Amgen, AstraZeneca Report Phase 3 Brodalumab Meets Endpoints In Psoriasis
By Cyndi Root
Amgen and AstraZeneca report that a Phase 3 trial of brodalumab has met its primary endpoint and all secondary endpoints in the treatment of moderate-to-severe plaque psoriasis. The two companies announced the results in a press release, stating that the AMAGINE-3 study compared brodalumab to Stelara (ustekinumab) and placebo. Amgen and AstraZeneca are conducting studies of five of Amgen’s monoclonal antibodies, including brodalumab, under a collaboration agreement initiated in April 2012.
Sean E. Harper, M.D., executive VP of Research and Development at Amgen, said, “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."
Brodalumab
Brodalumab (AMG 827) is a human monoclonal antibody that dampens inflammatory signals by blocking IL-17 ligand binding to the receptor. Influencing the IL-17 pathway and stopping IL-17 ligand binding reduces inflammatory signals, thereby reducing psoriasis. Amgen is also investigating brodalumab for psoriatic arthritis in Phase 3 trials and in Phase 2 asthma trials.
Brodalumab Study
The AMAGINE-3 study compared two doses of brodalumab to Stelara and a placebo in 1,800 patients with moderate-to-severe plaque psoriasis. The study showed that brodalumab was superior to Stelara in achieving total clearance of skin disease, as measured by the Psoriasis Area Severity Index, thereby meeting the trial’s primary endpoint. Compared to the placebo, brodalumab patients achieved at least a 75 percent improvement from baseline in disease severity at week 12 and clear or almost clear skin. The 210 mg brodalumab group fared better than the 140 mg group, as 36.7 percent achieved skin clearance compared to 27 percent. Both the 210 and 140 mg brodalumab doses proved superior to Stelara patients, as only 18.5 percent achieved skin clearance.
Dr. Harper said, "Despite a variety of treatment options available for psoriasis, many patients still do not meet skin clearance goals.” Amgen and AstraZeneca state that they will share results later in the year on the AMAGINE-2 trial evaluating brodalumab versus Stelara.
Stelara
Stelara is a Johnson & Johnson Drug, manufactured by J & J’s subsidiary Centocor Ortho Biotech of Horsham, PA. The Food and Drug Administration (FDA) approved Stelara (ustekinumab) in 2009 for moderate to severe psoriasis. Stelara is a monoclonal antibody, a biological treatment that mimics the body’s antibodies and blocks two proteins that cause inflammation.