Sanofi-Aventis has reported positive Phase III study results of teriflunomide, an oral disease modifier for the treatment of relapsing multiple sclerosis.
The double-blind, randomised, placebo-controlled and multinational two-year trial enrolled 1,088 patients with relapsing multiple sclerosis aged 18 to 55 years old from 21 countries.
Patients were randomised to receive placebo or teriflunomide, 7mg or 14mg once daily, and followed for a period of 108 weeks.
The primary endpoint was an annualised relapse rate, while the secondary endpoint was the time to sustained disability progression.
The study results showed that both doses of teriflunomide significantly reduced the annualised relapse rate by 31% when compared with the placebo.
Teriflunomide reduced the risk of disability progression sustained at 12 weeks by 30% with a 14mg dose and 24% with a 7mg dose, and it was well-tolerated without any major safety concerns.
The drug also lowered the brain disease activity on a range of MRI measures, including a reduction of burden of disease by 39% after the 7mg dose and 67% after the 14mg dose, relative to the placebo.
Multiple sclerosis is a progressively disabling disease that affects about two million people around the world.
