Novartis Posts Phase 3 Results For Secukinumab In AS

Novartis reported positive results from two pivotal Phase 3 studies of secukinumab AIN457) investigating the drug in ankylosing spondylitis (AS).

Secukinumab is a human monoclonal antibody (mAb) designed to selectively neutralize interleukin-17A (IL-17A), a cytokine that plays a part in immune responses and inflammatory arthritic diseases. Aside from AS, the drug is also undergoing clinical development as a treatment for psoriatic arthritis (PsA) and rheumatoid arthritis (RA).

The drug met the primary endpoint in the multicenter, placebo controlled, randomized Phase 3 studies showing that the drug improved disease signs and symptoms compared to placebo. Over 60 percent of patients achieved an ASAS20 response, used as a standard tool to measure clinical improvement.

Ankylosing spondylitis (AS) is a spondyloarthritis (SpA) disease type that belongs to a family of long term inflammatory diseases. As much as 40 percent of patients with AS are unable to respond adequately or at all to standard of care anti-TNF (tumor-necrosis-factor) treatment, while secukinumab is the first non-anti TNF biologic to demonstrate efficacy in AS patients. Secukinumab is the first selective IL-17A inhibitor to show superiority over placebo in Phase 3 trials in AS.

Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals, said, “We are proud to present positive Phase 3 results of secukinumab in ankylosing spondylitis, which marks a potential new treatment option for these patients. These ground-breaking data are expected to form the basis of joint regulatory submissions planned for 2015, which also includes results from the FUTURE 1 and FUTURE 2 psoriatic arthritis studies.”

The company said it will present the results at a plenary session and poster presentation at the upcoming American College of Rheumatology (ACR) Congress in Boston.

Last month, Novartis also said that it has been backed by the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the U.S. Food and Drug Administration (FDA) for the regulatory approval of secukinumab for the treatment of moderate-to-severe plaque psoriasis. The company also plans to submit regulatory filings for secukinumab in AS and psoriatic arthritis in 2015.