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news.Teriflunomide, a novel orally available immunomodulatory therapy for multiple sclerosis
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Sanofi-aventis has reported the results of a phase II study with teriflunomide, a novel orally available immunomodulatory therapy for multiple sclerosis (MS). Teriflunomide is currently being explored in a phase III program for relapsing forms of MS.
Teriflunomide is a selective inhibitor of de novo pyrimidine synthesis which modulates the proliferation of Tand B-lymphocytes, and has antiproliferative and anti-inflammatory properties.
In the 24-week double blind, placebo-controlled, randomized, three-arm multinational phase II clinical study, conducted in 116 patients with relapsing-remitting MS, patients received one of the two study doses (7mg or 14mg once daily) or placebo on top of stable background therapy with IFN- beta.
The study’s primary endpoints were the tolerability and safety of 7mg and 14mg doses of teriflunomide administered orally once daily.
Reportedly, in a 24-week study, teriflunomide, when added to background stable therapy with interferon (IFN-beta), showed acceptable tolerance and safety (primary endpoints) and improvements of the disease as measured by magnetic resonance imaging (MRI) with the two doses tested, versus placebo.
With regard to efficacy, disease control as assessed through MRI activity measures, improved beyond that achieved with IFN-beta therapy alone as shown by reductions in cerebral inflammatory lesions, compared to placebo.
Mark Freedman, professor of neurology, department of medicine, University of Ottawa, said: “This exploratory study shows that teriflunomide can be administered on top of stable therapy with interferon with an acceptable safety and tolerability profile. Although the study was not powered to test for efficacy, we were pleased to see a significant additional effect of teriflunomide over interferon-beta alone in reducing MRI activity measures. These results encourage longer term studies to establish the clinical benefit of combination treatment in this disease where effective new therapies are eagerly awaited.”