Angitia Biopharmaceuticals Completes Enrollment in Phase 2 Trial of Dual-Target Osteoporosis Therapy AGA2118
核心洞察
Angitia Biopharmaceuticals has completed enrollment of 379 postmenopausal women with osteoporosis (搜索) in its Phase 2 ARTEMIS trial evaluating AGA2118, a bispecific antibody targeting sclerostin (搜索) and DKK1 (搜索).
The randomized, double-blind, placebo-controlled trial will assess bone mineral density changes at the lumbar spine as its primary endpoint, with topline results expected in 2027.
AGA2118 represents a novel dual-targeting approach designed to prevent compensatory increases in bone metabolism regulators and potentially improve treatment outcomes for the more than 200 million osteoporosis (搜索) patients worldwide.
Angitia Biopharmaceuticals announced the completion of enrollment in its Phase 2 ARTEMIS trial evaluating AGA2118, a bispecific antibody targeting both sclerostin (搜索) and Dickkopf-1 (搜索) (DKK1 (搜索)) for osteoporosis (搜索) treatment. The clinical-stage biotechnology company enrolled 379 postmenopausal women with osteoporosis in this multi-center, international study, with topline results expected in 2027.
Novel Dual-Target Mechanism
AGA2118 represents an innovative approach to osteoporosis (搜索) treatment by simultaneously targeting sclerostin (搜索) and DKK1 (搜索), two critical negative regulators of WNT signaling in osteoblasts and bone metabolism. According to Angitia, this dual-targeting strategy is designed to prevent compensatory increases of either protein, potentially improving the magnitude of bone mineral density gains in osteoporotic patients compared to single-target therapies.
"We expect the ARTEMIS trial to generate critical data on the safety and efficacy of AGA2118, and we look forward to advancing this innovative therapeutic candidate that has the potential to address significant unmet needs in osteoporosis (搜索) management," said Dr. Willard H. Dere, Chief Medical Officer of Angitia.
Trial Design and Endpoints
The Phase 2 ARTEMIS trial follows a randomized, double-blind, placebo-controlled, parallel group, dose-ranging design with a primary analysis at Month 12 and an open-label extension through Month 24. The primary endpoint measures the percent change from baseline in bone mineral density (BMD) at the lumbar spine at Month 12.
Secondary endpoints include percent change from baseline in BMD at additional anatomic locations and time points, as well as changes in biochemical markers of bone turnover. The open-label extension will evaluate both the off-treatment effect of AGA2118 and the effect of continuous treatment for two years.
Addressing Global Unmet Need
Osteoporosis (搜索) affects more than 200 million people worldwide, characterized by low bone mass and microarchitectural deterioration of bone tissue leading to enhanced bone fragility and increased fracture risk. The disease has become a global epidemic, particularly affecting older women due to aging populations and longer life expectancies.
"Osteoporosis (搜索) is a widespread disease affecting more than 200 million people worldwide, creating an urgent need for more effective, FDA-approved therapies," said Dr. David Ke, Chief Executive Officer of Angitia. "We believe the completion of enrollment in the ARTEMIS trial brings us one step closer to delivering a novel, dual-targeting treatment to the millions of patients who are not adequately treated with currently available therapeutics."
Despite existing approved therapies for osteoporosis (搜索), limitations remain regarding the efficacy and safety of current options. Research indicates that most severely osteoporotic individuals do not receive bone-active agents, highlighting the substantial unmet medical need for new osteoporosis therapies.
Development Program
AGA2118 is being developed within Angitia's OLYMPUS program (Osteoporosis (搜索) Longitudinal multi-Year prograM to evaluate Postmenopausal women at risk for fractUreS). The company wholly owns this bispecific antibody and is currently developing three biologic product candidates for treating osteoporosis, osteogenesis imperfecta (搜索), and spinal fusion.