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Mereo BioPharma Group plc (NASDAQ:MREO) and Ultragenyx Pharmaceutical (NASDAQ:RARE) Inc. announced that the randomized, placebo-controlled Phase 3 portion of the Orbit study evaluating UX143 (setrusumab) in pediatric and young adult patients with osteogenesis imperfecta is proceeding as planned, with a final analysis expected around the end of the year.
According to a press release statement included in a recent SEC filing, the Data Monitoring Committee met and informed Ultragenyx that UX143 demonstrates an acceptable safety profile. The committee recommended that Ultragenyx and Mereo continue the study to the final analysis.
The filing also noted that, consistent with the statistical analysis plan, data from the UX143 Cosmic study were not analyzed at this interim timepoint. The conduct of the study is ongoing, and safety in the younger patient population is reported to be consistent with the safety profile observed in other studies.
Patients are expected to continue dosing in the ongoing Phase 3 Orbit and Cosmic clinical studies. Final analyses will be conducted after patients have been on therapy for at least 18 months. The threshold for statistical significance for the Phase 3 Orbit final analysis is set at p<0.04, and for the Phase 3 Cosmic final analysis at p<0.05.
This information is based on a press release statement included in a Form 8-K filed with the Securities and Exchange Commission.
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