Amgen's Brodalumab Hits Phase 2 Primary Endpoint
Amgen reported that its Phase II trial investigating brodalumab as treatment for psoriatic arthritis met its primary endpoint and improved clinical signs and symptoms.
Brodalumab (AMG 827) is a novel human monoclonal antibody that inhibits inflammatory signaling by blocking the binding of a number of interleukin-17 (IL-17) ligands to their receptors. Through its mechanism of action, the drug interferes with signals that may lead to inflammation characterizing psoriatic arthritis.
Sean E. Harper, EVP of Research and Development at Amgen, said that the company developed the clinical program for brodalumab across a spectrum of inflammatory diseases including psoriasis, psoriatic arthritis, and asthma based on data illustrating IL-17 receptors’ role in the disease. “These encouraging psoriatic arthritis data showing that patients not only experienced improvements in clinical symptoms at week 12, but that those improvements continued over time and were sustained, were the basis for our decision to continue development of this molecule as a potential treatment for the many people who are looking to better control their disease.”
The drug demonstrated superiority over placebo in improving tender and swollen joints as well as patient and physician evaluations of disease activity, including pain, disability and inflammatory markers in the randomized, placebo-controlled, and double-blind Phase II trial.
Philip Mease, lead investigator and study author, at the Swedish Medical Center and University of Washington, said, “We're encouraged that treatment with brodalumab significantly reduced clinical signs and joint symptoms, compared to placebo, and that similar degrees of disease improvement were seen in biologic-treated and biologic-naive patients with psoriatic arthritis. These results add to the growing body of evidence indicating that the IL-17 receptor is a promising target for the treatment of inflammatory diseases, including psoriatic arthritis.”
A Phase III program is underway for further investigation of the drug as potential treatment for psoriatic arthritis.