23 October 2014 - 23 October 2014 - Swiss Novartis' (VTX:NOVN) reported Thursday that its fully human monoclonal antibody AIN457 (secukinumab) had achieved primary and key secondary objectives in two Phase III trials, dubbed MEASURE 1 and MEASURE 2, in patients with ankylosing spondylitis (AS).

According to Novartis, this makes secukinumab the first selective IL-17A inhibitor to hit a primary goal in two pivotal Phase III trials, showing improvement in active AS patients' symptoms versus placebo.

MEASURE 1 and MEASURE 2 are randomised, placebo-controlled, multi-centre trials designed to demonstrate efficacy of secukinumab in AS compared to placebo and to evaluate safety, tolerability and long-term effectiveness. The trials enrolled a combined total of around 600 patients. The Assessment of Spondyloarthritis International Society criterion (ASAS 20) was the primary goal of the trials. Key goals also included improvements in signs and symptoms of the disease versus placebo and associated improvements in physical function and quality of life. Secukinumab demonstrated an acceptable safety profile in both trials which was consistent with that observed in the large psoriasis clinical trial programme, involving about 4,000 patients.

The secukinumab results in AS follow positive topline findings in psoriatic arthritis (PsA) announced in September.

Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals, noted that AS presents a singnificant remaining unmet need, because up to 40% of patients do not respond to standard of care anti-TNF (tumour-necrosis-factor) therapies. He said that with the encouraging findings from the two trials in AS and the recently announced positive results in PsA, the company now has data from four Phase III trials of secukinumab in spondyloarthropathies which Novartis anticipates presenting at a medical congress later this year.

Novartis plans to submit joint regulatory applications for secukinumab in AS and PsA in 2015. This follows the secukinumab global regulatory applications for moderate-to-severe plaque psoriasis which were filed in October 2013 with regulatory decisions expected in late 2014 or early 2015.

AS is a common type of spondyloarthropathy (SpA), a family of long-term diseases of joints. Up to 70% of patients with severe AS can develop spinal fusion, considerably reducing mobility and quality of life. Currently, anti-TNF medicines are the only biologic therapies available for patients with AS.

Secukinumab (AIN457) is a fully human monoclonal antibody selectively neutralising the action of IL-17A - a protein that stimulates inflammation and which is central to the development of psoriasis and other inflammatory arthritic diseases, including AS.

Besides AS, secukinumab is also in studies for the treatment of PsA and rheumatoid arthritis (RA).