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Angitia Biopharmaceuticals Announces Topline Results from First in Human Study of AGA2118

WOODLAND HILLS, California, USAMay 16, 2024 – Angitia Biopharmaceuticals, a global, clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases, today announced positive top-line results from its first in human (FIH) study of AGA2118. The study, entitled “A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Doses Study to Evaluate the Safety, Tolerability, Absolute Bioavailability, Pharmacokinetics, and Pharmacodynamics of AGA2118 in Men and Postmenopausal Women”, demonstrates an excellent safety and tolerability profile, as well as preliminary efficacy in increasing bone mineral density (BMD) after single and multiple dose administrations.

AGA2118 is a first-in-class bispecific antibody developed by Angitia. This FIH study of AGA2118 demonstrated a favorable safety profile with rapid increase in bone formation and simultaneous decrease in bone resorption, leading to a robust increase in BMD at the lumbar spine, total hip, and femoral neck. The results of these clinical assessments indicate that AGA2118 has the potential to be a safe and effective treatment for postmenopausal osteoporosis and male osteoporosis, and warrants further evaluation in randomized, controlled clinical trials.

Dr. Willard H. Dere, M.D., Chief Medical Officer of Angitia, commented, “The top-line results of the AGA2118 Phase I study demonstrate the potential of AGA2118 for the treatment of osteoporotic patients at high risk of fragility fractures and other conditions associated with low bone mass and poor bone structure. These encouraging data provide strong evidence to support continuing clinical development of AGA2118. We plan to present the detailed clinical results at future scientific meetings. Angitia is looking forward to working with regulatory agencies around the globe and advancing this exciting drug candidate to help patients worldwide.”


About Osteoporosis

Osteoporosis is defined as a systemic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture. Osteoporosis has become a global epidemic, especially for older women, due to an aging population and longer life expectancies. Estimates indicate that more than 200 million patients worldwide suffer from osteoporosis.

Although there are a number of approved therapies for osteoporosis, limitations remain regarding the efficacy and/or safety of each of these options. Research also indicates that the majority of severely osteoporotic individuals do not receive a bone-active agent. As a result, a large unmet medical need remains for the development of new osteoporosis therapies.

About AGA2118

AGA2118 is a bispecific antibody developed and wholly-owned by Angitia. AGA2118 targets two critical factors involved in bone metabolism, aiming to improve the duration and magnitude of BMD gain in osteoporosis. AGA2118 is being studied for clinical development in osteoporosis.

About Angitia Biopharmaceuticals

Angitia Biopharmaceuticals is a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases. 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.

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Solebury Strategic Communications

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