Phase 3 Study of Laquinimod for Multiple Sclerosis
Teva Pharmaceutical and Active Biotech announced results from their Phase 3 ALLEGRO study of laquinimod for the treatment of relapsing forms of multiple sclerosis (MS). ALLEGRO was a two-year multinational, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, safety and tolerability of laquinimod in MS patients. The study enrolled 1,106 MS patients who were randomized to receive a once-daily oral dose of 0.6mg laquinimod or matching placebo. The primary outcome measured was the number of confirmed relapses while secondary measures included confirmed disability progression and changes in MRI active lesions.
The results showed that laquinimod demonstrated a statistically significant 23% reduction in annualized relapse rate (P=0.0024). Secondary endpoints were met with a significant 36% reduction in the risk of confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS) (P=0.0122). Treatment also showed a 33% reduction in brain atrophy (P<0.0001).
Laquinimod is an oral immunomodulator being developed for the treatment of MS.