Phase 3 Trial Update of Laquinimod for Multiple Sclerosis
Teva Pharmaceuticals and Active Biotech announced results from the laquinimod Phase 3 ALLEGRO study in patients with relapsing-remitting multiple sclerosis (RRMS). Data from the two-year study showed that oral once-daily laquinimod reduced inflammatory disease activity as measured by clinical relapses and Magnetic Resonance Imaging (MRI), slowed disability progression and decreased brain tissue loss, while maintaining a favorable safety and tolerability profile.
The ALLEGRO study enrolled 1,106 MS patients. Patients were randomized to receive a once-daily oral dose of 0.6mg laquinimod or matching placebo. In the study, laquinimod showed a statistically significant 23% reduction in annualized relapse rate (P=0.002), the primary endpoint, along with a significant 36% reduction in the risk of confirmed disability progression, as measured by Expanded Disability Status Scale (EDSS). Additional analyses showed that the actual proportion of patients with confirmed disability progression at the last assessment was lower in the laquinimod group than in the placebo group (9.8% vs. 14%; P=0.04). Treatment with laquinimod was also associated with a significant reduction in brain tissue loss, as measured by a 33% reduction in progression of brain atrophy (P<0.001).
Laquinimod is an oral, once-daily immunomodulator with a novel mechanism of action being developed for the treatment of MS.