安济盛宣布AGA2118治疗骨质疏松症临床II期试验完成首例患者给药

安济盛生物

2024/11/04

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成骨不全骨质疏松症 DKK1 安济盛生物医药技术（广州）有限公司 SOST

二期临床试验在美国和欧盟开展

美国加州WOODLAND HILLS和中国广东广州- 2024年11月4日：安济盛生物，一家专注于骨骼、关节和肌肉重症疾病领域的创新药物研发公司，今日宣布完成AGA2118，一种同时靶向硬骨抑素和DKK1的双特异性抗体，在治疗骨质疏松症临床II期试验（ARTEMIS）中的首例患者给药。

安济盛首席医学官Willard H. Dere博士表示：“在针对绝经后骨质疏松症患者的临床II期试验中完成首例患者给药是AGA2118开发过程中的一个重要里程碑。这项II期研究是在公司最近于ASBMR年会上展示的AGA2118首次临床I期试验数据的基础上进行的。临床I期试验数据显示AGA2118能快速并显著增加骨密度。我们期待进一步推进这项差异化的新型骨质疏松症治疗方案的临床开发。”

本项临床II期试验是一项随机、双盲、安慰剂对照的多剂量研究，主要终点分析设置为患者接受治疗后第12个月，并设置开放标签扩展研究至第24个月。研究将招募约350名绝经后女性骨质疏松患者，主要研究终点为接受治疗后第12个月时腰椎骨密度（BMD）相较基线的百分比变化。次要终点包括在其他解剖部位和时间点的BMD百分比以及骨转换生化标志物的变化。

安济盛于2024年9月27日至30日在加拿大多伦多举行的2024年美国骨与矿物质研究学会（ASBMR）年会上展示了AGA2118的首次临床I期数据。

关于骨质疏松症

骨质疏松症被定义为一种系统性骨骼疾病，其特征是骨量低和骨微结构破坏，从而造成骨脆性增加和易发生骨折。由于人口老龄化和预期寿命延长，骨质疏松症已成为全球性流行病，特别是在老年妇女群体中高发。估计全球有超过2亿患者患有骨质疏松症。

尽管已有多种已获批的骨质疏松症治疗方法，但现有疗法在疗效和/或安全性方面仍存在诸多担忧。研究还表明，大多数重度骨质疏松症患者并未使用骨活性药物。因此，在开发新的骨质疏松症疗法方面，仍存在巨大的未满足的医疗需求。

关于 AGA2118

AGA2118 是一种靶向硬骨抑素和 DKK1 的双特异性抗体，目前正处于治疗骨质疏松症的临床开发阶段。硬骨抑素和 DKK1 是成骨细胞中 WNT 信号传导和骨代谢的两个关键负调控因子。通过同时靶向这两种蛋白，AGA2118 旨在防止其中任一种蛋白的代偿性增加，从而提高骨质疏松症患者的骨密度提升幅度。安济盛拥有该双特异性抗体的全部权益。

安济盛AGA2118 OLYMPUS项目旨在通过多年期纵向研究评估绝经后女性骨折风险。当前进行的评估AGA2118在绝经后低骨密度女性患者中有效性的临床II期试验名为ARTEMIS。

关于安济盛生物

安济盛生物，一家专注于骨骼、关节和肌肉重症疾病领域的创新药物研发公司。安济盛目前有3款生物大分子候选药物正处于临床研究阶段，旨在治疗骨质疏松症、成骨不全症（OI）和促进脊柱融合。安济盛生物以对骨骼肌肉系统疾病致病机制的科学洞见和在创新药物开发上积累的丰富成功经验，致力为患者带来优效和安全的全新治疗方案。

如需了解更多详情，请访问公司网站：www.angitiabio.com

前瞻性声明

本新闻稿由安济盛生物（以下简称“公司”、“我们”）发表，仅用作提供信息。前瞻性声明包括所有非历史事实的声明，在某些情况下可能使用“预期”、“期望”、“意图”、“计划”、“相信”、“继续”、“可能”、“潜在”、“可能”、“将”、“目标”或类似的词语表达和前述词语的否定性表达，但并非所有前瞻性声明都包含前述词语。   

这些前瞻性声明系公司基于截至这些声明发布之日公司对未来事务的现有业务基础、预期、假设和理解而作出的。这些声明不是对未来发展或其他方面的承诺或保证。 

这些声明涉及公司无法控制且难以预测的重大已知和未知风险、不确定性和其他因素，可能导致我们的实际结果、结果发生的时间或成果与前瞻性声明中明示或暗示的信息存在重大差异。我们预计后续事件和发展可能导致我们的预期和假设发生改变，但除有法律要求外，不论是出于新信息、未来事件或其他原因，我们均无义务更新或修订任何前瞻性陈述。 

除法律明确要求外，公司和/或其高管、董事、员工或代理不对提供的信息中有关前瞻性陈述的准确性和完整性承担责任。

Angitia Biopharmaceuticals Announces Dosing of First Patient in Phase 2 Clinical Trial of AGA2118 for the Treatment of Osteoporosis

Phase 2 study to be conducted in the US and EU

WOODLAND HILLS, California, USA, November 4, 2024 – Angitia Biopharmaceuticals, a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases, today announced the dosing of the first patient in ARTEMIS, its Phase 2 study of AGA2118, a bispecific antibody targeting sclerostin and DKK1, for the treatment of osteoporosis.

“The dosing of the first patient in our Phase 2 study marks an important milestone in the development of AGA2118 for patients with postmenopausal osteoporosis,” said Dr. Willard H. Dere, M.D., Chief Medical Officer of Angitia. “The data from this study will build on the first-in-human data on AGA2118 presented recently at ASBMR, which demonstrated rapid and robust gains in bone mineral density. We look forward to advancing this novel, differentiated therapy for the treatment of osteoporosis.”

The Phase 2 study is a randomized, double-blind, placebo-controlled, dose-ranging study with a primary analysis at Month 12 and an open-label extension through Month 24. The study will enroll approximately 350 postmenopausal women with osteoporosis, and the primary endpoint of the study is the percent change from baseline in bone mineral density (BMD) at the lumbar spine at 12 months. Secondary endpoints include percent change in BMD at additional anatomic locations and time points and the changes in biochemical markers of bone turnover.

Angitia presented first-in-human data on AGA2118 at the American Society for Bone and Mineral Research 2024 Annual Meeting, September 27-30, 2024, in Toronto, Canada.

About Osteoporosis

Osteoporosis is a systemic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture. Osteoporosis has become a global epidemic, especially for older women, due to an aging population and longer life expectancies. Estimates indicate that more than 200 million patients worldwide suffer from osteoporosis.

Although there are a number of approved therapies for osteoporosis, limitations remain regarding the efficacy and/or safety of each of these options. Research also indicates that most severely osteoporotic individuals do not receive a bone-active agent. As a result, a large unmet medical need remains for the development of new osteoporosis therapies.

About AGA2118

AGA2118 is a bispecific antibody that targets sclerostin and DKK1 and is in clinical development for the treatment of osteoporosis. Sclerostin and DKK1 are two critical, negative regulators of WNT signaling in osteoblasts and of bone metabolism. By targeting both proteins, AGA2118 is thought to prevent compensatory increase of either agent, aiming to improve the magnitude of bone mineral density gains in osteoporotic patients. Angitia wholly owns the bispecific antibody.

Angitia is developing AGA2118 in OLYMPUS (Osteoporosis Longitudinal multi-Year prograM to evaluate Postmenopausal women at risk for fractUreS), and the drug candidate is currently under investigation in the ARTEMIS Phase 2 study (A Phase 2 Randomized Trial Evaluating Efficacy of AGA2118 in PostMenopausal Women wIth Low Bone MasS).

About Angitia Biopharmaceuticals

Angitia Biopharmaceuticals is a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases. Angitia is currently studying 3 biologic product candidates in the clinic for the treatment of osteoporosis, osteogenesis imperfecta (OI), and spinal fusion. Leveraging the team's extensive experience and scientific acumen in novel drug development, Angitia is committed to providing groundbreaking therapies to satisfy key unmet medical needs.

Learn more at www.angitiabio.com.

Investor & Media Contact:

William Windham
Solebury Strategic Communications
wwindham@soleburystrat.com
646-378-2946

Forward-Looking Statement

This press release is prepared by Angitia (the “Company”, “We”) for informational purposes only. Forward-looking statements include all statements that are not historical facts, and in some cases, can be identified by terms such as “anticipate”, “expect”, “intend”, “plan”, “believe”, “continue”, “could”, “potential”, “may”, “will”, “goal” or similar expressions and the negatives of those terms. However, not all forward-looking statements contain these identifying words.

These forward-looking statements involve substantial known and unknown risks, uncertainties, and other factors that are beyond the Company’s control and are difficult to predict and may cause our actual results, timing of results, or achievements to be materially different from the information expressed or implied by these forward-looking statements. We anticipate that subsequent events and developments may cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law.

Except as expressly required by law, the Company and/or its officers, directors, employees, and agents shall not assume responsibility for the accuracy and completeness of the forward-looking statements in the information provided.

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