验旨在评估氮杂拉格是否可以显着增加肠降血糖素类药物的体重减轻。

This combination could enhance the performance of both injectable and oral incretin drugs. The oral route of administration of azelaprag makes it particularly exciting as a combination partner for next-generation oral incretins currently in development. As an additional benefit, azelaprag may help promote healthier weight loss.

这种组合可以增强注射和口服肠降血糖素药物的性能。azelapag的口服给药途径使其作为目前正在开发的下一代口服肠促胰岛素的组合伴侣特别令人兴奋。作为额外的好处，azelaprag可能有助于促进更健康的减肥。

Treating obesity has the potential to prevent or delay multiple diseases of aging and increase healthspan for a large segment of the population.”.

治疗肥胖有可能预防或延缓多种衰老疾病，并增加大部分人群的健康状况“。

The primary endpoint of the Phase 2 trial will be total weight loss, with related secondary endpoints to characterize additional potential benefits of the mechanism. BioAge will also collect aging-related biomarkers from the participants.

第二阶段试验的主要终点是总体重减轻，相关的次要终点是描述该机制的其他潜在益处。BioAge还将从参与者那里收集与衰老相关的生物标志物。

In preclinical studies, co-administration of azelaprag and tirzepatide to diet-induced obese mice increased total weight loss achieved on tirzepatide alone, normalized body composition to levels observed in lean controls, and decreased fed glucose levels without an appreciable decrease in calorie intake..

在临床前研究中，将azelapag和tirzepatide共同给予饮食诱导的肥胖小鼠可增加单独使用tirzepatide所达到的总体重减轻，将身体成分标准化至瘦对照组中观察到的水平，并降低进食葡萄糖水平而不会显着降低卡路里摄入量。。

Azelaprag mimics the activity of apelin, an “exerkine” peptide that is released in response to exercise. Apelin acts on skeletal muscle, heart, and central nervous system to regulate metabolism and promote muscle regeneration. Apelin signaling has demonstrated multiple benefits in energy metabolism in mouse models, including increased insulin sensitivity and reduction in fat mass..

Azelaprag模仿apelin的活性，apelin是一种响应运动而释放的“exerkine”肽。Apelin作用于骨骼肌，心脏和中枢神经系统，以调节新陈代谢并促进肌肉再生。Apelin信号传导已证明在小鼠模型的能量代谢中具有多种益处，包括增加胰岛素敏感性和减少脂肪量。。

In December 2022, BioAge announced positive topline results from a Phase 1b clinical trial showing that azelaprag treatment resulted in statistically significant prevention of muscle atrophy and maintenance of muscle protein synthesis in healthy volunteers aged 65 or older after 10 days of strict bed rest (link).

2022年12月，BioAge公布了1b期临床试验的阳性结果，显示在严格卧床休息10天后，azelapag治疗在65岁或以上的健康志愿者中导致肌肉萎缩和维持肌肉蛋白质合成的统计学显着预防链接）。

Azelaprag was well tolerated in this study and at all doses tested to date in 227 subjects, with a safety profile consistent with the findings of prior phase 1 trials conducted by Amgen..

Azelaprag在本研究中耐受性良好，迄今为止在227名受试者中测试的所有剂量，其安全性与Amgen进行的先前1期试验的结果一致。。

“Lilly is committed to enabling the biotech ecosystem by catalyzing breakthrough science,” said Nisha Nanda, Ph.D., Group VP of External Innovation at Lilly. “We are creating access to a suite of capabilities aimed at removing barriers to innovation such as our ‘one stop shop’ candidate to clinical Proof of Concept development unit Chorus.

礼来外部创新集团副总裁Nisha Nanda博士说：“礼来致力于通过催化突破性科学来实现生物技术生态系统。”。“我们正在创建一套旨在消除创新障碍的功能，例如我们的'一站式商店'候选人参加临床概念验证开发单元合唱团。

We are excited about the opportunity to collaborate with BioAge to share Lilly’s expertise in incretins, and utilize our Chorus clinical development engine to continue to advance the science to treat cardiometabolic diseases, like obesity.”.

我们很高兴有机会与BioAge合作分享礼来公司在肠促胰岛素方面的专业知识，并利用我们的Chorus临床开发引擎继续推进科学治疗心脏代谢疾病，如肥胖症“。

Chorus uses an internal staff of experienced drug developers and a network of external vendors to design and implement chemistry, manufacturing and control processes, preclinical toxicology and biology, and Phase I/II clinical trials, and deliver a ‘pharma-quality’ data package to maximize value inflection, in a rapid and highly capital-efficient manner..

Chorus使用经验丰富的药物开发商的内部人员和外部供应商网络来设计和实施化学，制造和控制过程，临床前毒理学和生物学以及I/II期临床试验，并提供“制药质量”数据包以最大限度地提高价值，以快速和高资本效率的方式。。

About BioAge Labs, Inc.

关于BioAge Labs，Inc。

BioAge is a clinical-stage biotechnology company developing a pipeline of treatments to extend healthy lifespan by targeting the molecular causes of aging. The company uses its discovery platform, which combines quantitative analysis of proprietary longitudinal human samples with detailed health records to map out the key molecular pathways that impact healthy human aging.

BioAge是一家临床阶段的生物技术公司，通过针对衰老的分子原因开发一系列治疗方法来延长健康寿命。该公司使用其发现平台，该平台将专有纵向人体样本的定量分析与详细的健康记录相结合，以绘制出影响健康人类衰老的关键分子途径。

By targeting the mechanisms of aging with a large and mechanistically diverse portfolio of drugs, BioAge is unlocking opportunities to treat or even prevent age-related disease in entirely new ways. BioAge's growing portfolio includes multiple assets targeting muscle, immune, and brain aging. To date, BioAge has raised $127M from Andreessen Horowitz, Kaiser Foundation Hospitals, and others..

通过以大量机械多样的药物组合为目标的老龄化机制，BioAge正在释放机会，以全新的方式治疗甚至预防与年龄有关的疾病。BioAge不断增长的产品组合包括针对肌肉，免疫和大脑老化的多种资产。迄今为止，BioAge已经从Andreessen Horowitz，Kaiser Foundation Hospitals等公司筹集了1.27亿美元。。