Novartis' Secukinumab Highly Effective In Phase 3 Psoriasis Trials

Novartis declared positive results from two Phase III studies investigating secukinumab (AIN457) in psoriasis patients.

Secukinumab is a fully human monoclonal antibody designed to selectively bind to and neutralize interleukin-17A (IL-17A), a cytokine found to be a cause of psoriasis. Research shows that IL-17A, found in high concentrations in affected skin areas, influences autoimmune response in disorders such as moderate to severe plaque psoriasis.

Psoriasis is a chronic autoimmune disease in which thick and panoptic skin lesions or plaques develop on the skin. Patients suffer itching, pain, and scaling symptoms linked with physical and psychological impacts.

In the Phase III trials ERASURE and FIXTURE, over 70 percent of patients who received secukinumab 300 mg reported clear or almost clear skin during the first 16 weeks of therapy. FIXTURE pitted secukinumab directly against Enbrel, Pfizer’s $9 billion a year blockbuster drug for psoriasis, as well as placebo. Findings show that secukinumab showed significant superiority in improving patients’ moderate-to-severe psoriasis symptoms.

Results of the trials were published online in New England Journal of Medicine (NEJM). “The publication of two pivotal phase III studies in NEJM showing consistently high efficacy of secukinumab validates IL-17A as a preferred treatment target in psoriasis. These data, which are part of our regulatory submissions, are important as there is a high need for effective new therapies for people living with this debilitating disease,” said David Epstein, Division Head at Novartis.

The company has filed regulatory applications for secukinumab in the U.S., EU, and Japan. Depending on its expected approvals, Novartis could launch the drug in late 2014 or early 2015. Evaluate Pharma analysts pegged secukinumab’s expected sales at around $570 million by 2018. Together with other new psoriasis drugs such as AstraZeneca and Amgen’s brodalumab, Eli Lilly’s ixekizumab, and Celgene’s apremilast, Novartis’ secukinumab is anticipated to bring in around $9 billion by 2023 in global sales, says market research firm Visiongain. Indeed, there must be some truth to this, considering Biotech firm Celgene’s shares recently climbed in spite of revealing that apremilast failed to meet a Phase III trial in ankylosing spondylitis.