Novartis has released positive data of its monoclonal antibody secukinumab, code named AIN457, from three Phase II trials. The data demonstrated that secukinumab produced a quick and significant improvement of symptoms in patients with moderate-to-severe plaque psoriasis.
Secukinumab (AIN457) is a fully human, targeted monoclonal antibody that specifically binds to and neutralizes interleukin-17A (IL-17A), a cytokine that acts as a potent mediator in delayed – type reactions by increasing chemokine production in various tissues to recruit monocytes and neutrophils to the site of inflammation.
The Swiss pharma major reported the data from three double-blind, parallel group, placebo-controlled Phase II studies, which studied secukinumab in different doses and administration regimens.
In one study, 81% of patients receiving AIN457 150mg subcutaneously once a month experienced at least a 75% improvement of psoriasis signs and symptoms as measured by PASI (Psoriasis Area and Severity Index), as compared to 9% for placebo at week 12. In another study, 83% of patients who were given an intravenous starting dose of AIN457 experienced at least a 75% improvement of symptoms vs 10% for placebo. In the third study, AIN457 in the first month was beneficial to 55% of patients vs 2% for placebo at week 12.
“These data suggest that AIN457 could potentially bring about a considerable improvement in the lives of patients with moderate-to-severe plaque psoriasis by producing a rapid response and substantial relief of symptoms,” said Dr. Kim Papp, Dermatologist and Director of Research at Probity Medical Research, Waterloo, Ontario, Canada, and one of the investigators of the studies. “Plaque psoriasis is a disruptive and often painful chronic immune disease and there is a critical need for new treatment options that combine long-term efficacy with a favorable safety profile.”
“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,” said John Hohneker, Global Head of Development for Integrated Hospital Care at Novartis. “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.”