Two phase III studies of setrusumab, Orbit and Cosmic, for treating brittle bones have failed and left the developers floundering on Wall Street. Neither of Ultragenyx Pharmaceutical Inc. and Mereo Biopharma Group plc’s studies of the monoclonal antibody in treating osteogenesis imperfecta hit statistical significance in their primary endpoints, though they did achieve their secondary endpoints. The companies are still looking at the numbers to determine their next steps.
Nextcure Inc. has unveiled new preclinical data supporting the therapeutic potential of NC-605, a new anti-Siglec-15 antibody, in treating osteogenesis imperfecta, a rare genetic disorder characterized by fragile bones and frequent fractures.
Ultragenyx Pharmaceutical Inc. and Mereo Biopharma Group plc, along with investors, had hoped for an early halt to the phase III study of setrusumab in treating brittle bones. They didn’t get it, as the clinical trial’s data monitoring committee wants the study to roll on through its final analysis.
Osteogenesis imperfecta (OI) is characterized by low bone mass, with increased risk of bone fracture due to mutations in certain genes encoding type I collagen, such as COL1A1 and COL1A2.
Angitia Biopharmaceuticals raised $46 million in a series B round extension, bringing the total raised under the series B to $170 million led by Morningside Group and will enable the company to advance its pipeline of musculoskeletal therapies.
Angitia Biopharmaceuticals raised $46 million in a series B round extension, bringing the total raised under the series B to $170 million led by Morningside Group and will enable the company to advance its pipeline of musculoskeletal therapies.
Quince Therapeutics Inc. (formerly Novosteo Inc.) has presented data on NOV-004, a construct that delivers abaloparatide therapeutic agent into the fracture site, designed for the treatment of osteogenesis imperfecta.
Pediatric orthopedics company Orthopediatrics Corp. has signed a $33 million deal to buy competitor Pega Medical Inc. As part of the deal, Orthopediatrics will acquire Pega’s Fassier-Duval telescopic intramedullary system. The implant is designed to treat bone deformities in children with osteogenesis imperfecta. Orthopediatrics will pay a $31 million upfront cash payment plus $2 million in stock – which includes certain restrictions for three years.
Mereo Biopharma plc is heading into phase III with a bone-building drug to treat the rare condition osteogenesis imperfecta – and CEO Denise Scots-Knight reckons the company has the financial backing to get setrusumab marketed thanks to a partnership with Ultragenyx Pharmaceutical Inc.