Active Biotech’s partner Teva Pharmaceutical Industries will amend the trial design in a Phase 2 study of laquinimod in Huntington’s disease.
The amendment consists of dropping the highest of three doses (1.5 mg/day) in the trial while keeping two remaining active doses (0.5 and 1 mg/day) unchanged. This is a precautionary measure in the interest of patient safety being suggested by Teva to the Data Safety Monitory Board (DSMB) for the LEGATO-HD trial.
The DSMB accepted the recommendation after reviewing data which observed cardiovascular incidents in patients receiving the high doses of laquinimod in two multiple sclerosis trials as reported on January 4, 2016. No cardiovascular events have been observed for any dose of the LEGATO-HD trial. Teva will continue in its commitment to study laquinimod in Huntington’s disease.
Currently the mechanism of the cardiovascular events in the MS trials remains unknown. Although no specific time-to-event patterns have been identified, cardiovascular risk factors and demographics may play a role.
Source: Active Biotech