Teva Pharmaceutical Industries and Active Biotech have reported positive results from the two-year Phase III of laquinimod, an oral, once-daily, investigational immunomodulator for the treatment of relapsing forms of multiple sclerosis (MS).
In the study, laquinimod demonstrated a statistically significant 23% reduction in annualised relapse rate, the primary endpoint.
Laquinimod resulted in a significant 36% reduction in the risk of confirmed disability progression, as measured by expanded disability status scale (EDSS).
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.
Laquinimod was safe and well-tolerated without immunosuppressive effects.
The overall frequencies of adverse events, including incidence of infections, was comparable to those observed in the placebo group.
The two-year multinational, multicentre randomised, double blind, placebo-controlled study was designed to evaluate the efficacy, safety and tolerability of laquinimod in MS patients.
The study was conducted at 139 sites in 24 countries and enrolled 1,106 MS patients, who were randomised to receive a once-daily oral dose of 0.6mg laquinimod or placebo.
The second laquinimod Phase III study is currently ongoing with results anticipated in the third quarter of 2011, following which regulatory submissions will be planned in the US and the EU.
MS is the leading cause of neurological disability in young adults, which is estimated to affect more than 400,000 people in the US.