Active Bio and Teva’s laquinimod strikes out again, this time in progressive MS

Laquinimod is still in trials for other indications including Huntington's disease.

Active Biotech and Teva’s laquinimod—once billed as a successor to multiple sclerosis blockbuster Copaxone—has hit yet another snag after failing a phase 2 trial in primary progressive MS.

Earlier this year the two partners shelved laquinimod for the relapsing-remitting form of MS after the results of the CONCERTO trial showed no benefit, and at the time said they were still hopeful of a positive result in the phase 2 ARPEGGIO trial in primary progressive MS, which affects 10-15% of patients and is considered a tougher treatment challenge.

Now, those hopes have been dashed after top-line data from the study reveal that a daily, oral dose of the drug failed to meet the primary objective of reducing brain atrophy, measured by the percent brain volume change (PBVC) over the course of the 48-week trial. There was also no evidence of any effect on disability progression, a key secondary endpoint.

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In a terse statement, Active Biotech noted there was a reduction in new brain lesions observed with the drug, but prospects for the drug in MS now seem to have pretty much vanished, bringing to an end a massive and turbulent clinical effort that extends back to a deal between the company and Teva in 2004. The partners tried and failed to win approval for the drug in Europe, with their application rejected by the EMA’s Committee for Medicinal Products for Human Use (CHMP) in 2014, and the last few years have seen a string of negative trials for the drug in MS.

Laquinimod is still in a phase 2 trial in patients with Huntington’s disease, another neurodegenerative disorder, with results due in the middle of 2018, as well as mid-stage studies in Crohn’s disease and lupus erythematosus.

Complete data from the ARPEGGIO trial will be published in a scientific journal and presented at a future medical meeting, said Active Biotech, which saw its shares pulverized by the announcement—down 45% at the time of writing.

The latest setback for the program comes as new Teva CEO Kåre Schultz embarks on sweeping changes to its R&D operations that have claimed the job of R&D chief Michael Hayden.