setrusumab

Home
Ligands
setrusumab

GtoPdb Ligand ID: 9202

Synonyms: BPS 804 | BPS804 | UX-143 | UX143

Comment: Setrusumab (BPS-804) is a fully human investigational monoclonal antibody targeting sclerostin (SOST; which is a negative regulator of bone formation), that is intended to improve bone density.
Development of anti-sclerostin antibodies by Novartis is claimed in patent WO2009047356 [2], although we cannot definitively conclude that BPS-804 is claimed within that patent application.
The potential of sclerostin as a therapeutic target in bone diseases is reviewed by Lewiecki (2014) [3].

No information available.

No information available.

Summary of Clinical Use
BPS-804 has completed Phase 2 clinical trial in patients with osteogenesis imperfecta, a.k.a. brittle bone syndrome (NCT01417091). Development for hypophosphatasia and postmenopausal osteoporosis has been discontinued. The agent has both U.S. and EU orphan drug designation for osteogenesis imperfecta.

Summary of Clinical Use

BPS-804 has completed Phase 2 clinical trial in patients with osteogenesis imperfecta, a.k.a. brittle bone syndrome (NCT01417091). Development for hypophosphatasia and postmenopausal osteoporosis has been discontinued. The agent has both U.S. and EU orphan drug designation for osteogenesis imperfecta.

Mechanism Of Action and Pharmacodynamic Effects
BPS-804 binds to sclerostin, an osteocyte protein which normally inhibits Wnt signalling and decreases bone formation by osteoblasts [1,5] as part of the regulatory system controlling bone mass equilibrium. Neutralisation of sclerostin activity leads to improved bone formation in animal models, as reported for another anti-sclerostin antibody, romosozumab [4,6].

Mechanism Of Action and Pharmacodynamic Effects

BPS-804 binds to sclerostin, an osteocyte protein which normally inhibits Wnt signalling and decreases bone formation by osteoblasts [1,5] as part of the regulatory system controlling bone mass equilibrium. Neutralisation of sclerostin activity leads to improved bone formation in animal models, as reported for another anti-sclerostin antibody, romosozumab [4,6].

Clinical Trials
Clinical Trial ID	Title	Type	Source	Comment	References
NCT01417091	Safety, Pharmacokinetics and Pharmacodynamics of BPS804 in Osteogenesis Imperfecta	Phase 2 Interventional	Novartis
NCT03118570	A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804	Phase 2 Interventional	Ultragenyx Pharmaceutical Inc
NCT05125809	Study to Assess Dose, Efficacy and Safety of Setrusumab in Participants With Osteogenesis Imperfecta	Phase 2/Phase 3 Interventional	Ultragenyx Pharmaceutical Inc
NCT05768854	Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta	Phase 3 Interventional	Ultragenyx Pharmaceutical Inc