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news.Teva Pharmaceutical Industries and Active Biotech have completed patient enrollment for the Phase III clinical trial, Allegro, in relapsing-remitting multiple sclerosis.
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The pivotal Allegro study is designed to evaluate the efficacy, safety and tolerability of the oral investigational compound, laquinimod, versus placebo in the treatment of relapsing-remitting multiple sclerosis (RRMS).
The Allegro study completed patient screening at the end of the third quarter of 2008. Recruitment of over 1,000 patients at 152 sites throughout North America, Europe and Asia was finalized in November. The completion of recruitment triggers a milestone payment of $5 million to Active Biotech from Teva Pharmaceutical Industries.
A second pivotal Phase III clinical trial evaluating laquinimod, called Bravo, is currently enrolling patients globally. The Bravo trial aims to provide risk-benefit data for laquinimod versus Avonex, an available injectable treatment.
Previous data from the Phase IIb core study and its 36-week extension period demonstrated the rapid onset and sustained efficacy of laquinimod in reducing disease activity, as well as the favorable safety profile of the compound, said Teva.