According to a company press release,multiple sclerosis Clinical Trial in a 60-month, phase III clinical trial involving 1,651 people with secondary progressive MS, the experimental oral therapy siponimod (BAF312, Novartis Pharmaceuticals AG) met its primary endpoint of reducing the risk of disability progression compared with inactive placebo. These results were announced in an August 25, 2016 press release from Novartis. Further results are being presented at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in September.
Background: Siponimod (BAF312) is an experimental immune system-modulating therapy that was designed to be a more selective sphingosine 1-phosphate receptor modulator than Gilenya®(fingolimod, Novartis International AG). Gilenya, was approved in 2010 for adults with relapsing forms of MS to reduce the frequency of clinical relapses and to delay the accumulation of physical disability.
previously demonstrated safety and efficacy on MRI scans in a phase II study in people with relapsing-remitting MS (The Lancet Neurology, 2013 Aug;12(8):756-67). Siponimod is thought to act by retaining certain white blood cells in the body’s lymph nodes, keeping them out of circulation and from entering the central nervous system. Siponimod also distributes effectively to the central nervous system (brain and spinal cord) where it may have direct anti-inflammatory or other effects.
The Study: Participants were randomly assigned to take siponimod or placebo capsules daily for up to 60 months. The primary endpoint of the study was reducing the risk of disability progression, as measured by the EDSS scale at three months. According to an August 25, 2016 press release from Novartis, siponimod achieved this endpoint compared with placebo.
Secondary endpoints included reducing the risk of disability progression as measured by the EDSS at six months versus placebo, the risk of worsening mobility as measured by the timed 25-foot walk test, disease activity as observed on MRI scans, relapse rate, and safety/ tolerability. These results have not yet been released.Further results are being presented at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in September.
Comment: “We look forward to seeing the full results of this study,” said Bruce F. Bebo, PhD, Executive Vice President, Research at the National MS Society. “We hope these results lead to a treatment advance for people living with secondary progressive MS.”
About Multiple Sclerosis: Multiple sclerosis Clinical Trial is an unpredictable, often disabling disease of the central nervous system that disrupts the flow of information within the brain, and between the brain and body. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide