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Biogen Idec, Abbott Start Phase III MS Trial

Biogen Idec and Abbott began enrollment in a global Phase III study evaluating the efficacy and safety of daclizumab compared to interferon beta-1a (AVONEX) in patients with relapsing-remitting multiple sclerosis (RRMS).

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Biogen Idec and Abbott began enrollment in a global Phase III study evaluating the efficacy and safety of daclizumab compared to interferon beta-1a (AVONEX) in patients with relapsing-remitting multiple sclerosis (RRMS). The trial, called DECIDE, will investigate a subcutaneous formulation of daclizumab intended for monthly administration, which has the potential to provide a new immunomodulatory approach for treating MS. Abbott will receive a $30 million milestone payment for the enrollment of the first patient in the trial.

Daclizumab, a humanized monoclonal antibody, is believed to work by selectively targeting activated T-cells without causing general T-cell depletion. The randomized, double-blind, active-comparator study is expected to enroll approximately 1,500 RRMS patients in 28 countries. Daclizumab is also being investigated in a Phase IIb registration-enabling SELECT trial, evaluating the efficacy and safety of monthly subcutaneous doses of either 150 mg or 300 mg of daclizumab monotherapy.

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