The second Phase III study evaluating the efficacy of Genzyme’s teriflunomide therapy against relapsing forms of multiple sclerosis found the once-daily oral drug to be no less effective than injectable interferon beta 1a (Rebif®). Data from the 324-patient Tenere trial showed no statistical superiority between the Rebif and teriflunomide arms (7 mg and 14 mg) in terms of risk of treatment failure, the primary endpoint defined as occurrence of a confirmed relapse or permanent treatment discontinuation for any cause.
Genzyme says it will include the trial results in its application to the European regulatory authorities for approval of teriflunomide, which is projected for submission during the first quarter of 2012. A marketing application submitted in the U.S. was accepted for review by FDA in October.
The clinical development program for teriflunomide includes five efficacy studies that are either under way or have been completed. In October Genzyme reported positive new data from the pivotal Phase III Temso trial demonstrating that teriflunomide therapy significantly reduced annualized rates of relapse leading to hospitalization, and confirming the safety profile and efficacy of the drug over a six-year period.
In addition to the Temso and Tenere studies, the Phase III Tower study is ongoing in people with relapsing MS. The Topic trial is investigating teriflunomide in patients with early MS or clinically isolated syndrome. The Teracles study is evaluating the drug as an adjunct to interferon-beta.