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Teva reports successful results of Phase III study with oral Laquinimod in Multiple Sclerosis patients

Posted Dec 10 2010 3:49pm
Dec 09, 2010 (M2 EQUITYBITES via COMTEX) -- Pharmaceutical company Teva Pharmaceutical Industries Ltd (Nasdaq: TEVA | PowerRating ) and Active Biotech (Nordic:ACTI), a biotechnology company, announced today successful initial results from the two-year Phase III ALLEGRO study.

The companies said that the study met primary endpoint of reducing annualised relapse rate. The study 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.

Also, additional clinical endpoints, including significant reduction in disability progression, as measured by Expanded Disability Severity Scale (EDSS), were also achieved.

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, ALLEGRO and BRAVO.

The results indicated that 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.

The companies said that additional analyses of the ALLEGRO 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 US Food and Drug Administration (FDA) in February 2009. The second phase III study, BRAVO, is still ongoing with results anticipated in the third quarter of 2011. Regulatory submissions in the US and the EU are expected to follow.

In addition to the ongoing MS clinical studies , laquinimod is currently in Phase II development for Crohn's disease and Lupus, and is being studied in other autoimmune diseases.

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