Sanofi moves teriflunomide into phase III MS trials
pharmafile | October 26, 2010 | News story | Research and Development | MS, Sanofi, Sanofi-Aventis, TERACLES, multiple sclerosis, relapsing multiple sclerosis, teriflunomide
Sanofi-Aventis is to begin the first phase III study of an oral drug as an add-on to standard therapy in relapsing multiple sclerosis (RMS).
TERACLES will look at once-daily teriflunomide, a promising pipeline compound, in conjunction with interferon beta (IFN β), versus patients treated with (IFN β) alone.
Studies of teriflunomide in monotherapy for RMS are also ongoing. The company hailed the imminent commencement of the phase III trial as a “tremendous milestone”.
“We are confident that teriflunomide is an excellent candidate for assessing innovative adjunct therapy in MS considering the positive effect observed when it was used in adjunct with IFN β in the phase II study,” said Marc Cluzel, Sanofi’s executive vice president, R&D.
In phase II trials teriflunomide with IFN β significantly improved disease control – evaluated by MRI activity – beyond IFN β plus oral placebo at one year.
The primary endpoint of TERACLES is to reduce the annualised relapse rate compared to IFN β plus oral placebo tablets in patients treated for six months with IFN β prior to randomisation.
Secondary endpoints include documenting disease activity measured by MRI, the time to disability progression and overall safety.
“We hope that this study will replicate the additional efficacy and safety profile we observed in the phase II trial,” said Mark Freedman, Professor of Neurology, at the University of Ottawa.
The potential rewards are attractive for Sanofi: last month Novartis’ new oral drug Gilenya (fingolimod) was approved by the FDA as a first line option for RMS and analysts predict peak annual sales of $2.5 billion.
Gilenya is set to significantly alter the way the disease is treated, taking market share from existing injectable IFN β drugs after one key study showed it cut relapses by 52% at one year compared with IFN β-1a IM.
Merck KGaA is also striving for a breakthrough in this area, and is to appeal the EMA’s rejection in September of its own oral RMS treatment Movectro. An FDA decision is expected before the end of the year.
Adam Hill
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