Today Biogen
Idec (NASDAQ: BIIB) and Abbott
(NYSE: ABT) announced 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. These data were presented in a
late-breaking oral presentation at the 5th Joint Triennial
Congress of the European and Americas Committees on Treatment and
Research in Multiple Sclerosis (ECTRIMS and ACTRIMS) in Amsterdam.
"These data from SELECT position DAC HYP as a potentially impactful new
treatment option for multiple sclerosis (MS) with the convenience of a
once-monthly subcutaneous injection, a first for patients," said Alfred
Sandrock, M.D., Biogen Idec's Senior Vice President of Development. "We
hope to see a similar effect on relapses and disability progression in
the Phase 3 DECIDE trial, DAC HYP's second registrational trial, which
is currently underway."
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).
"We continue to be very encouraged by the clinical profile for DAC HYP,
particularly the annualized relapse rate and disability progression
results that we have seen in the data from the SELECT study," said John
M. Leonard, M.D., Abbott's Senior Vice President of Global
Pharmaceutical Research & Development. "We are pleased that the
Abbott-Biogen Idec collaboration continues to make excellent progress in
advancing the development of a potential new MS therapy."
DAC HYP reduced the proportion of patients who relapsed by 55 percent in
the 150 mg group (p<0.0001) and by 51 percent in the 300 mg group
(p=0.0003). The results from the trial also showed an improvement in
quality of life (QoL), as measured by the Multiple Sclerosis Impact
Scale (MSIS-29) physical score, in the DAC HYP 150 mg group (p=0.0007)
and a trend favoring benefit in the 300 mg group (p=0.1210) compared to
the placebo group.
SELECT also investigated the effect of DAC HYP on disability progression
as measured by the Expanded Disability Status Scale (EDSS) as a tertiary
endpoint.