安济盛宣布AGA2118治疗骨质疏松症临床II期试验完成首例患者给药

二期临床试验在美国和欧盟开展 

美国加州WOODLAND HILLS和中国广东广州- 2024年11月4日：安济盛生物，一家专注于骨骼、关节和肌肉重症疾病领域的创新药物研发公司，今日宣布完成AGA2118，一种同时靶向硬骨抑素和DKK1的双特异性抗体，在治疗骨质疏松症临床II期试验（ARTEMIS）中的首例患者给药。  

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WOODLAND HILLS, California, USA, November 4, 2024 – Angitia Biopharmaceuticals, a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases, today announced the dosing of the first patient in ARTEMIS, its Phase 2 study of AGA2118, a bispecific antibody targeting sclerostin and DKK1, for the treatment of osteoporosis.  

“The dosing of the first patient in our Phase 2 study marks an important milestone in the development of AGA2118 for patients with postmenopausal osteoporosis,” said Dr. Willard H. Dere, M.D., Chief Medical Officer of Angitia. “The data from this study will build on the first-in-human data on AGA2118 presented recently at ASBMR, which demonstrated rapid and robust gains in bone mineral density. We look forward to advancing this novel, differentiated therapy for the treatment of osteoporosis.” 

The Phase 2 study is a randomized, double-blind, placebo-controlled, dose-ranging study with a primary analysis at Month 12 and an open-label extension through Month 24. The study will enroll approximately 350 postmenopausal women with osteoporosis, and the primary endpoint of the study 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 and the changes in biochemical markers of bone turnover.  

Angitia presented first-in-human data on AGA2118 at the American Society for Bone and Mineral Research 2024 Annual Meeting, September 27-30, 2024, in Toronto, Canada.  

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), and the drug candidate is currently under investigation in the ARTEMIS Phase 2 study (A Phase 2 Randomized Trial Evaluating Efficacy of AGA2118 in PostMenopausal Women wIth Low Bone MasS).