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AGA2115 is a first-in-class, humanized bispecific antibody developed by Angitia Biopharmaceuticals for the treatment of osteogenesis imperfecta (OI), a rare and life-threatening genetic skeletal disorder. The drug works by simultaneously neutralizing two key negative regulators of bone formation, sclerostin (SOST) and Dickkopf-related protein 1 (DKK1), thereby increasing bone mass, improving bone strength and structure, and reducing skeletal fractures. Preclinical studies have demonstrated robust efficacy in restoring bone quality in disease models. The U.S. FDA has granted Orphan Drug Designation and Rare Pediatric Disease Designation to AGA2115 for OI. It is currently being evaluated in Phase 1 clinical trials[1][2][3][4][6][7].
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