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Teva drops laquinimod for most common form of MS after failed trial

CONCERTO study showed no disability progression improvements over placebo


Teva and Active Biotech have suffered another setback in their efforts to develop laquinimod for multiple sclerosis and are abandoning the programme.

The results of the long-awaited CONCERTO trial of laquinimod in the relapsing-remitting form of MS found that the drug was unable to show an improvement over placebo in reducing the progression of disability - the main outcome measure in the study.

Laquinimod remains in the phase II ARPEGGIO trial involving patients with primary progressive MS which affects 10-15% of patients but as this is considered a tougher form of MS to treat, hopes are diminishing of a positive outcome with results due later this year. Shares in Active Biotech have lost two thirds of their value in response to the news while Teva is also down slightly.

There were positive signs of efficacy on various secondary endpoints - particularly changes in brain volume which are an indicator of disability progression over time and time to first relapse - but on balance Teva said it has "no current plans to further pursue laquinimod in RRMS".

The decision means that a mammoth effort to bring the drug to market as an MS therapy - punctuated by an EU rejection in 2014 - has ended in disappointment. The two companies have been collaborating on laquinimod since 2004, but insist they are still fully behind development of the drug for PPMS and Huntington's disease.

Some 18 months ago Teva and Sweden's Active Biotech were forced to halt treatment with higher doses of laquinimod in CONCERTO and ARPEGGIO after cardiovascular side effects were seen in some patients, but continued to test lower doses of the drug. And earlier Teva reported disappointing results from a phase III trial of the drug in relapsing-remitting MS, which showed it was unable to reduce the annual rate of relapse compared to placebo.

"Although we are disappointed by not meeting the primary endpoint, we did see positive results on a number of secondary and exploratory endpoints," said Teva's chief scientific officer Michael Hayden.

That "fuels our belief in the potential of laquinimod as a possible treatment for neurodegenerative diseases", he added.

Article by
Phil Taylor

8th May 2017

From: Research



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