Ultragenyx Pharmaceutical Inc. has announced that the first patients have been dosed in its Phase 3 clinical trials evaluating setrusumab for the treatment of Osteogenesis Imperfecta (OI). The Phase 3 portion of the Orbit study is enrolling approximately 195 pediatric and young adult patients, while the newly initiated Cosmic study is enrolling approximately 65 younger pediatric patients. Setrusumab is a monoclonal antibody that inhibits sclerostin, a protein that affects bone formation and strength. The trials aim to evaluate the effect of setrusumab compared to placebo or intravenous bisphosphonate therapy on fracture rates in different age groups.
Osteogenesis Imperfecta (OI) is a group of genetic disorders that affect bone metabolism, leading to increased bone fragility and fractures. Currently, there are no approved treatments for OI. Ultragenyx's Phase 3 program aims to assess the clinical potential of setrusumab in improving therapeutic outcomes for OI patients.
Ultragenyx Pharmaceutical Inc. has recently initiated Phase 3 clinical trials