Biogen Idec and Abbott have released top-line results from a double-blind, dose-ranging, randomized and placebo-controlled Select Phase 2b trial evaluating the experimental compound daclizumab high-yield process (DAC HYP) in patients with relapsing-remitting multiple sclerosis (RRMS) over one year. The results of the trial demonstrated that the DAC HYP showed reduction in annualized relapse rate by 54% when administered subcutaneously once every four weeks in 150mg dose arm and 50% reduction in the 300 mg dose arm in comparison to placebo arm at one year.
DAC HYP met secondary endpoints in 150mg and 300mg arms as well as demonstrated a trend towards improvement in quality of life measures at one year.
While assessing the effect of DAC HYP on disability progression, the drug demonstrated reduction in the risk of sustained disability progression at one year by 57% in the 150mg dose arm and by 43% in the 300mg dose arm compared to placebo.
Biogen Idec Research and Development executive vice president Doug Williams said the positive results for DAC HYP, along with previous clinical data, support their continued investigation of this candidate as a promising new approach to treating multiple sclerosis.”We hope to confirm the results of Select in our second registrational trial, Decide,” Williams said.
