安济盛生物宣布AGA2118临床II期骨质疏松症试验（ARTEMIS）完成参与者入组

安济盛生物今日宣布，AGA2118，一种同时靶向硬骨抑素和DKK1的双特异性抗体，在一项评估治疗骨质疏松症的临床II期试验(ARTEMIS)中已完成全部参与者入组。

Angitia Biopharmaceuticals Completes Enrollment of Phase 2 ARTEMIS Trial Evaluating AGA2118 for the Treatment of Osteoporosis

- Company expects topline data from the study in 2027

Westlake Village, California, USA, January 5, 2026 – Angitia Biopharmaceuticals, a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases, today announced the completion of enrollment in the Phase 2 ARTEMIS trial evaluating AGA2118, a bispecific antibody targeting sclerostin and Dickkopf-1 (DKK1), for the treatment of osteoporosis.

“We are pleased to announce the successful completion of enrollment in the Phase 2 ARTEMIS trial evaluating AGA2118, our bispecific antibody for the treatment of osteoporosis,” said Dr. Willard H. Dere, M.D., Chief Medical Officer of Angitia. “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 management.”

This Phase 2 trial is a multi-center, international, randomized, double-blind, placebo-controlled, parallel group, dose-ranging trial with a primary analysis at Month 12 and an open-label extension through Month 24. The trial enrolled 379 postmenopausal women with osteoporosis, and the primary endpoint of the trial is 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.

“Osteoporosis 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, M.D., 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. We aim to develop a therapy that addresses the underlying biology of osteoporosis and improves patient outcomes on a global scale.”

The open-label extension will evaluate both the off-treatment effect of AGA2118 as well as the effect of continuous treatment for two years. Topline results from ARTEMIS are expected in 2027.

AGA2118 is a bispecific antibody that targets sclerostin and DKK1 and is in clinical development for the treatment of osteoporosis. Sclerostin and DKK1 are two critical, negative regulators of WNT signaling in osteoblasts and of bone metabolism. By targeting both proteins, AGA2118 is thought to prevent compensatory increase of either agent, aiming to improve the magnitude of bone mineral density gains in osteoporotic patients. Angitia wholly owns the bispecific antibody.

Angitia is developing AGA2118 in OLYMPUS (Osteoporosis Longitudinal multi-Year prograM to evaluate Postmenopausal women at risk for fractUreS), which is currently under investigation in the ARTEMIS Phase 2 trial (A Phase 2 Randomized Trial Evaluating Efficacy of AGA2118 in PostMenopausal Women wIth Low Bone MasS).

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