Teva Pharmaceutical and Active Biotech have announced initial results from the two-year Phase III ALLEGRO study, which demonstrated that relapsing-remitting multiple sclerosis 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.
Laquinimod demonstrated a significant reduction in the progression of disability which may be explained by its unique mechanism of action that includes neuroprotective properties.
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 FDA ( Food and Drug Administration ) in February 2009. The second phase III study, BRAVO is still ongoing with results anticipated in the third quarter of 2011.
Laquinimod is a novel once-daily, oral immunomodulatory compound being developed as a disease-modifying treatment for multiple sclerosis. The global Phase III clinical development program evaluating oral Laquinimod in multiple sclerosis consists of two pivotal studies, ALLEGRO and BRAVO:
The first clinical study, ALLEGRO, was a two-year multi-national, multi-center randomized, double blind, placebo-controlled study designed to evaluate the efficacy, safety and tolerability of Laquinimod in multiple sclerosis patients. The study was conducted at 139 sites in 24 countries and enrolled 1,106 patients. Patients were randomized to receive a once-daily oral dose of 0.6 mg Laquinimod or matching placebo. The primary outcome measure was the number of confirmed relapses; secondary measures included confirmed disability progression and changes in MRI active lesions,. Patients who completed the ALLEGRO study are offered to join an open-label extension phase, in which they will be treated with Laquinimod 0.6 mg daily until the drug is commercially available.
The second clinical study, BRAVO, is a two-year, multi-national, multi-center, randomized, double-blind, parallel-group, placebo-controlled study designed to compare the safety, efficacy and tolerability of a once-daily oral dose of 0.6 mg Laquinimod over placebo and to perform a comparative risk-benefit assessment between Laquinimod and Interferon beta-1a ( Avonex, REbif ). Enrollment of 1,332 patients at 154 sites in the United States, Europe, Israel and South Africa was completed in June 2009. BRAVO study results are expected in the third quarter of 2011.
Source: Teva, 2010
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