Teva Pharmaceutical Industries and Active Biotech have reported positive initial results from a two-year Phase III study of oral laquinimod as a treatment for relapsing-remitting multiple sclerosis.
The study results showed that patients receiving 0.6mg daily oral laquinimod experienced a statistically significant reduction in annualised relapse rate compared to those receiving a placebo.
The study also met additional clinical endpoints including significant reduction in disability progression, as measured by the expanded disability severity scale.
The multinational, multicentre, randomised, double blind and placebo-controlled study was designed to evaluate the efficacy, safety and tolerability of laquinimod in patients with multiple sclerosis.
The study, conducted at 139 sites in 24 countries, enrolled 1,106 patients with the condition who were randomised to receive a once-daily oral dose of 0.6mg laquinimod or placebo.
Professor Giancarlo Comi, the principal investigator, said that the study met its primary endpoint while maintaining a very good safety profile.
“Laquinimod demonstrated a significant reduction in the progression of disability which may be explained by its unique mechanism of action that includes neuroprotective properties,” Comi added.
Following the successful results, Teva has filed a patent application for the use of laquinimod in slowing the progression of disability in multiple sclerosis patients.
Multiple sclerosis is a progressive, demyelinating disease of the central nervous system, which is the leading cause of neurological disability in young adults. It affects more than 400,000 people in the US.
