Laquinimod, which has crossed the blood brain barrier to potentially have a direct effect on resident CNS inflammation and neurodegeneration in animal models, is a CNS-active immunomodulator exhibiting a novel mechanism of action.
The 1,800 patient-based multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod 0.6 mg/day or 1.2 mg/day in subjects with RRMS.
The study will also assess patients for up to 24 months, after which patients will continue to an active treatment period with laquinimod for additional 24 months, claims the company.
Time to confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), is the primary outcome measure of the study.
The study will also demonstrate the impact of laquinimod on endpoints such as percent change in brain volume, as well as other clinical and MRI markers of disease activity.
Rocky Mountain Multiple Sclerosis Center medical director, University of Colorado Denver neurology professor and study principal investigator Dr Timothy Vollmer said, "Previous Phase III studies in more than 2,400 people with RRMS suggest a unique profile of laquinimod, directly affecting the neurodegenerative processes that lead to disability progression, the main concern in the treatment of RRMS."
In addition to RRMS, Laquinimod is currently in clinical development for Crohn’s disease and Lupus.