Srisakorn/iStock via Getty Images
- Ultragenyx Pharmaceutical (NASDAQ:RARE) and Mereo BioPharma (NASDAQ:MREO) disclosed the secondary endpoint data for sclerostin inhibitor UX143 (setrusumab) from a Phase 2b study in Osteogenesis Imperfecta (OI), an inherited bone disorder.
- The secondary endpoints of the study included HR-pQCT parameters (such as total vBMD) and bone biomarkers.
- New data presented at the American Society for Bone and Mineral Research (ASBMR) 2021 annual meeting indicate that the experimental drug led to a dose-dependent effect of P1NP and CTx serum levels, confirming the mechanism of action of sclerostin inhibition, the companies said.
- P1NP is a marker of bone formation, and CTx is a marker of bone resorption. The biomarker level peaked at month one and declined subsequently, an expected change based on data from previous studies.
- “With Ultragenyx, we plan to advance UX143 into a comprehensive late-stage program in pediatric and adult patients across OI sub-types I, III, and IV,” remarked Mereo CEO Denise Scots-Knight.
- Previously disclosed data from the study had indicated a dose-dependent and statistically significant bone-building effect. The effect detected in several sites of adult OI patients was consistent across all subtypes of the disease investigated.
- As part of its partnership with Ultragenyx (RARE) for setrusumab, Mereo (MREO) is entitled to receive milestone payments worth up to $254 million.