Novartis’ Phase III trials of ankylosing spondylitis drug secukinumab meets primary endpoint

23rd October 2014 (Last Updated October 23rd, 2014 18:30)

Swiss Pharmaceutical firm Novartis has reported positive results from its Phase III MEASURE 1 and MEASURE 2 trials of AIN457 (secukinumab), an investigational medicine, in patients with ankylosing spondylitis (AS), a common type of spondyloarthropathy (SpA).

Swiss Pharmaceutical firm Novartis has reported positive results from its Phase III MEASURE 1 and MEASURE 2 trials of AIN457 (secukinumab), an investigational medicine, in patients with ankylosing spondylitis (AS), a common type of spondyloarthropathy (SpA).

SpA is a family of long-term diseases impacting joints (inflammatory diseases), which includes other conditions such as psoriatic arthritis (PsA).

The company said that the trials met primary and key secondary endpoints, which included improvements in signs and symptoms of the disease versus placebo and associated improvements in physical function and quality of life.

Primary endpoint of the trial was the Assessment of Spondyloarthritis International Society criterion (ASAS 20).

"In addition to AS, secukinumab is also begins evaluated in clinical trials to treat PsA and rheumatoid arthritis (RA)."

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

Around 600 patients with AS were enrolled in both the MEASURE 1 and MEASURE 2 trials.

Novartis Pharmaceuticals global head of Development Vasant Narasimhan 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% 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 III trials of secukinumab in spondyloarthropathies which we look forward to presenting at a congress later this year."

The results of secukinumab in AS follow positive top-line data in PsA reported in September, and the company is planning for a joint regulatory filing of the drug for both the indications in 2015.

Both the randomised, placebo-controlled, multicentre MEASURE 1 and MEASURE 2 trials were designed to show efficacy of secukinumab in AS compared to placebo and to evaluate the safety, tolerability and long-term effectiveness.

In addition to AS, secukinumab is also begins evaluated in clinical trials to treat PsA and rheumatoid arthritis (RA).