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.
Ultragenyx Data De-Risk Phase III Trial Of Setrusumab
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.
More from Clinical Trials
• By
RemeGen is planning to complete enrolment in the global Phase III RemeMG study with telitacicept in generalized myasthenia gravis by the end of 2025 or early 2026. The Chinese firm has already sidelined two other global Phase III trials with the molecule to prioritize the indication.
• By
The biotech is banking on itolizumab’s longer-term efficacy as well as unmet need in frontline acute graft-versus-host disease as it prepares to meet with the FDA.
• By
The head of the Spanish medical dermatology specialist told Scrip that maintaining the status quo will only result in the continent’s life sciences sector slipping further behind the US and China.
• By
With its exon 53-skipping candidate already showing promise in 24-week data, Wave now has 48-week data showing improvements in muscle health and functional outcomes.
More from R&D
• By
The Danish firm is spending nearly $580m to repurchase up to 2.2 million shares
• By
The Texas-based firm is giving up on the investigational Alzheimer’s therapy after a second Phase III failure left it with nowhere to go in the disease.
• By
A decision from the FDA is due by 28 September.