September 25, 2014
By Krystle Vermes, BioSpace.com Breaking News Staff
Today, Novartis announced that two Phase 3 studies for its psoriatic arthritis drug have met primary and secondary end points. AIN457, also known as secukinumab, was looked at for treating the signs and symptoms of the disease, which can impact those who have psoriasis. The studies revealed that AIN457 could improve peripheral joint disease and prevent joint damage, versus the placebo, while delivering clear skin.
“Building on the positive data previously reported in psoriasis, we are excited to present the first Phase III results of secukinumab in PsA,” said Vasant Narasimhan, Global Head of Development at Novartis Pharmaceuticals. “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.”
AIN457 works by stopping the action of interleukin-17A, which is a protein central to the development of many inflammatory diseases. The Phase 3 studies, known as Future 1 and Future 2, looked at more than 1,000 patients. The results of the studies will be presented at an upcoming medical congress.
Future 1 and Future 2 were randomized, placebo-controlled studies designed to show the efficacy of AIN457, as well as determine its safety and tolerability. Its safety profile was consistent with results from a previous psoriasis clinical trial program that involved more than 4,000 patients.
Regulatory applications for the drug are planned for 2015. This comes after regulatory applications for moderate-to-severe plaque psoriasis were filed in October 2013.
Between 0.3 percent and 1 percent of the general population may be affected by psoriatic arthritis, and approximately one in four people may be undiagnosed. This condition is an inflammatory disease that is linked to poor quality of life and decreased life expectancy. About 30 percent of people who have psoriasis also have psoriatic arthritis.
Secukinumab is the first medicine that selectively targets the IL-17A protein and has shown positive Phase 3 results fro the treatment of psoriatic arthritis. AIN457, a fully human monoclonal antibody, is also being looked at for the treatment of ankylosing spondylitis and rheumatoid arthritis. It is currently undergoing clinical trials for the treatment of these specific diseases.
