AstraZeneca, Amgen Trumpet Positive Phase 3 Results For Brodalumab

AstraZeneca and its partner Amgen announced positive results from the second pivotal Phase 3 trial of brodalumab in moderate-to-severe plaque psoriasis.

Brodalumab (AMG 827) is a human monoclonal antibody (mAb) designed to bind to the interleukin-17A (IL-17A) receptor to keep IL-17 ligands from binding to their receptor, in turn halting inflammatory signaling. The IL-17 pathway is considered crucial to the triggering and development of plaque psoriasis. Amgen and AstraZeneca first signed a deal to co-develop and market five monoclonal antibodies including brodalumab back in April 2012. Aside from moderate-to-severe plaque psoriasis, the drug is being investigated in a Phase 3 study for psoriatic arthritis and a Phase 2 trial for asthma.

The pivotal Phase 3 trial AMAGINE-3TM assessed two doses of brodalumab against ustekinumab (brand name Stelara) and placebo in over 1,800 patients with moderate-to-severe plaque psoriasis. Brodalumab met the trial’s primary endpoint of superiority to Stelara in achieving total skin clearance. More patients who were treated with brodalumab also experienced clear or almost clear skin at week 12 compared to placebo. Brodalumab also met all secondary endpoints of the trial.

Briggs W. Morrison, EVP of Global Medicines Development at AstraZeneca, said, “These results add to the growing body of evidence supporting the potential value that brodalumab may bring to the treatment of psoriasis by targeting the IL-17 receptor. We look forward to sharing results later this year from AMAGINE-2TM, our remaining head-to-head study evaluating brodalumab versus Stelara.”

Psoriasis is a chronic and serious inflammatory disease characterized by red, scaly patches raised on the skin. These may be found on the outside of the elbows, knees, or scalp. Psoriasis affects an estimated 125 million people around the world, 80 percent of which have plaque psoriasis.

Sean E. Harper, EVP of Research and Development at Amgen, said, “Despite a variety of treatment options available for psoriasis, many patients still do not meet skin clearance goals. These results are of particular importance as they are the first to demonstrate superiority to Stelara in achieving total skin clearance, and the second positive pivotal Phase 3 study evaluating brodalumab in patients with moderate-to-severe plaque psoriasis.”

The company said it will present detailed results of the AMAGINE-3 trial at the appropriate scientific forum in the future.