Date: 2013-02-11
Type of
information: Halting of the trial
phase: 3
Announcement: halting of the trial
Company: UCB (Belgium) Amgen (USA - CA)
Product: romosozumab (CDP7851/AMG 785)
Action
mechanism:
- monoclonal antibody. sclerostin antibody (CDP7851/AMG 785) is a humanized monoclonal antibody that binds to and inhibits sclerostin, a protein secreted by bone cells that inhibits bone formation. By binding to and blocking sclerostin, it is designed to increase the amount of bone in the skeleton.
Disease: acceleration of fracture healing
Therapeutic
area: Bone diseases
Country:
Trial
details:
- UCB and its partner, Amgen, have decided to not pursue a phase 3 clinical trial program for CDP7851/AMG785 (romosozumab) in acceleration of fracture healing based on the evaluation of currently available Phase 2 results from accelerated fracture healing studies and general regulatory guidance on fracture healing programs. However, the safety profile of this program remains consistent with what has been seen in the post-menopausal osteoporosis program and is not a factor in this decision to not pursue acceleration of fracture healing. Complete phase 2 accelerated fracture healing results will be presented at a future conference. The decision to no longer pursue a phase 3 program for accelerated fracture healing has no impact on UCB's 2012 financials.
Last year, the two partners had also initiated a phase 3 clinical trial program for the treatment of postmenopausal osteoporosis. Amgen and UCB have announced that they will continue this on-going phase 3 program.
Latest
news:
Is
general: Yes
