Oral agent meets MS trial primary endpoint

Teriflunomide, a novel oral disease modifier under investigation by sanofi-aventis (S-A) for the treatment of relapsing multiple sclerosis (RMS), has been shown in the phase III TEMSO trial to reduce annualised relapse rate by 31 per cent, compared with placebo. This means the trial attained its primary endpoint of statistically significantly reducing annualised relapse rate. 

In the two-year trial, which included 1,088 RMS patients, teriflunomide was also shown to be well tolerated, to reduce disease activity (as measured by various magnetic resonance imaging [MRI] metrics) and to reduce the risk of disease progression by 30 per cent at the higher dose (14mg) and by 24 per cent for the lower (7mg) dose.

The trial results were announced on October 15 at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) congress in Gothenburg, Sweden. Along with the TEMSO results, eight-year follow-up results of an open-label extension to a phase II study, demonstrating long-term safety, were presented. 

TOWER and TENERE, two other phase III trials of teriflunomide in RMS patients, are ongoing. TOPIC, a phase III trial of teriflunomide in early MS or clinically isolated syndrome (CIS) patients, is also in progress.

"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 with a favourable safety profile for multiple sclerosis patients with relapses and emerges as a potential new first-line treatment option in this patient population," said Dr Paul O'Connor, director of the MS Clinic at St Michael's Hospital, Toronto, Canada and principal investigator of the TEMSO study.

These positive results represent the latest in a series of announcements about oral MS therapies. Merck Serono's cladribine recently received a negative opinion from the European Medical Association's (EMA) Committee for Medicinal Products for Human Use (CHMP), while Novartis' Gilenya (fingolimod) has gained approval from the US Food and Drug Administration (FDA).