Biogen Idec and Abbott Announce Positive Top-Line Results from the First Registrational Trial for Daclizumab HYP in Relapsing-Remitting Multiple Sclerosis

Biogen Idec BIIB and Abbott ABT today announced positive top-line results from SELECT, a global, registrational Phase 2b clinical trial designed to evaluate the investigational compound daclizumab high-yield process in people with relapsing-remitting multiple sclerosis over one year. Results showed that DAC HYP, administered subcutaneously once every four weeks, significantly reduced annualized relapse rate by 54 percent in the 150 mg dose arm (p< 0.0001) and 50 percent in the 300 mg dose arm (p=0.0002) compared to the placebo arm at one year. DAC HYP met key secondary endpoints for the 150 mg and 300 mg arms, respectively, providing a highly statistically significant reduction in the cumulative number of new gadolinium-enhancing (Gd+) lesions between weeks eight and 24 (69%; 78%); in the number of new or newly enlarging T2 hyperintense lesions at one year (70%; 79%); and in the reduction in the proportion of patients who relapsed (55%; 51%). DAC HYP also showed a trend toward improvement in quality of life measures at one year.