Multiple sclerosis patients on laquinimod experienced a 23% reduction in annual relapse rate compared to those on a placebo during a two year Phase III clinical trial (ALLEGRO study), researchers announced at the 63rd Annual Meeting of the American Academy of Neurology in Honolulu, Hawaii.

The trial consisted of 1,106 patients with relapsing-remitting multiple sclerosis (MS) in 24 nations. They were given 0.6 milligrams of laquinimod once a day oral dose, or a similar-looking placebo for 24 months. 80% of the laquinimod patients and 77% of those on a placebo completed the two-year course.

The 23% lower annual relapse rate among the laquinimod patients versus the placebo ones is “statistically significant”, the researchers said. There was also a 36% reduction in disability progression as measured by Expanded Disability Status Scale, and 33% less brain atrophy among the laquinimod participants.

Lead author, Giancarlo Comi, MD, director of the Department of Neurology and Institute of Experimental Neurology at the Scientific Institute and University Vita-Salute San Raffaele in Milan, Italy, said:

“These exciting results confirm that laquinimod has a significant impact on progression of disability and disease activity, while maintaining a high safety profile. This may be attributed to the novel mechanism of action of laquinimod, which effectively and safely addressed both the acute inflammatory activity and the accumulation of irreversible tissue damage. This suggests a substantial future role for laquinimod in the treatment of MS.”

Dr. Comi added that laquinimod was shown to be well tolerated and safe, without immunosuppressive effects. Adverse events overall frequencies were low and comparable to those experienced by participants in the placebo group. The most commonly reported adverse events included headaches, nasopharyngitis, and back pain. Although the laquinimod patients had a greater incidence of elevated liver enzyme than the placebo participants, the elevations were “transient, asymptomatic and reversible”. Among the laquinimod patients no deaths were reported.

Dr. Comi added:

“The incidence of liver enzyme elevation was higher in laquinimod treated patients. However, these elevations were temporary, reversible and did not lead to any signs of liver problems.”

Laquinimod, developed by Active Biotch and Teva Pharmaceuticals, is an experimental immunomodulator.

The trial was financed by Teva Pharmaceuticals.

Professor Yitzhak Peterburg, Teva’s Group Vice President, Global Branded Products, said:

“We are very enthusiastic about the results of the ALLEGRO study, which demonstrated that laquinimod significantly slows the progression of disability, the primary goal of MS treatment. Given the efficacy, safety and tolerability data to date, laquinimod may present a very promising treatment option to the MS community.”

According to a Teva Pharmaceuticals communiqué:

“The second laquinimod Phase III study, BRAVO, is currently ongoing with results anticipated in the third quarter of 2011. Regulatory submissions are planned in the U.S. and the EU following the availability of the BRAVO results.”

Sources: American Academy of Neurology Annual Meeting and Teva Pharmaceuticals.

Written by Christian Nordqvist