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, Calif., Jan. 12, 2026 (GLOBE NEWSWIRE) -- 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.

About Osteogenesis Imperfecta

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

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

About 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 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.

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 developing three biologic product candidates (AGA2118, AGA2115, AGA111) in the clinic for the treatment of osteoporosis, osteogenesis imperfecta, 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

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