12th May 2014 07:14
LONDON (Alliance News) - AstraZeneca PLC and Amgen Inc said Monday 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.
Using the Psoriasis Area Severity Index to measure the study, primary endpoints were patients achieving at least a 75% improvement from baseline in disease severity at week 12, said AstraZeneca, and patients achieving clear or almost clear skin at week 12 according to the static Physician Global Assessment.
The company said a significantly higher proportion of patients treated with brodalumab achieved a PASI 75 response (primary endpoint), as well as PASI 90 and PASI 100 responses at week 12 (secondary endpoints) compared to a placebo.
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.
The study assessed the safety and efficacy of brodalumab given every two weeks via subcutaneous injection at two doses - 140 milligrams or 210 milligrams - compared to a placebo in patients with moderate-to-severe plaque psoriasis.
"We are encouraged by brodalumab's emerging profile and look forward to presenting the full data in the appropriate scientific forum," said Briggs Morrison, executive vice president of Global Medicines Development at AstraZeneca.
Amgen and AstraZeneca formed a collaboration in April 2012 to jointly develop and commercialise five monoclonal antibodies from Amgen's clinical inflammation portfolio.
Shares in AstraZeneca were trading 0.42% higher at 4,620 pence per share at the market open Monday.
By Alice Attwood; [email protected]; @AliceAtAlliance
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