Biogen (BIIB), Abbott (ABT) Report DAC HYP Met Primary Endpoint in SELECT Trial
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Biogen Idec (Nasdaq: BIIB) and Abbott (NYSE: ABT) reports additional results from the SELECT Phase 2b trial, the first of two registrational studies designed to evaluate the investigational compound daclizumab high-yield process (DAC HYP) in people with relapsing-remitting multiple sclerosis (RRMS). Results showed that DAC HYP, administered subcutaneously once every four weeks, met the trial’s primary endpoint by significantly reducing the annualized relapse rate by 54 percent in the 150 mg dose group (p<0.0001) and 50 percent in the 300 mg dose group (p=0.0002) compared to the placebo group at one year.
In SELECT, more than 90 percent of patients in the DAC HYP groups completed the study. In addition to meeting the primary endpoint, both doses of DAC HYP met key secondary endpoints, including measures of magnetic resonance imaging (MRI). In a sub-study for a pre-specified subset of patients, both 150 mg and 300 mg of DAC HYP provided a significant reduction in the cumulative number of new gadolinium-enhancing (Gd+) lesions between weeks eight and 24 (69%; 78%; p<0.0001). Both doses also provided a significant reduction in new or newly enlarging T2 hyperintense lesions (70%; 79%; p<0.0001). In a tertiary endpoint, both 150 mg and 300 mg of DAC HYP also significantly reduced the number of new Gd+ lesions on the week 52 MRI (79%; 86%; p<0.0001).
In SELECT, more than 90 percent of patients in the DAC HYP groups completed the study. In addition to meeting the primary endpoint, both doses of DAC HYP met key secondary endpoints, including measures of magnetic resonance imaging (MRI). In a sub-study for a pre-specified subset of patients, both 150 mg and 300 mg of DAC HYP provided a significant reduction in the cumulative number of new gadolinium-enhancing (Gd+) lesions between weeks eight and 24 (69%; 78%; p<0.0001). Both doses also provided a significant reduction in new or newly enlarging T2 hyperintense lesions (70%; 79%; p<0.0001). In a tertiary endpoint, both 150 mg and 300 mg of DAC HYP also significantly reduced the number of new Gd+ lesions on the week 52 MRI (79%; 86%; p<0.0001).
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