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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.
2024年11月4日,美国加利福尼亚州WOODLAND HILLS–Angitia Biopharmaceuticals是一家临床阶段生物技术公司,专注于发现和开发针对严重肌肉骨骼疾病的创新疗法,今天宣布为ARTEMIS的第一名患者服用药物,这是其针对硬化蛋白和DKK1的双特异性抗体AGA2118的2期研究,用于治疗骨质疏松症。“在我们的第二阶段研究中,第一位患者的剂量标志着AGA2118在绝经后骨质疏松症患者中的发展具有重要的里程碑意义,”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.
医学博士威拉德·H·德里(WillardH.Dere),Angitia首席医疗官。“这项研究的数据将建立在最近在ASBMR上提交的关于AGA2118的首次人体数据的基础上,该数据显示了骨矿物质密度的快速而强劲的增加。我们期待着推进这种治疗骨质疏松症的新型差异化疗法。”第二阶段研究是一项随机,双盲,安慰剂对照,剂量范围研究,在第12个月进行初步分析,并在第24个月进行开放标签延长。
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.About OsteoporosisOsteoporosis is a systemic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue, with a consequent increase in bone fragility a.
该研究将招募大约350名绝经后骨质疏松症患者,研究的主要终点是12个月时腰椎骨密度(BMD)与基线的百分比变化。次要终点包括额外解剖位置和时间点的BMD百分比变化以及骨转换生化标志物的变化。Angitia于2024年9月27日至30日在加拿大多伦多举行的美国骨与矿物质研究学会2024年年会上首次介绍了AGA2118的人体数据。关于骨质疏松症骨质疏松症是一种全身性骨骼疾病,其特征在于骨量低和骨组织的微结构恶化,从而导致骨脆性增加。