Angitia Biopharmaceuticals Announces the First Subject Dosed in the Phase Ⅰ trial of AGA2115, a novel biologic for the Treatment of Osteogenesis Imperfecta Woodland Hills, California, USA – 17 Oct 2023 Angitia Biopharmaceuticals, a global clinical-stage biotechnology company focused on the discovery and development of breakthrough therapies that address the unmet medical needs of patients with serious musculoskeletal disease, announced today that the first subject has been successfully dosed in the Phase Ⅰ clinical trial of AGA2115. The First-in-Human (FIH) trial is evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of AGA2115, an investigational therapy for the treatment of osteogenesis imperfecta (OI). The FDA has previously granted AGA2115 an Orphan Drug Designation (ODD) and a Rare Pediatric Disease Designation (RPDD). “Osteogenesis Imperfecta is a devastating genetic disorder that affects the skeleton resulting in bone brittleness and frequent debilitating fractures, and currently has no FDA-approved therapies” said David Ke, M.D., Founder and CEO of Angitia. “Dosing the first patient in our first-in-human study of AGA2115 represents an important milestone for the company, our scientists, and the patients we hope to serve.” ABOUT AGA2115 AND THE PHASE I STUDY AGA2115 is a first-in-class, bispecific antibody being developed for the treatment of osteogenesis imperfecta. The U.S. Food and Drug Administration (FDA) has granted AGA2115 Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD). The Phase 1, first-in-human, randomized, double-blind, placebo-controlled, single and multiple ascending-dose study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AGA2115 in adult healthy volunteers and in adults and adolescents with OI. Visit clinicaltrials.gov (NCT06086613) for more information. ABOUT OSTEOGENESIS IMPERFECTA Osteogenesis imperfecta (OI) is an inherited connective tissue disorder with pathophysiology driven by abnormal collagen metabolism resulting in skeletal deformity, bone fragility, reduced bone mass, and variable extra-skeletal symptoms. OI occurs in approximately 1 in 15,000 births, with between 20,000 to 50,000 affected individuals in the US. As a rare pediatric disease, OI ranges in severity ranging from mild to severe and life-threatening. Disease manifestations occur in the neonatal and pediatric age groups, presenting with frequent and recurrent fractures, often elicited by little or no trauma. Severe OI cases manifest with multiple debilitating fractures resulting in loss of independent ambulation, deformity, and stunted growth, with the most severe cases resulting in perinatal mortality. Associated features may include muscle weakness, joint laxity, issues with dentition, hearing loss, and skeletal malformations.
