Teva Pharmaceutical Industries and Active Biotech of Sweden yesterday announced successful initial results for orally-administered Laquinimod from a decisive, two-year Phase III Allegro study performed on multiple sclerosis patients. The study demonstrated a statistically significant reduction in annualized relapse rates among patients taking the treatment, along with significant reduction in disability progression as measured by Expanded Disability Severity Scale (EDSS ).
Laquinimod was shown to be safe and well-tolerated in tests against a placebo. The overall frequency of observed side effects among patients administered the drug was similar to that in the control group. Analysis of the study findings continues, with detailed results to be presented at a leading scientific conference in the first half of 2011.
Laquinimod is a novel, once-daily, oral immunomodulatory compound being developed as a disease-modifying treatment for MS. The global Phase III clinical development program evaluating oral Laquinimod in MS consists of two pivotal studies.
Concern over competition for Teva's proprietary MS treatment Copaxone from generic versions of the drug and from Novartis International's Gilenya, the first available oral MS medicine, has hurt the company's share price, which has fallen 23% from its peak in March.
MS is the leading cause of neurological disability among young adults. It is estimated that more than 400,000 people in the United States are affected by the disease, and that two million people may be affected worldwide.
"This pivotal study met its primary endpoint while maintaining a very good safety profile," says the 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." Shlomo Yanai, CEO of Teva, said: "We are very pleased to have achieved this major milestone in the development of oral Laquinimod, a novel therapy that can potentially improve the lives of many MS patients in a safe way."
Additional analyses of the study data are ongoing, and detailed results will be submitted for presentation at a leading scientific conference during the first half of 2011.
Laquinimod received Fast Track designation from the U.S. Food and Drug Administration in February 2009. The second phase III study is still ongoing with results anticipated in the third quarter of 2011. Regulatory submissions in the U.S. and the European Union will then follow.
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