Ultragenyx Announces Completion of Enrollment in Phase 3 Orbit and Cosmic Studies Evaluating Setrusumab (UX143) for the Treatment of Osteogenesis Imperfecta (OI)
Ultragenyx Pharmaceutical Inc. (RARE)
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Source: GlobeNewswire
NOVATO, Calif., April 30, 2024 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that all patients have been enrolled across the Phase 3 Orbit and Cosmic studies evaluating setrusumab (UX143) in pediatric and young adult patients with osteogenesis imperfecta (OI). The pivotal Phase 3 portion of the Orbit study has randomized 158 patients ages 5 to 25 years, and the Cosmic study has completed enrollment of 66 patients ages 2 to “We would like to thank the OI community for its support, trust and participation as we complete this important step in the advancement of the setrusumab program,” said Eric Crombez, M.D., chief medical officer at Ultragenyx. “The interim Phase 2 Orbit study results show a rapid and clinically meaningful decrease in fracture rate, giving us confidence in our ability to bring this potential new treatment to patients living with OI. Our goal is to provide patients and their families a novel treatment that can significantly red
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