Angitia Biopharmaceuticals Presents First-in-Human Data on AGA2115 for Osteogenesis Imperfecta at ASBMR 2025
• Clinical data demonstrated administration of AGA2115 drove dose-dependent increases in bone mineral density
• The Company and collaborators also presented data from non-human primate and mouse models
WESTLAKE VILLAGE, Calif., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Angitia Biopharmaceuticals, a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases, today announced data from its ongoing program evaluating AGA2115 for the treatment of osteogenesis imperfecta (OI) at the American Society for Bone and Mineral Research 2025 Annual Meeting (ASBMR) September 5-8, 2025, in Seattle, WA. Administration of AGA2115, a bispecific antibody targeting both sclerostin and DKK1, led to rapid and durable increases in bone formation, decreases in bone resorption, and improvements in bone mineral density (BMD) in humans. The Company also presented multiple abstracts showcasing data from non-human primates (NHPs) and two mouse models (oim/oim and Brtl/+), which demonstrated improvements in bone density, strength, and organization following treatment with a sclerostin/DKK1 bispecific antibody.
“The results of our first-in-human trial demonstrate favorable pharmacodynamic effects and modulation of disease-relevant biomarkers for AGA2115 in healthy adult volunteers,” said David Ke, M.D., Chairman and Chief Executive Officer of Angitia. “Together with extensive preclinical data showing improvements in bone mass, bone quality, and resulting bone strength, these findings provide strong evidence that AGA2115 has the potential to deliver meaningful therapeutic benefit in the OI population. We are eager to explore the effects in patients as we advance in the clinic.”
The data underscore the favorable profile of AGA2115 as a candidate for the treatment of OI and provide meaningful insight into the drug candidate’s novel mechanism of action. In a first-in-human (FIH) study, 72 healthy volunteers received AGA2115 or placebo (randomized 3:1) subcutaneously (SC), or intravenously in a single cohort of 8 participants to evaluate bioavailability. Participants received a single dose of AGA2115 up to 30 mg/kg or multiple doses of AGA2115 up to 20 mg/kg every 4 weeks for a total of three doses. Participants were followed for 85 days in the single ascending dose (SAD) cohort and 169 days in the multiple ascending dose (MAD) cohort. AGA2115 was safe and well-tolerated at all dose levels tested, with adverse events balanced between treatment and placebo. No treatment-related serious adverse events (SAEs) were reported.
In addition to safety, the Company observed substantial clinical activity in healthy volunteers. In the SAD portion of the trial, at the highest dose, a single SC injection of AGA2115 led to a mean increase of 9% in lumbar spine BMD at 3 months. In the MAD portion of the trial, at the highest dose, three monthly SC injections of AGA2115 led to mean increases of 14.4% in lumbar spine BMD and 3.6% in total hip BMD at 6 months.
“We are excited to present these data showcasing the safety and tolerability of AGA2115 in human participants,” said Eric Orwoll, M.D., Professor of Medicine at Oregon Health and Sciences University, Division of Endocrinology, Diabetes, and Clinical Nutrition. “The cumulative data, including bone mineral density and biomarkers of bone formation and resorption support the further development of AGA2115 in the clinic.”
In addition to the FIH trial, Angitia presented preclinical work supporting the OI program at ASBMR, including a poster from a collaborator, the Willie Laboratory at the Shriners Hospital for Children, Research Center. These presentations highlighted data in NHPs and two mouse models (oim/oim and Brtl/+), as well as pharmacokinetic (PK) findings in both NHPs and humans. The pathophysiology of each mouse model is consistent with the symptoms observed in human OI patients, including collagen disorganization and weak, low-quality bone.
In the two mouse models, mice were treated subcutaneously with a placebo or with a surrogate rodent bispecific antibody (rbsAb) that neutralizes both DKK1 and sclerostin. The study demonstrated that rbsAb significantly reduced fractures in severe oim/oim mice and simultaneously increased growth plate width and long bone growth, enlarged mid-femur cortical bone area, and enhanced mechanical parameters. In addition, findings revealed improvement in organized collagen matrix. In the Brtl/+ model, mice treated with rbsAb saw improvements in both trabecular and cortical bone mass, including greater cross-sectional area in the long bones, with subsequent enhanced mechanical properties of bone stiffness and maximum load. Both models provide evidence that a bispecific antibody targeting DKK1 and sclerostin can improve bone structural and material properties.
“The strength of these findings provides compelling evidence that neutralizing both DKK1 and sclerostin improves bone mass, architecture, and strength, while also reducing spontaneous fractures,” said Bettina Willie, Ph.D., Professor at McGill University.
The data presented at ASBMR, including preclinical models and FIH results, highlights the strong foundation supporting AGA2115’s development for the treatment of OI. With clinical findings consistent with preclinical results and a PK profile favorable for future studies, Angitia is well positioned to advance this novel therapy toward patients in need.
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 occurs in approximately 1 in 15,000 births, with between 20,000 to 50,000 affected 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 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 an 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.
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 three 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.
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