News Feature | October 28, 2014

Novartis' Secukinumab Excels In 2 Phase 3 Trials In AS

By Estel Grace Masangkay

Novartis posted positive results from two Phase 3 trials investigating its drug AIN457 (secukinumab) in ankylosing spondylitis, a debilitating spine disorder.

Secukinumab is a fully human monoclonal antibody and selective inhibitor of interleukin-17A (IL-17A). The drug is the first to target IL-17A in ankylosing spondylitis (AS) with positive Phase 3 results. IL-17A is a protein that triggers inflammation in inflammatory arthritic diseases, such as AS and psoriasis. Last month, Novartis reported positive results from two Phase 3 trials of the drug in adult onset psoriatic arthritis (PsA).

Ankylosing spondylitis is a common type of spondyloarthropathy (SpA), a family of long-term inflammatory diseases that include psoriatic arthritis. AS is characterized by painful swelling, stiffness, fatigue, persistent back pain, and curvature of the spine. In severe cases, fusion of the spine and irreversible bone formation occurs. The condition affects up to 1 percent of the general population.

The drug met its primary and secondary endpoints in two pivotal Phase 3 studies, MEASURE 1 and MEASURE 2, in an estimated 600 patients with AS. Primary endpoints included improvement in disease signs and symptoms compared to placebo. The company said it will present detailed results of the studies at a future medical congress.

Vasant Narasimhan, Global Head of Development at Novartis Pharmaceuticals, said, “We are thrilled to see positive results with secukinumab in AS, a gravely debilitating condition with a significant remaining unmet need as up to 40 percent of patients do not respond to anti-TNF therapies. With these results in AS and the recently announced positive results in psoriatic arthritis, we now have data from four Phase 3 trials of secukinumab in spondyloarthropathies, which we look forward to presenting at a congress later this year."

This month, the company also reported the support of the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) panel to the U.S. Food and Drug Administration (FDA) for the regulatory approval of secukinumab as treatment for moderate-to-severe plaque psoriasis.