Teva and Active Biotech announced that a Phase III study investigating the experimental drug laquinimod in patients with relapsing-remitting multiple sclerosis (RRMS) failed to meet its primary endpoint. Michael Hayden, president of global R&D at Teva, said "although we are disappointed by not meeting the primary endpoint, we did see positive results on a number of secondary and exploratory endpoints."
The CONCERTO trial randomised patients with RRMS to receive one of two oral doses of laquinimod or placebo. However in January last year, Teva and Active Biotech said that the higher dose of the drug would no longer be used in the study, as well as in the ARPEGGIO trial, following the occurrence of non-fatal cardiovascular events.
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The main goal of the CONCERTO trial was the time to confirmed disability progression (CDP) after at least three months as measured by change in the Expanded Disability Status Scale (EDSS). Meanwhile, secondary endpoints examined the impact of laquinimod on change in brain volume from baseline to month 15 and time to first confirmed relapse and CDP measured by EDSS after at least six and nine months versus placebo.
According to the companies, laquinimod showed a 40-percent improvement compared to placebo on change in brain volume, while other "encouraging" results were seen on the secondary endpoint of time to first relapse, with the drug demonstrating a risk reduction of 28 percent. Teva and Active Biotech added that for laquinimod, adverse events reported in 5 percent or more of patients were headache, nasopharyngitis, back pain and arthralgia. Complete data from the CONCERTO trial will be presented at an upcoming medical meeting.
Hayden remarked "while we have no current plans to further pursue laquinimod in RRMS, we are continuing to study it in two other trials." Teva is currently evaluating laquinimod in primary progressive MS and Huntington disease.
For related analysis, read ViewPoints: Few surprises as laquinimod passes quietly into the night.
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