Phase 3 study of oral laquinimod for multiple sclerosis
Teva and Active Biotech announced initial results from their Phase 3 trial of oral laquinimod for the treatment of relapsing-remitting multiple sclerosis (MS). This trial, known as ALLEGRO with an enrollment of 1106 patients, was a two-year multi-national, multi-center randomized, double blind, placebo-controlled study designed to evaluate the efficacy, safety and tolerability of laquinimod in MS patients. Patients were randomized to receive a once-daily oral dose of 0.6 mg laquinimod or matching placebo. The study met its primary outcome (number of confirmed relapses); this was demonstrated by a statistically significant reduction in annualized relapse rate in patients treated with 0.6 mg daily oral laquinimod compared to placebo. Secondary measures included confirmed disability progression and changes in MRI active lesions.
Laquinimod is a once-daily, oral immunomodulatory compound being developed as a disease-modifying treatment for MS.
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