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Ultragenyx Data De-Risk Phase III Trial Of Setrusumab

 
• By Joseph Haas

The Mereo-partnered drug is in pivotal development for osteogenesis imperfecta. Ultragenyx also recently reported positive Phase III data for a rare disease gene therapy.

Bone health
Ultragenyx's 14-month data for setrusumab shows sustained reduction of fractures • Source: Shutterstock

Ultragenyx Pharmaceutical Inc. unveiled positive 14-month data on 11 June from the Phase II portion of a potentially registrational trial of setrusumab in osteogenesis imperfecta (OI), which multiple analysts said will de-risk the drug’s chances of succeeding in the trial’s Phase III portion. Interim Phase III readouts for the drug, partnered with UK-based Mereo BioPharma Group plc, are expected in late 2024 or early-to-mid 2025.

Key Takeaways

  • Ultragenyx updated six-month data for its osteogenesis imperfecta candidate setrusumab with 14-month data from a Phase II/III study that demonstrated sustained reduction in annualized fracture rate.

It was the second positive data readout for Ultragenyx in the past two weeks, following the 30 May disclosure of...

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