Ultragenyx Pharmaceutical Inc., along with Mereo BioPharma Group plc, has announced the progression of the UX143 (setrusumab) Phase 3 Orbit study for treating osteogenesis imperfecta in pediatric and young adult patients. This randomized, placebo-controlled study is moving toward a final analysis, expected around the end of the year. The Data Monitoring Committee has confirmed that UX143 has an acceptable safety profile, allowing the study to continue as planned. The results from this study, along with the Cosmic study, are anticipated to be available by year-end. The ongoing clinical trials will conduct final analyses after patients have received therapy for at least 18 months, with statistical thresholds set at p<0.04 for Orbit and p<0.05 for Cosmic.
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