Phase III trial data has demonstrated that treatment using the oral immunomodulatory candidate laquinimod leads to significant reductions in annualized relapse rates in patients with relapsing-remitting multiple sclerosis (MS), Teva Pharmaceuticals reports. The drug also led to significant reductions in disability progression, as measured by the Expanded Disability Severity Scale.
The pivotal placebo-controlled Allegro trial involved 1,106 MS patients in 24 countries, and evaluated the safety and efficacy of once-daily laquinimod in comparison with placebo. The primary efficacy outcome was the number of confirmed relapses. Secondary measures included confirmed disability progression and changes in MRI-evaluated active lesions.
Allegro was the first of two Phase III studies with laquinimod in MS patients. Results from the completed Bravo trial are expected during the latter part of 2011. This placebo-controlled trial in 1,332 patients compared the safety, efficacy, and tolerability of laquinimod therapy with treatment using interferon beta-1a. Laquinimod is separately undergoing Phase II development for the treatment of Crohn’s disease and lupus nephritis.
Teva negotiated exclusive worldwide rights to develop, register, manufacture, and commercialize laquinimod from Active Biotech in 2004. Under terms of the deal Active received an up-front fee of $5 million, and could be eligible to development, regulatory, and sales milestones of $92 million, plus double-digit sales royalties. Teva is responsible for carrying out and funding all clinical development of the drug. Laquinimod received fast-track designation from the FDA in 2009.