Novartis reports positive results from two Phase III trials of secukinumab in psoriatic arthritis

25th September 2014 (Last Updated September 25th, 2014 18:30)

Swiss drug-maker Novartis has reported positive results from two of its pivotal Phase III trials (FUTURE 1 and FUTURE 2) of an investigational medicine secukinumab (AIN457) in patients with psoriatic arthritis (PsA).

Swiss drug-maker Novartis has reported positive results from two of its pivotal Phase III trials (FUTURE 1 and FUTURE 2) of an investigational medicine secukinumab (AIN457) in patients with psoriatic arthritis (PsA).

Secukinumab works by stopping the action of interleukin-17A (IL-17A), a protein that is central to the development of inflammatory diseases.

The company said both the randomised, placebo-controlled, multi-centre FUTURE 1 and FUTURE 2 trials met primary and key secondary endpoints.

The trials were designed to show efficacy of secukinumab in PsA compared to placebo as well as to evaluate safety and tolerability.

"The trials were designed to show efficacy of secukinumab in PsA compared to placebo as well as to evaluate safety and tolerability."

Primary endpoint in the trials was the American College of Rheumatology response criteria (ACR20).

The endpoints of these trials are improving signs and symptoms of PsA, including improving peripheral joint disease and preventing joint damage versus placebo, while delivering clear or almost clear skin (PASI 90).

The company has enrolled a combined total of more than 1,000 patients in these two Phase III trials.

PsA is a debilitating, long-lasting condition that causes inflammation of joints and skin and affects up to 30% of people with psoriasis across the world.

Novartis Pharmaceuticals global head of Development Vasant Narasimhan said: "Building on the positive data previously reported in psoriasis, we are excited to present the first Phase III 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."

The company plans to submit global regulatory applications for secukinumab in PsA in 2015.

In October 2013, the company submitted global regulatory applications for secukinumab to treat moderate-to-severe plaque psoriasis, while approvals are expected in late 2014 or early 2015.