Mereo BioPharma Reports P-III (ORBIT & COSMIC) Trials Findings on Setrusumab in Osteogenesis Imperfecta
Shots:
- Mereo BioPharma has reported setrusumab (UX143) results from the global P-III (ORBIT) trial vs PBO & P-III (COSMIC) trial vs bisphosphonates (IV) in 159 pts (5-25yrs.) & 69 pts (2 to <7 yrs.), respectively, with osteogenesis imperfecta
- Neither study met its 1EP of reduced annualized clinical fracture rate, but both showed statistically significant improvements in their 2EPs of improved bone mineral density (BMD)
- In ORBIT, setrusumab significantly improved BMD without reducing fracture rates amid low PBO fractures, while in COSMIC, BMD gains correlated with lower fractures but did not meet significance; further analyses are ongoing
Ref: Globenewswire | Image: Mereo BioPharma | Press Release
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