Angitia Biopharmaceuticals has commenced its Phase 2 clinical trial, ARTEMIS, with the first patient dosed. The trial is evaluating AGA2118, a bispecific antibody, for the treatment of osteoporosis in postmenopausal women. This study aims to build upon the first-in-human data presented at ASBMR, which demonstrated rapid and robust gains in bone mineral density.
Phase 2 ARTEMIS Trial Design
The ARTEMIS trial is a randomized, double-blind, placebo-controlled, dose-ranging study. It will enroll approximately 350 postmenopausal women diagnosed with osteoporosis. The primary endpoint is the percent change from baseline in bone mineral density (BMD) at the lumbar spine at 12 months. Secondary endpoints include percent change in BMD at additional anatomic locations and time points, as well as changes in biochemical markers of bone turnover. An open-label extension will continue through Month 24.
AGA2118: A Novel Bispecific Antibody
AGA2118 is a bispecific antibody that simultaneously targets sclerostin and DKK1, two negative regulators of WNT signaling in osteoblasts and bone metabolism. By inhibiting both proteins, AGA2118 is designed to prevent compensatory increases of either agent, potentially leading to greater gains in bone mineral density compared to targeting either protein alone. Angitia Biopharmaceuticals wholly owns AGA2118 and is developing it within the OLYMPUS program (Osteoporosis Longitudinal multi-Year program to evaluate Postmenopausal women at risk for fractures).
Osteoporosis: An Unmet Medical Need
Osteoporosis is a systemic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue, leading to increased bone fragility and fracture risk. It is a global epidemic, affecting more than 200 million people worldwide, particularly older women. While several therapies are approved for osteoporosis, limitations persist regarding their efficacy and safety. Research indicates that a significant proportion of severely osteoporotic individuals do not receive any bone-active treatment, underscoring the substantial unmet medical need for new and improved osteoporosis therapies. Dr. Willard H. Dere, M.D., Chief Medical Officer of Angitia, stated that advancing this novel, differentiated therapy is a priority for the treatment of osteoporosis.
