- AGA2115 also received Orphan Drug Designation from European Medicines Agency

- AGA2115 还获得了欧洲药品管理局的孤儿药资格认定

Westlake Village,

西湖村，

California, USA

美国加利福尼亚州

,

，

June 12, 2025

2025年6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 topline results from its first in human (FIH) study of AGA2115, its bispecific antibody under development for the treatment of Osteogenesis Imperfecta (OI).

– 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创新疗法的临床阶段生物技术公司，今天公布了其在研双特异性抗体AGA2115用于治疗成骨不全（OI）的首次人体（FIH）研究的顶线结果。

The Phase 1, randomized, double-blind, and placebo-controlled study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of AGA2115 in adult healthy male and female volunteers..

第一阶段的随机、双盲和安慰剂对照研究评估了AGA2115在成年健康男性和女性志愿者中的安全性、耐受性、药代动力学和药效学。

AGA2115 is a first-in-class bispecific antibody developed by Angitia. This FIH study of AGA2115 demonstrated a favorable safety profile with a rapid increase in bone formation and simultaneous decrease in bone resorption, leading to robust increases in bone mineral density (BMD) in both single and multiple ascending-dose cohorts..

AGA2115是Angitia开发的首例双特异性抗体。这项针对AGA2115的首次人体研究表明，其安全性良好，能够快速促进骨形成并同时减少骨吸收，从而在单次和多次递增剂量队列中均显著提升骨矿物质密度（BMD）。

Dr. Willard H. Dere, M.D., Chief Medical Officer of Angitia, commented, “The top-line results from our Phase 1 study highlight the promise of AGA2115 as a novel therapeutic approach for patients living with osteogenesis imperfecta, a progressive and debilitating disease. These early findings suggest that AGA2115 has the potential to alter the course of OI and address key aspects of disease burden.

安吉蒂亚公司首席医疗官威尔拉德·H·德雷医学博士评论道：“我们1期研究的初步结果突显了AGA2115作为治疗成骨不全症患者的新型疗法的潜力，成骨不全症是一种进行性和衰竭性疾病。这些早期发现表明，AGA2115有潜力改变OI的病程，并解决疾病负担的关键方面。”

We are encouraged by the emerging data and are committed to advancing AGA2115 through clinical development in close collaboration with global regulatory agencies, with the goal of bringing meaningful innovation to OI patients and their families.” .

我们对新兴数据感到鼓舞，并致力于与全球监管机构密切合作，推动AGA2115的临床开发，目标是为OI患者及其家庭带来有意义的创新。

Angitia also received confirmation that the European Medicines Agency (EMA) granted Orphan Drug Designation (ODD) to AGA2115. The EMA grants ODD to medicines intended for the treatment, prevention, or diagnosis of rare, life-threatening or chronically debilitating diseases without a satisfactory treatment available.

安吉提亚还收到确认，欧洲药品管理局 (EMA) 授予 AGA2115 孤儿药资格认定 (ODD)。EMA 会为用于治疗、预防或诊断罕见、危及生命或慢性衰弱性疾病且尚无满意治疗方案的药物授予 ODD 资格。

ODD grants certain incentives, including increased regulatory engagement and market exclusivity..

ODD 提供某些激励措施，包括加强监管参与和市场独占权。

AGA2115 is a first-in-class bispecific antibody developed by Angitia. The Company intends to initiate a Phase 2 study of AGA2115 for the treatment of OI in adult patients, with additional studies in pediatric patients to follow.'

AGA2115 是 Angitia 开发的首例双特异性抗体。该公司计划启动 AGA2115 用于治疗成年 OI 患者的二期临床试验，并将在之后开展针对儿童患者的进一步研究。

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 occurs in approximately 1 in 15,000 births, with between 20,000 to 50,000 affected individuals in the United States.

成骨不全症（OI）是一种遗传性结缔组织疾病，其病理生理机制由胶原代谢异常引起，导致骨骼畸形、骨脆弱、骨量减少以及不同程度的骨外症状。成骨不全症在大约每15,000例新生儿中发生一次，在美国约有20,000至50,000名患者受到影响。

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时期出现，常伴有频繁且反复发生的骨折，通常由极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，或在严重情况下导致围产期死亡。

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 approved therapies for the treatment of OI.

目前尚无获批的OI治疗方法。

About AGA2115

关于AGA2115

AGA2115 is a first-in-class, 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 with an ODD.

AGA2115 是一种用于治疗成骨不全症的首创双特异性抗体。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)。

A Phase 1, first-in-human, randomized, double-blind, placebo-controlled, single and multiple ascending-dose study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of AGA2115 in adult healthy volunteers. A Phase 2 study is planned to evaluate the efficacy of AGA2115 in adult OI patients, with additional studies in pediatric patients to follow..

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研究评估了AGA2115在成年健康志愿者中的安全性、耐受性、药代动力学和药效学。计划进行一项二期研究以评估AGA2115在成年OI患者中的疗效，并随后开展针对儿科患者的其他研究。

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 studying three biologic product candidates in the clinic for the treatment of osteoporosis, osteogenesis imperfecta (OI), 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研究三种生物制品候选药物，用于治疗骨质疏松症、成骨不全症（OI）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/2025/06/12/3098209/0/en/Angitia-Biopharmaceuticals-Announces-Topline-Results-from-First-in-Human-Study-of-AGA2115-A-Bispecific-Antibody-for-the-Treatment-of-Osteogenesis-Imperfecta.html

https://www.globenewswire.com/news-release/2025/06/12/3098209/0/zh/Angitia-生物制药公司宣布了AGA2115的首次人体研究的顶线结果，AGA2115是一种用于治疗成骨不全症的双特异性抗体.html

Learn more at

了解更多信息，请访问

www.angitiabio.com

www.angitiabio.com

.

。

Investor & Media Contact:

投资者和媒体联系：

William Windham

威廉·温德姆

Solebury Strategic Communications

索勒伯里战略传播

wwindham@soleburystrat.com

温德姆@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.

本新闻稿由安吉蒂亚生物制药公司（“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”或类似表述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，并非所有前瞻性声明都包含这些识别词。

These forward-looking statements involve substantial known and unknown risks and uncertainties, including the risk that results in earlier clinical 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的风险和不确定性，包括早期临床研究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所需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，我们不承担更新或修改任何前瞻性陈述的义务，不论是由于新信息、未来事件或其他原因，除非法律另有要求。

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，公司及其高级职员、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。