You may have seen information recently on the Ultragenyx results from the Phase 3 Cosmic or Obit studies for setrusumab. Neither study achieved statistical significance against the primary endpoints of reduction in annualized clinical fracture rate, but both studies did achieve the secondary endpoints of improvements in bone mineral density. Ultragenyx has let us know that they are conducting additional analyses on the data across both studies, including in other bone health and clinical endpoints beyond fractures to more deeply understand the findings.

Ultragenyx does not have a timeline for when the analyses will be complete but patients who are currently receiving setrusumab through the open label extension will remain on drug while analysis is ongoing. Ultragenyx is committed to communicate any future changes and they expect to share an update soon based on their findings. We will do our best to share that information as well.

Above all, we at the OIF, want to extend our heartfelt thanks to the individuals, families, and caregivers who participated in these trials. Your time, commitment, and willingness to take part in research over many years have been invaluable. Because of you, the OI community continues to gain critical insights that help move research forward and inform future approaches.

For all questions about the trial and findings you can reach out directly to Ultragenyx at OIStudyInfo@ultragenyx.com.