Amgen, AstraZeneca's experimental psoriasis drug brodalumab meets key endpoints of Phase III study

Amgen and AstraZeneca announced Friday that the experimental psoriasis therapy brodalumab met all primary and secondary endpoints in a Phase III study of patients with moderate-to-severe psoriasis. Results of the AMAGINE-1 study showed that the drug, which blocks ligand binding to the interleukin-17 receptor, was associated with a significant proportion of patients achieving at least a 75 percent improvement from baseline in disease severity, and the number of patients displaying clear or almost clear skin at week 12 versus placebo. Briggs W. Morrison, executive vice president of global medicines development at AstraZeneca, said "we are encouraged by brodalumab's emerging profile and look forward to presenting the full data in the appropriate scientific forum."

The trial randomised 661 patients with moderate-to-severe psoriasis to receive one of two doses of brodalumab or placebo every two weeks. After 12 weeks, patients who achieved clear or almost clear skin as determined by the static Physician Global Assessment were re-randomised to continue treatment with the therapy or placebo, while those who did not respond to therapy or were randomised to the placebo group were treated with the highest dose of brodalumab.

Results showed that 83.3 percent of patients being administered the highest dose of brodalumab and 60.3 percent of patients in the lower-dose group experienced at least a 75 percent reduction in improvement from baseline in disease severity at week 12, as measured by the Psoriasis Area Severity Index (PASI 75), versus 2.7 percent for the placebo group. Meanwhile, 70.3 percent of patients in the highest-dose group of the therapy and 42.5 percent of patients in the lower-dose group exhibited PASI 90 responses, compared to 0.9 percent of placebo-treated patients, while 41.9 percent and 23.3 percent of patients in the highest and lower-dose groups, respectively, achieved PASI 100 responses, versus 0.5 percent for the placebo group.

Brodalumab is one of five monoclonal antibodies from Amgen's clinical inflammation portfolio that Amgen and AstraZeneca are co-developing under a 2012
partnership. Sean E. Harper, executive vice president of R&D at Amgen, noted "this is the first read-out from our Phase 3 psoriasis clinical programme and we look forward to obtaining additional Phase 3 data from our two head-to-head studies", which are comparing brodalumab with Johnson & Johnson's Stelara (ustekinumab)‎ and are anticipated later this year.

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