- Phase 2 trial of adults with Osteogenesis Imperfecta (OI) is enrolling patients in the US and EU

- 针对成年骨质疏松症（OI）患者的二期临床试验正在美国和欧盟招募患者

Westlake Village,

西湖村，

California, USA

美国加利福尼亚州

, January 12, 2026

，2026年1月12日

– 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 the Phase 2 IDUN trial evaluating AGA2115, a bispecific antibody targeting Dickkopf-1 (DKK1) and sclerostin, for the treatment of osteogenesis imperfecta (OI) in adults.

– Angitia生物制药公司，一家专注于发现和开发针对严重肌肉骨骼疾病的创新疗法的临床阶段生物技术公司，今天宣布在评估AGA2115（一种靶向Dickkopf-1（DKK1）和硬化蛋白的双特异性抗体）用于治疗成人成骨不全症（OI）的2期IDUN试验中，已对首位患者进行了给药。

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“The dosing of the first participant in our Phase 2 trial marks an important step forward in our development of AGA2115 for the treatment of osteogenesis imperfecta,” said Dr. Willard H. Dere, M.D., Chief Medical Officer of Angitia. “The data from this trial will build upon the AGA2115 first-in-human data presented at ASBMR in September 2025, which demonstrated rapid and robust gains in bone mineral density.

“我们二期试验中第一名受试者的给药标志着我们在开发AGA2115用于治疗成骨不全症方面迈出了重要的一步，”Angitia首席医学官Willard H. Dere博士说道。“这项试验的数据将基于2025年9月在ASBMR上展示的AGA2115首次人体试验数据，该数据显示出骨密度快速且显著的增加。”

We look forward to learning more about the effect of AGA2115’s novel mechanism in OI, and we hope to replicate the exciting improvements in bone quality seen in our preclinical studies.”.

我们期待进一步了解AGA2115在OI中的新机制效果，并希望能够重现我们在临床前研究中观察到的令人兴奋的骨质量改善。”

IDUN is a Phase 2, multi-center, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of AGA2115 in adults with OI. The trial will enroll approximately 80 patients aged 18 to 75 years with Type I, III, or IV OI. The primary analysis will be at Month 12, followed by a 12 month open-label extension and a 3-month follow-up, with the final analysis at Month 27.

IDUN 是一项二期、多中心、随机、双盲、安慰剂对照试验，评估AGA2115在患有OI的成人中的安全性和有效性。该试验将招募大约80名18至75岁患有I型、III型或IV型OI的患者。主要分析将在第12个月进行，随后是为期12个月的开放标签扩展和3个月的随访，最终分析将在第27个月进行。

The primary endpoint is percent change from baseline in lumbar spine bone mineral density (BMD) at Month 12. Secondary endpoints include percent change from baseline in BMD at other anatomical locations, fracture data, and biomarkers of bone turnover. In a subset of patients, the Company will also obtain HRpQCT and bone biopsies to evaluate changes in bone quality alongside changes in BMD..

主要终点是第12个月时腰椎骨矿物质密度（BMD）相对于基线的百分比变化。次要终点包括其他解剖部位BMD相对于基线的百分比变化、骨折数据以及骨转换的生物标志物。在部分患者中，公司还将获取HRpQCT和骨活检，以评估骨质量变化与BMD变化的关系。

Angitia presented first-in-human data on AGA2115 in healthy volunteers at the American Society for Bone and Mineral Research (ASBMR) 2025 Annual Meeting.

Angitia 在 2025 年美国骨与矿物研究学会 (ASBMR) 年会上公布了 AGA2115 在健康志愿者中的首次人体试验数据。

About Osteogenesis Imperfecta

关于成骨不全症

Osteogenesis imperfecta (OI) is an inherited connective tissue disorder with pathophysiology driven by abnormal collagen metabolism resulting in skeletal deformity, bone fragility, reduced bone mass, and variable extra-skeletal symptoms. OI affects approximately 20,000 to 50,000 individuals in the United States.

成骨不全症 (OI) 是一种遗传性结缔组织疾病，其病理生理学由异常的胶原代谢驱动，导致骨骼畸形、骨脆弱、骨量减少以及不同程度的骨骼外症状。在美国，大约有 20,000 到 50,000 人受成骨不全症影响。

As a rare pediatric disease, OI ranges in severity from mild to severe and life-threatening. Disease manifestations occur in the neonatal and pediatric age groups, presenting with frequent and recurrent fractures, often elicited by little or no trauma. Severe OI cases manifest with multiple debilitating fractures resulting in loss of independent movement, deformity, and stunted growth, or, in severe cases, perinatal mortality.

作为一种罕见的儿科疾病，OI 的严重程度从轻微到严重甚至危及生命不等。该疾病的表现在新生儿和儿童期出现，常表现为频繁和反复的骨折，通常由很小的创伤或无创伤引发。严重的 OI 病例表现为多处致残性骨折，导致独立行动能力丧失、畸形和生长迟缓，或者在严重情况下会导致围产期死亡。

Patients also suffer from muscle weakness, joint laxity, dental issues, hearing loss, and skeletal malformations. .

患者还遭受肌肉无力、关节松弛、牙齿问题、听力损失和骨骼畸形的困扰。

There are no FDA-approved therapies for the treatment of OI.

目前尚无FDA批准的OI治疗疗法。

About AGA2115

关于 AGA2115

AGA2115 is a bispecific antibody being developed for the treatment of osteogenesis imperfecta. The U.S. Food and Drug Administration (FDA) has granted AGA2115 Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD), and the EMA has also granted AGA2115 an ODD. A Phase 1, first-in-human, randomized, double-blind, placebo-controlled, single and multiple ascending-dose trial evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of AGA2115 in adult healthy volunteers.

AGA2115是一种正在开发用于治疗成骨不全症的双特异性抗体。美国食品药品监督管理局（FDA）已授予AGA2115孤儿药资格（ODD）和罕见儿科疾病资格（RPDD），欧洲药品管理局（EMA）也授予了AGA2115孤儿药资格（ODD）。一项一期、首次人体、随机、双盲、安慰剂对照、单次和多次递增剂量试验评估了AGA2115在健康成年志愿者中的安全性、耐受性、药代动力学和药效学。

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AGA2115 is currently under investigation in the Phase 2 IDUN trial (Osteogenesis Imperfecta Trial of AGA2115 for ADUlts with COL1A1 and/or COL1A2 GeNetic Variations), which is a multi-center, international, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging trial to evaluate the safety and efficacy of AGA2115 in adults with OI..

AGA2115目前正在第二阶段的IDUN试验（针对携带COL1A1和/或COL1A2基因变异的成年骨质疏松症患者的AGA2115试验）中进行研究，这是一项多中心、国际性、随机、双盲、安慰剂对照、平行组、剂量范围试验，旨在评估AGA2115在成年骨质疏松症患者中的安全性和有效性。

About Angitia Biopharmaceuticals

关于Angitia生物制药公司

Angitia Biopharmaceuticals is a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases. Angitia is currently developing three biologic product candidates (AGA2118, AGA2115, AGA111) in the clinic for the treatment of osteoporosis, osteogenesis imperfecta, and spinal fusion.

安吉提亚生物制药是一家临床阶段的生物技术公司，专注于发现和开发用于治疗严重肌肉骨骼疾病的创新疗法。安吉提亚目前正在临床中开发三种生物制品候选药物（AGA2118、AGA2115、AGA111），用于治疗骨质疏松症、成骨不全和脊柱融合。

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..

利用团队在新药开发方面的丰富经验和科学智慧，Angitia 致力于提供突破性的疗法，以满足关键的未满足医疗需求。

Globe Newswire:

全球新闻网：

https://www.globenewswire.com/news-release/2026/01/12/3216764/0/en/Angitia-Biopharmaceuticals-Announces-Dosing-of-First-Participant-in-Phase-2-IDUN-Trial-of-AGA2115-for-the-Treatment-of-Osteogenesis-Imperfecta.html

https://www.globenewswire.com/news-release/2026/01/12/3216764/0/en/Angitia生物制药公司宣布在AGA2115治疗成骨不全症的2期IDUN试验中首次对参与者进行给药.html

Learn more at

了解更多内容，请访问

www.angitiabio.com

www.angitiabio.com

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Investor & Media Contact:

投资者和媒体联系：

William Windham

威廉·温德姆

Solebury Strategic Communications

索尔伯里战略传播公司

wwindham@soleburystrat.com

wwindham@soleburystrat.com

646-378-2946

646-378-2946

Forward-Looking Statements

前瞻性声明

This press release is prepared by Angitia Biopharmaceuticals (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.

本新闻稿由Angitia生物制药公司（“公司”，“我们”）编制，仅供参考。前瞻性声明包括所有非历史事实的声明，在某些情况下，可以通过“预期”、“预计”、“打算”、“计划”、“相信”、“继续”、“可能”、“潜在”、“或许”、“将”、“目标”或类似表达及这些术语的否定形式来识别。

However, not all forward-looking statements contain these identifying words..

然而，并非所有前瞻性陈述都包含这些标识性词语。

These forward-looking statements involve substantial known and unknown risks and uncertainties, including the risk that results in earlier clinical trials and preclinical studies may not be indicative of future results and that any product candidates may not ultimately obtain required approvals or meaningfully improve patient outcomes, 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.

这些前瞻性陈述涉及大量的已知和未知风险及不确定性，包括早期临床试验和临床前研究的结果可能无法预示未来结果的风险，以及任何候选产品最终可能无法获得必要批准或显著改善患者预后的风险，以及其他超出公司控制范围、难以预测的因素，可能导致我们的实际结果、结果的时间或成就与这些前瞻性陈述中明示或暗示的信息存在重大差异。

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. .

我们预计，随后发生的事件和发展可能会导致我们的预期和假设发生变化，我们没有义务更新或修改任何前瞻性声明，无论是由于新信息、未来事件或其他原因，除非法律可能要求。

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.

除非法律明确要求，公司及其管理人员、董事、员工和代理人不对所提供信息中的前瞻性陈述的准确性和完整性承担责任。