安济盛生物宣布AGA2115治疗成骨不全症的II期临床试验(IDUN)完成首例患者给药

安济盛生物今日宣布完成AGA2115，一种同时靶向硬骨抑素和DKK1的双特异性抗体，在治疗成骨不全症（Osteogenesis Imperfecta, OI）成人患者的II期临床试验(IDUN)中的首例患者给药。IDUN是一项II期、多中心、随机、双盲、安慰剂对照的临床试验，旨在评估AGA2115在成人OI患者中的安全性和有效性。该试验计划招募约80名年龄在18至75岁之间，患有I型、III型或IV型OI的患者。

Angitia Biopharmaceuticals Announces Dosing of First Participant in Phase 2 IDUN Trial of AGA2115 for the Treatment of Osteogenesis Imperfecta

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

Westlake Village, California, USA, January 12, 2026 – 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.

“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. 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.”

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. 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.

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

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 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.

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