Novartis AIN457 (secukinumab) is the first ever IL-17A inhibitor to meet primary endpoint in two Phase III studies in psoriatic arthritis

Novartis International AG / Novartis AIN457 (secukinumab) is the first ever IL-17A inhibitor to meet primary endpoint in two Phase III studies in psoriatic arthritis . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• Secukinumab met primary and key secondary endpoints in two pivotal Phase III studies showing superiority to placebo in patients with adult onset psoriatic arthritis (PsA) 

• PsA is a debilitating, long-lasting condition that causes inflammation of joints and skin and affects up to 30% of people with psoriasis globally[1],[2] 

• Many people with PsA do not respond to current standard of care, with approximately 45% of people dissatisfied with current treatments[3] 

• Secukinumab is the first interleukin-17A (IL-17A) inhibitor with positive Phase III results in PsA and regulatory submissions are planned for 2015

Basel, September 25, 2014 - Novartis today announced that two pivotal Phase III studies (FUTURE 1 and FUTURE 2) of AIN457 (secukinumab) in psoriatic arthritis (PsA) met primary and key secondary endpoints. Endpoints included improving signs and symptoms of psoriatic arthritis (PsA), including improving peripheral joint disease and preventing joint damage versus placebo, while delivering clear or almost clear skin (PASI 90). Secukinumab is an investigational medicine that works by stopping the action of interleukin-17A (IL-17A)[4], a protein that is central to the development of inflammatory diseases[5]. FUTURE 1 and FUTURE 2 enrolled a combined total of more than 1,000 patients. Detailed results of the studies will be presented at an upcoming medical congress.

PsA is a long-lasting, complex condition involving joint inflammation (arthritis), and usually occurs in combination with psoriasis[1]. There are many different features of PsA that affect the skin, joints and tendons, resulting in irreversible joint damage in many patients[1]. It is linked with significant disability, poor quality of life, reduced life expectancy[1] and major economic burden for the society[6]-[8]. Although TNF (tumor-necrosis-factor) inhibitors, the current standard of care for PsA[10],[11], can improve clinical symptoms[11]-[16], responses may diminish over time. Furthermore, many patients with PsA do not respond to or tolerate these agents[4], leaving an unmet need.