Novartis To Present Phase 3 Data For Secukinumab At ACR
Novartis reported that it will present data from four Phase 3 trials of secukinumab (AIN457) investigating the drug in psoriatic arthritis (PsA) and ankylosing spondylitis (AS) at the American College of Rheumatology (ACR) Congress taking place this month.
Secukinumab is a human monoclonal antibody (mAb) designed to selectively bind to and neutralize interleukin-17A (IL-17A), a cytokine implicated in immune responses and inflammatory arthritic diseases. The drug is a first-in-class IL-17A inhibitor that works to stop the release of pro-inflammatory cytokines, which are messenger proteins that influence autoimmune responses. Last month, the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the U.S. Food and Drug Administration (FDA) announced its positive recommendation for secukinumab as treatment for moderate-to-severe plaque psoriasis.
The company will present findings from the two pivotal Phase 3 studies FUTURE 1 and FUTURE 2 in PsA and two pivotal Phase 3 studies MEASURE 1 and MEASURE 2 in AS. All four studies met their primary endpoints. Novartis will deliver the following presentations at ACR:
- FUTURE 1: Secukinumab, a Human Anti-Interleukin-17A Monoclonal Antibody, Improves Active Psoriatic Arthritis and Inhibits Radiographic Progression: Efficacy and Safety Data from a Phase 3 Randomized, Multicenter, Double-Blind, Placebo-Controlled Study
- FUTURE 1: Secukinumab, A Monoclonal Antibody to Interleukin-17A, Provides Significant and Sustained Inhibition of Joint Structural Damage in Active Psoriatic Arthritis Regardless of Prior TNF Inhibitors or Concomitant Methotrexate: a Phase 3 Randomized, Double-Blind, Placebo-Controlled Study
- MEASURE 1: Secukinumab, a Monoclonal Antibody to Interleukin-17A, Significantly Improves Signs and Symptoms of Active Ankylosing Spondylitis: Results of a 52-Week Phase 3 Randomized Placebo-Controlled Trial with Intravenous Loading and Subcutaneous Maintenance Dosing
- FUTURE 2: Secukinumab, a Human Anti-Interleukin-17A Monoclonal Antibody, Improves Active Psoriatic Arthritis: 24-Week Efficacy and Safety Data from a Phase 3 Randomized, Multicenter, Double-Blind, Placebo-Controlled Study Using Subcutaneous Dosing
Psoriatic arthritis is an inflammatory disease that is characterized by joint pain and stiffness, irreversible joint damage, and persistent tendonitis. Ankylosing spondylitis is also an inflammatory disease characterized by spinal fusion, reduced mobility, and decreased quality of life. PsA may affect between 0.3 to 1 percent of the general population while AS occurs in up to 1 percent of the general population.
“There remains a significant unmet need for new Psoriatic Arthritis and Ankylosing Spondylitis therapies as many patients have an inadequate or no response to available treatments… We're excited about the Phase 3 data we're presenting at ACR 2014 and what these results could mean for patients,” said Vasant Narasimhan, Global Head of Development at Novartis Pharmaceuticals.
Novartis said it will file global regulatory application for secukinumab in PsA and AS in 2015.