Novartis announced results from three Phase 2 trials evaluating AIN457 in patients with moderate-to-severe plaque psoriasis. The three double-blind, parallel group, placebo-controlled Phase 2 studies were designed to evaluate the safety and efficacy of AIN457 in different doses and administration regimens. The primary endpoints of the studies were PASI 75 responses at Week 12, with PASI 90 responses at Week 12 among the secondary endpoints. The primary endpoint was met for one or more of the doses (25mg, 75mg and 150mg, subcutaneously; 3mg/kg, 10mg/kg and 3x10mg/kg, intravenously) and regimens (Early, Monthly and Single) studied in each trial. In all three studies, 60% of patients experienced adverse events with AIN457 in the first 12 weeks compared to 61% with placebo.
AIN457 is a fully human monoclonal antibody neutralizing interleukin-17A, a key pro-inflammatory cytokine. Phase II studies in moderate-to-severe plaque psoriasis and arthritides (rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis) have suggested that AIN457 may provide a new mechanism of action for the treatment of immune-mediated diseases.
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