Active Biotech and Teva have delivered more bad news from their clinical development of laquinimod, this time from a phase 2 trial in Huntington’s disease.
The study did not meet its primary endpoint, comparing changes in motor skills after one year of treatment. It did, however, meet its secondary endpoint of reducing brain atrophy, and safety results were in line with expected events, the companies said in a statement. Active Bio’s stock fell 36% on the news, while Teva’s mostly held steady.
Once seen as a potential blockbuster heir to Copaxone in multiple sclerosis, and capable of generating up to $4 billion a year, Active Bio’s aryl hydrocarbon receptor activator would go on to see a series of disappointing efficacy results in later-phase trials, in both relapsing-remitting and primary progressive MS. Teva has held the rights to laquinimod’s commercialization and development since 2004.
The Huntington’s trial, the last listed for laquinimod in Teva’s pipeline, randomized 351 patients with an average age of about 44 years and compared three doses to placebo, at 0.5 mg, 1.0 mg and 1.5 mg daily. Patients were evaluated using the Unified Huntington's Disease Rating Scale - Total Motor Score.
After cardiovascular safety concerns arose in a previous study of higher doses of laquinimod in MS, Teva discontinued the 1.5-mg arm as a precaution in January 2016, though no similar trends were seen in the Huntington’s study.
By the end, 287 patients had completed the study and 65 terminated early, including 30 who stopped when the 1.5-mg dose was halted.
Results were not released, but the data will continue to be analyzed, as Teva plans to submit the study for presentations at future medical meetings and for publication.