Teva announces successful results of Phase III with oral laquinimod for multiple sclerosis

10-Dec-2010 - Israel

Teva Pharmaceutical Industries Ltd. and Active Biotech announced initial results from the two-year Phase III ALLEGRO study, which demonstrated that relapsing-remitting multiple sclerosis (MS) patients treated with 0.6 mg daily oral laquinimod experienced a statistically significant reduction in annualized relapse rate compared to placebo. Additional clinical endpoints, including significant reduction in disability progression, as measured by Expanded Disability Severity Scale (EDSS), were also achieved.

Laquinimod was safe and well-tolerated. The overall frequencies of adverse events were comparable to those observed in the placebo group. No deaths were reported in laquinimod-treated patients. Overall incidence of infections was similar between the two arms of the trial.

"This pivotal study met its primary endpoint while maintaining a very good safety profile," says Principal Investigator, Professor Giancarlo Comi, Director of the Department of Neurology and Institute of Experimental Neurology at the University Vite Salute, San Raffaele, Italy. "Laquinimod demonstrated a significant reduction in the progression of disability which may be explained by its unique mechanism of action that includes neuroprotective properties. Laquinimod may therefore be a promising therapeutic option for the MS community."

Additional analyses of the ALLEGRO study data are ongoing, and detailed results will be submitted for presentation at a scientific conference during the first half of 2011.

https://www.bionity.com/en/news/127144/teva-announces-successful-results-of-phase-iii-with-oral-laquinimod-for-multiple-sclerosis.html