Teva and Active Biotech Announce CONCERTO trial of Laquinimod trial fails

The CONCERTO trial of laquinimod in patients with relapsing-remitting multiple sclerosis did not meet its primary endpoint.

 Teva Pharmaceutical Industries Ltd. and its partner Active Biotech reported on Friday that the CONCERTO trial of its ethical drug laquinimod in patients with relapsing-remitting multiple sclerosis (RRMS) had not met its primary endpoint. This was the result of a trial of laquinimod (0.6 mg/daily capsules) versus a placebo to evaluate the time to Confirmed Disability Progression (CDP) after at least 3 months.Laquinimod is a once-daily oral, investigational, selective aryl hydrocarbon receptor (AhR) activator targeting neurodegeneration and inflammation with a novel mechanism of action being developed for the treatment of RRMS, primary-progressive MS (PPMS), and Huntington disease.Teva’s share price rose 0.9% on Friday. In the past year, Teva has fallen 43%, and its market cap has shrunk to $31.7 billion.

Earlier this year, Teva and Active Biotech announced that they were ceasing to give high doses of laquinimod in two studies of multiple sclerosis following non-fatal cardiac events reported in eight patients.

“We have learned a great deal from the CONCERTO trial and we will continue our analysis of the data,” said Teva president of Global R&D and chief scientific officer Michael Hayden. “Although we are disappointed by not meeting the primary endpoint, we did see positive results on a number of secondary and exploratory endpoints which fuels our belief in the potential of laquinimod as a possible treatment for neurodegenerative diseases. While we have no current plans to further pursue laquinimod in RRMS, we are continuing to study it in two other trials.”

Teva continues to evaluate the potential of laquinimod in primary progressive MS (PPMS) and Huntington disease (HD) with two other clinical trials unaffected by the results of the CONCERTO trial. Complete data from the CONCERTO trial will be published in a scientific journal and presented at a future medical meeting.

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