Ultragenyx, Mereo BioPharma receive DMC recommendation to continue Orbit study

Ultragenyx (RARE) and Mereo BioPharma (MREO) announced that the randomized, placebo-controlled Phase 3 portion of the Orbit study evaluating UX143 in pediatric and young adult patients with osteogenesis imperfecta is progressing toward a final analysis consistent with the original plan, around the end of the year. The Data Monitoring Committee met and informed the company that UX143 demonstrates an acceptable safety profile and the company should continue the study to the final analysis. Consistent with the statistical analysis plan, data from the Cosmic study were not analyzed at this interim timepoint. Study conduct is going well and safety in this younger patient population is consistent with the safety profile in the other studies. Patients will continue dosing in the ongoing Phase 3 Orbit and Cosmic clinical studies with the final analyses to be conducted after patients have been on therapy for at least 18-months.