Biogen Idec announced results from the daclizumab high-yield process (DAC HYP) SELECT clinical trial. DAC HYP, a subcutaneous formulation of daclizumab for the treatment of relapsing-remitting multiple sclerosis (RRMS), is a humanized monoclonal antibody that binds to CD25, a receptor subunit that is expressed at high levels on T cells which are thought to become abnormally activated in autoimmune conditions.
SELECT was a Phase 2b global, randomized, double-blind, placebo-controlled, one-year, dose-ranging study to determine the safety and efficacy of DAC HYP in patients with RRMS. SELECT evaluated two doses of DAC HYP, 150mg or 300mg administered every four weeks. The SELECT study analyzed 621 randomized patients, 18–55 years of age. Patients participating in the study were required to have RRMS per McDonald criteria 1–4 and a baseline EDSS score between 0–5.5, as well as either one or more MS relapses in the 12 months prior to randomization, or Gd+ lesion activity on a brain MRI within six weeks of randomization. Patients were randomized in a ratio of 1:1:1 to three treatment groups: 150mg of DAC HYP (n=208), 300mg of DAC HYP (n=209), and placebo (n=204). The primary endpoint was the reduction in annualized relapse rate (ARR) in patients with RRMS at one year
Results demonstrated that both 150mg and 300mg subcutaneous injections of DAC HYP, administered once every four weeks, met the study’s primary endpoint by significantly reducing ARR by 54% (P<0.0001) and 50% (P =0.0002), respectively, compared to placebo at one year.
DAC HYP is currently being studied in the DECIDE Phase 3 clinical trial, which is evaluating the efficacy and safety of once-monthly subcutaneous DAC HYP as a monotherapy compared to interferon beta-1a therapy.
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