Novartis' Secukinumab Hits Targets In 2 Phase 3 Studies

Novartis reported that AIN457 (secukinumab) met both the primary and secondary endpoints in two pivotal Phase 3 trials in patients with adult onset psoriatic arthritis (PsA).

Secukinumab is a fully human monoclonal antibody designed to selectively inhibit the activity of IL-17A, a protein that triggers inflammatory disease such as arthritic diseases. IL-17A is also at the root of the development of psoriasis. The drug is undergoing separate clinical trials aside from PsA for the treatment of ankylosing spondylitis (AS) and rheumatoid arthritis (RA).

Psoriatic arthritis is a long lasting and complex condition that features joint inflammation often in combination with psoriasis. The disease results in irreversible joint damage in many patients and leads to significant disability, reduced life expectancy, and poor quality of life.

In the two Phase 3 trials, FUTURE 1 and FUTURE 2, secukinumab demonstrated efficacy compared to placebo. Primary endpoints included improvement of signs and symptoms of PsA, including peripheral joint disease and prevention of joint damage. The drug also delivered clear or almost clear skin.

Vasant Narasimhan, Global Head of Development at Novartis Pharmaceuticals, said, “Building on the positive data previously reported in psoriasis, we are excited to present the first Phase 3 results of secukinumab in PsA. These positive results are planned to form the basis of a filing application to regulatory authorities in this indication. Effective new therapies are urgently needed for newly PsA diagnosed patients and for nearly half of PsA patients who are dissatisfied with or not responding to their current treatments.”

Novartis said it plans to file regulatory approval for secukinumab in PsA in the U.S. and EU in 2015. This will follow the company’s global regulatory applications in 2013 for the drug as a treatment for moderate-to-severe plaque psoriasis. This July, Novartis published positive results for secukinumab against Pfizer’s Enbrel in the treatment for plaque psoriasis.