Novartis Announces Secukinumab's High Efficacy Against Psoriasis

Novartis reported positive results from pivotal Phase III studies showing that secukinumab (AIN457) demonstrated consistent and high efficacy against psoriases when administered with a pre-filled syringe (PFS) or autoinjector/pen (AI). The data was being presented for the first time at the 72 Annual Meeting of the American Academy of Dermatology (AAD) in Denver, USA.

Tim Wright, Global Head of Development for Novartis Pharmaceuticals, said “It is important that people living with psoriasis, a chronic skin disease, have highly effective and safe treatments they can conveniently self-administer. These exciting results from our specialty dermatology portfolio show that secukinumab, the first IL-17A inhibitor with regulatory submissions completed, had similar efficacy in clearing skin with a convenient pre-filled syringe and autoinjector pen as in the landmark FIXTURE study, where it was significantly superior to Enbrel, a biologic psoriasis therapy approved 10 years ago.”

FEATURE and JUNCTURE studies are the first Phase III trials evaluating secukinumab in clearing patients’ skin with PFS and AI administration, allowing self administration anywhere. The studies met all primary and pre-specified secondary endpoints.

“Across the co-primary endpoints in both studies, secukinumab 300 mg demonstrated significant improvements in PASI 75 at Week 12 versus placebo… and was also superior to placebo according to the Investigator's Global Assessment (IGA mod 2011). Patients also benefitted from rapid and significant skin clearance with secukinumab in both studie. Already by Week 3, patients taking secukinumab 300 mg experienced superior efficacy in clearing skin compared to placebo,” reported Novartis in its press release.

Secukinumab is a fully human monoclonal antibody designed to selectively bind to and neutralize interleukin-17A. IL-17A is a central cytokine implicated in the development of psoriasis and found in high concentrations in skin affected by the disease. The protein plays a crucial role in autoimmune response disorders such as moderate to severe plaque psoriasis.

The company says secukinumab is the first therapy selectively targeting IL-17A with Phase III results. Submissions for regulatory approval for the drug in the EU and U.S. were filed in 2013.