Angitia Biopharma Unveils Initial Human Data on AGA2118 for Osteoporosis at ASBMR 2024

Angitia Biopharmaceuticals, a company engaged in developing innovative treatments for musculoskeletal diseases, recently presented data on AGA2118 at the American Society for Bone and Mineral Research 2024 Annual Meeting. AGA2118, a bispecific antibody targeting sclerostin and DKK1, has shown promise in treating osteoporosis by enhancing bone formation, reducing bone resorption, and improving bone mineral density (BMD) and bone strength.

David Ke, M.D., the Chairman and CEO of Angitia, emphasized that AGA2118 is the first bispecific antibody targeting two crucial regulators of bone metabolism to reach clinical trials. He highlighted that the initial human trials showcased clinical proof-of-concept, with the treatment being well-tolerated and demonstrating significant increases in BMD in both men and postmenopausal women. Angitia plans to engage with regulatory bodies to further the development of AGA2118.

The first-in-human trial involved 88 participants, including men and otherwise healthy postmenopausal women, who received either AGA2118 or a placebo. The participants were administered the treatment subcutaneously or intravenously at different dosage levels. In the single ascending dose (SAD) cohort, participants received up to 15 mg/kg and were monitored for 85 days. In the multiple ascending dose (MAD) cohort, participants received up to 12 mg/kg every four weeks, totaling three doses, and were followed for 169 days. The treatment was safe and well-tolerated at all dose levels, with adverse events being comparable between the treatment and placebo groups. Notably, no serious adverse events related to the treatment were observed.

Clinical activity was noted through dose-dependent increases in bone formation markers such as P1NP, BSAP, and osteocalcin, alongside decreases in the bone resorption marker CTX-1. Both SAD and MAD cohorts exhibited dose- and exposure-dependent increases in BMD in the lumbar spine, total hip, and femoral neck.

Matthew Drake, M.D., Ph.D., an Associate Professor of Medicine at the Mayo Clinic, commented on the rapid and robust BMD and biomarker responses observed in the trial, underscoring the potential of AGA2118 as a new treatment option for skeletal diseases. He also noted that the pharmacokinetics and safety profile of AGA2118 support further development.

In addition to the primary trial data, Angitia presented findings from a non-human primate (NHP) model of osteoporosis, demonstrating consistent results between preclinical models and human trials. These presentations included a second oral presentation and two posters, covering AGA2118's pharmacokinetics in both NHPs and humans, and long-term follow-up in NHPs.

Osteoporosis is a systemic skeletal condition characterized by low bone mass and deterioration of bone tissue, leading to increased fragility and fracture risk. It is a significant global health issue, particularly among older women, due to aging populations and longer life expectancies. Despite the availability of several approved therapies, there remain limitations in their efficacy and safety, leaving a substantial unmet need for new treatment options.

AGA2118 aims to address this need by targeting both sclerostin and DKK1, crucial regulators of bone metabolism. By inhibiting these two proteins, AGA2118 is designed to prevent compensatory increases of either agent, thereby enhancing bone mineral density gains in patients with osteoporosis. Angitia Biopharmaceuticals, which wholly owns AGA2118, continues to focus on developing groundbreaking therapies for serious musculoskeletal diseases. The company is currently studying three biologic product candidates for the treatment of osteoporosis, osteogenesis imperfecta, and spinal fusion.