Biotechnology major Amgen says that data from a Phase II study of its antibody denosumab shows that it has potential as a treatment for post-menopausal osteoporosis.
The results, which were presented at the American Society for Bone and Mineral Research's annual meeting in Philadelphia, suggest that targeting proteins involved in the regulation of bone destruction and formation may represent an
effective treatment approach for osteoporosis and other bone disorders.
Densomab is a fully-human monoclonal antibody that targets the RANK ligand, a key mediator of the function of osteoclasts cells involved in the re-absorption of bone.
In the trial, patients who received 60mg of the agent, administered twice a year via subcutaneous injection, experienced a 6.7% increase in bone mineral density when compared with the placebo group, who saw a 0.3% decline from baseline levels over the course of the 24-week study.
In addition to three Phase III and two Phase II trials in postmenopausal osteoporosis, Amgen is conducting a Phase II trial of denosumab in the treatment of bone erosions in rheumatoid arthritis, as well as four Phase III and two Phase II studies in advanced cancer patients with, or at risk for, bone metastases. A Phase II study is also evaluating the antibody as a possible treatment for multiple myeloma.
- Meanwhile, Amgen also reported data from animal studies of a sclerostin-neutralising antibody that it is developing with Belgian biopharmaceutical company UCB at the ASBMR. The programme showed that primates receiving a 30mg/kg dose of the drug achieved a 5.5-fold increase in the rate of bone formation.