AstraZeneca and Amgen have reported positive results from the multi-arm Phase III AMAGINE-2 trial of brodalumab in patients with moderate-to-severe plaque psoriasis.
The trial evaluated the safety and efficacy of brodalumab given at two doses every two weeks through subcutaneous injection compared with Stelara and placebo in these patients.
More than 1,800 patients with moderate-to-severe plaque psoriasis were included in the trial that met its primary endpoints, the company said. All key secondary endpoints comparing brodalumab with placebo were also met.
Results showed that the primary endpoint comparing 210mg of brodalumab as well as a pre-specified weight-based analysis group with Stelara was the proportion of patients achieving total clearance of skin disease, as measured by Psoriasis Area Severity Index (PASI 100) at week 12.
When compared with placebo, significant proportion of patients treated with brodalumab achieved at least a 75% improvement from baseline in disease severity (PASI 75) at week 12, and it has also achieved clear or almost clear skin, according to the sPGA (0 or 1)at week 12.
Amgen Research and Development executive vice-president Sean Harper said: "Results from AMAGINE-2 underscore that treatment with brodalumab could help a significant number of moderate-to-severe plaque psoriasis patients achieve total clearance of their skin disease, and the great majority achieve at least a 75% improvement in their disease.
"AMAGINE-2 is the third and final pivotal study in our Phase III psoriasis programme and the robust data from these studies will form the basis of our global filing plan. We look forward to discussions with regulatory authorities."
During the trial’s 12-week, double-blind, active comparator- and placebo-controlled induction phase, patients were randomised in a 2:2:1:1 ratio to receive brodalumab (210mg or 140mg), Stelara (per the labeled dose), or placebo.
According to the company, brodalumab is the only investigational treatment in development that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signalling by blocking the binding of several IL-17 cytokines (A, F and A/F) to the receptor.
The AMAGINE programme includes three Phase III trials designed to evaluate the efficacy and safety of brodalumab in patients with moderate-to-severe plaque psoriasis.
The two firms have collaborated in 2012 to jointly develop and commercialise five monoclonal antibodies from Amgen’s clinical inflammation portfolio.