Drug reduced relapse rate by 31% compared with placebo.
Sanofi-aventis reported positive two-year data from a Phase III trial with its oral disease-modifying multiple sclerosis (MS) drug teriflunomide. Results from the international thousand-patient TEMSO study showed that both evaluated doses of teriflunomide reduced the annualized MS relapse rate by 31% in comparison with placebo. The 14 mg and 7 mg teriflunomide doses resulted in a reduction in the risk of disability progression by 30% and 24%, respectively, when compared with placebo.
The drug was also well tolerated, Sanofi-aventis notes. Teriflunomide therapy did not result in any increase in treatment-emergent adverse events or treatment discontinuation, compared with placebo.
Sanofi-aventis says the TEMSO trial data is the first study finding to emerge from a large Phase III trial with teriflunomide. They were presented at today’s “European Committee for Treatment and Research in Multiple Sclerosis” congress in Gothenburg, Sweden. Additional eight-year follow-up data from an open-label extension to a previous Phase II teriflunomide trial were also presented at the meeting. These showed that the drug was well tolerated during eight years of continuous use and had a safety profile consistent with that reported for the first 36 weeks of the double-blind phase of the study.
“We were very satisfied to see how TEMSO demonstrated that teriflunomide successfully reduced relapse rate but also reduced the time to disability progression for the highest dose,” comments Paul O’Connor, director of the MS clinic at St. Michael’s Hospital in Toronto and lead TEMSO trial investigator.
Two additional Phase III trials with teriflunomide are currently ongoing in relapsing MS patients. The drug is also being evaluated in a Phase III trial in early MS or CIS (clinically isolated syndrome) patients.