June 28th, 2022: Angitia Biopharmaceuticals ("Angitia"), a global company dedicated in the discovery and development of novel therapies for serious musculoskeletal diseases, is delighted to announce that the first subject has been dosed in the first-in-human (FIH) trial of its new drug candidate AGA2118. The FIH trial is a Phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, absolute bioavailability, pharmacokinetics, and pharmacodynamics of AGA2118 in postmenopausal women.
AGA2118 is a first-in-class (FIC) antibody discovered by Angitia. Data from preclinical studies including safety, efficacy and pharmacokinetics in animal models demonstrate the potential of AGA2118 for the treatment of sever osteoporosis and other conditions associated with low bone mass and abnormal bone metabolism, such as cancer-induced bone diseases, and abnormal healing of fractures.
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. Although it is seen in all age groups, genders, and races, it is more common in the older population and in women. With an aging population and a longer life expectancy, osteoporosis is increasingly becoming a global epidemic. It has been estimated that more than 200 million patients worldwide suffer from osteoporosis and its related fragility hip fractures.
Whereas the current available therapies have provided some levels of efficacy for osteoporotic patients, there are limitations with each of these options regarding efficacy and/or safety. Researches indicate that the majority of sever osteoporotic patients have not been treated with bone-targeting therapeutic agents (Gromer et al., J Gen Intern Med, DOI: 10.1007/s11606-021-06938-8; 2021). There is a large unmet medical need for the development of new anti-osteoporotic therapies. AGA2118 has the potential to become a bone-targeting therapy with superior efficacy and better safety profile for sever osteoporosis and other conditions associated with low bone mass and high risk of skeletal fractures.
Angitia Biopharmaceuticals is a global biotechnology company focusing on discovering and developing innovative therapeutics for serious musculoskeletal diseases. Angitia was founded by seasoned drug hunters with sound experience from top pharmaceutical companies in drug discovery, preclinical research, and clinical development in musculoskeletal disorders. With the team's well-acknowledged expertise and track records, Angitia is positioned as the leading biopharmaceutical company in musculoskeletal diseases by bringing transformative therapeutics to patients in need.
For more information, please visit us at: https://www.angitiabio.com/