At the annual European Academy of Dermatology and Venereology (EADV) Congress in Lisbon, Portugal, Novartis announced positive results from its three Phase II trials of AIN457 (secukinumab), a drug designed for the treatment of psoriasis. The results revealed quick and significant improvements of symptoms in patients with moderate-to-severe plaque psoriasis.

About 2% of people worldwide suffer from plaque psoriasis, with 30% of patients being affected moderately to severely by the disease, which is a common hereditary and immune-mediated systemic disorder that is characterized by skin lesions (plaques). The skin lesions linked to plaque psoriasis are associated with significant symptoms, including itching, scaling and pain, which can have a severe impact on those who suffer from chronic plaque psoriasis, as it ultimately influences a patient’s emotional, social, physical and occupational functioning. These implications on a patient’s reduced health related quality of life are comparable with those of arthritis, diabetes, hypertension, heart disease and depression.

AIN457 is a fully human, targeted monoclonal antibody. It specifically and quickly binds to and neutralizes interleukin-17A (IL-17A), a key-inflammatory cytokine that is associated with a number of immune-mediated diseases, such as psoriasis. Phase II studies in moderate-to-severe plaque psoriasis and arthritides (rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis) sufferers have indicated that AIN457 could provide a potential new treatment strategy for immune-mediated diseases. The Phase III study is currently undergoing.

Researchers conducted three double blind, parallel group, placebo-controlled Phase II studies to assess the safety and efficacy of AIN457 in different dosages and administration regimens. Improvements were measured against the PASI Index (Psoriasis Area and Severity Index) with the primary endpoints set at PASI 75 responses at Week 12, with PASI 90 responses at Week 12 as one of the secondary endpoints. The findings revealed that the primary endpoint was met for one or more of the doses (25, 75 and 150 mg, subcutaneously; 3 mg/kg, 10mg/kg and 3x10mg/kg, intravenously) and regimens (Early, Monthly and Single) studied in each trial. In comparison to 61% of participants in the placebo group, 60% of patients in all three studies experienced adverse events with AIN457 in the first twelve weeks, with serious adverse events being reported in 3% of AIN457 patients compared with 1% in the placebo group.

One study revealed that 81% of patients who received 150 mg of AIN457 subcutaneously once monthly showed an improvement of psoriasis signs and symptoms of at least 75% compared with 9% on placebo at week 12 (p

John Hohneker, Global Head of Development for Integrated Hospital Care at Novartis stated:

“We are encouraged by these positive Phase II results and look forward to receiving the results of larger-scale and longer-term Phase III studies with AIN457 which began this year. Novartis is committed to providing new treatment options for patients with moderate-to-severe plaque psoriasis, who face significant daily physical discomfort as well as the serious psychological impact of living with this disease.”

Written by Petra Rattue