Genzyme reported initial positive results from a Phase III study of oral teriflunomide in patients with relapsing forms of multiple sclerosis (MS). Patients receiving teriflunomide 14 mg had a statistically significant reduction in annualized relapse rate and risk of sustained accumulation of disability, the primary and secondary endpoints, respectively.
Teriflunomide has completed two other Phase III studies in relapsing MS, Temso and Tenere. Marketing applications for teriflunomide for the treatment of relapsing forms of MS are under review by FDA, EMA, and other regulatory authorities. Aubagio is the proprietary name submitted to health authorities for teriflunomide.
The Tower (teriflunomide oral in people with relapsing remitting multiple sclerosis) trial compared once-daily treatment with either 7 mg or 14 mg oral teriflunomide against placebo. This double-blind, multi-center trial enrolled 1,169 patients between the ages of 18 to 55.
The proposed 14 mg commercial dose resulted in a 36.3% reduction in annualized relapse rate. It also generated a 31.5% reduction in the risk of 12-week sustained accumulation of disability, as measured by the Expanded Disability Status Scale (EDSS).
A 22.3% reduction in annualized relapse rate was observed in patients treated with teriflunomide 7 mg compared to placebo. There was no statistically significant difference observed between teriflunomide 7 mg and placebo, however, for the risk of 12-week sustained accumulation of disability.
Patients who completed the trial were followed for a period between 48 and 173 weeks. The average duration of teriflunomide exposure in Tower was 18 months. Adverse events observed in the trial were consistent with previous clinical trials with teriflunomide in MS.
“These encouraging results are consistent with the results on relapse rate and disability that were observed in the Temso study and highlight the promise of teriflunomide as a potential new treatment for many patients with relapsing MS,” says Genzyme president and CEO, David Meeker, M.D.
Teriflunomide is being studied in a clinical program that is expected to include more than 5,000 trial participants in 36 countries. Besides the three completed Phase III trials in relapsing MS, the Phase III study Topic is being conducted in early MS or clinically isolated syndrome (CIS). Teriflunomide is also being evaluated as an adjunctive therapy to interferon-β in the Phase III Teracles trial. With up to 10 years of continuous use in a Phase II extension, teriflunomide has the longest clinical experience of any investigational oral MS therapy, according to Genzyme.
Teriflunomide is an immunomodulator, and research supports that teriflunomide inhibits the proliferation of stimulated T and B lymphocytes in the periphery thought to be responsible for the damaging inflammatory process in MS, while generally maintaining normal immune function.