09.05.2014 22:18:36

Amgen, AstraZeneca Say Ph 3 Study Of Psoriasis Drug Brodalumab Meets Goals

(RTTNews) - Amgen Inc. (AMGN) and AstraZeneca PLC (AZN, AZN.L) said Friday that the Phase 3 AMAGINE-1 study evaluating brodalumab in patients with moderate-to-severe plaque psoriasis met all primary and secondary endpoints for both evaluated doses.

Brodalumab is the only investigational treatment in development that binds to the interleukin-17 receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 ligands to the receptor.

Primary endpoints were patients achieving at least a 75% improvement from baseline in disease severity at week 12, as measured by the Psoriasis Area Severity Index, and patients achieving clear or almost clear skin at week 12 according to the static Physician Global Assessment.

Psoriasis is a non-contagious chronic disease in which the immune system causes skin cells to grow at an accelerated rate. Instead of being shed, skin cells pile up, causing painful and itchy, red, scaly patches.

AMAGINE-1 is one of three Phase 3 studies designed to assess the efficacy and safety of brodalumab in patients with moderate-to-severe plaque psoriasis. AMAGINE-2 and AMAGINE-3 are designed to evaluate the efficacy and safety of induction and maintenance regimens of brodalumab at different dose schedules in patients with moderate-to-severe plaque psoriasis compared to ustekinumab and placebo.

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