Phase II/III Orbit study shows benefit of setrusumab in osteogenesis imperfecta

Shares of US firm Ultragenyx Pharmaceutical (Nasdaq: RARE) and UK-based Mereo BioPharma (Nasdaq: MREO) rose in pre-market activity, up 6.5% to $54.48 and 11.4% at $1.17, respectively, after the companies released new showing that setrusumab rapidly induced bone production in osteogenesis imperfecta (OI)-affected patients.

Across all patients evaluated, as of the data cut off, setrusumab demonstrated statistically-significant increases in levels of serum P1NP, a sensitive marker of bone formation, and a substantial and significant improvement in bone mineral density (BMD) by three months.

Originally a Novartis (NOVN: VX), Mereo acquired rights to setrusumab in 2015, and in 2020 entered into a license collaboration with Ultragenyx that could be worth around $300 million. The US Food and Drug Administration granted the coveted Rare Pediatric Disease designation (RPDD) for setrusumab the same year.