Today Biogen Idec BIIB announced that results from the daclizumab
high-yield process (DAC HYP) SELECT clinical trial have been published as an
online article in The Lancet. SELECT was a Phase 2b study designed to
determine the efficacy and safety of DAC HYP in patients with
relapsing-remitting multiple sclerosis (RRMS).
Published results demonstrate that both 150 mg and 300 mg subcutaneous
injections of DAC HYP, administered once every four weeks, met the study's
primary endpoint by significantly reducing annualized relapse rate (ARR) by 54
percent (p<0.0001) and 50 percent (p=0.0002), respectively, compared to
placebo at one year. In addition, results demonstrated that DAC HYP reduced
multiple sclerosis (MS) brain lesions compared to placebo.
“DAC HYP represents the type of innovative research we are focused on
cultivating as part of our MS pipeline because it potentially targets the
disease in a new way,” said Gilmore O'Neill, M.D., vice president, Medical
Research at Biogen Idec. “Based on these initial data from SELECT, we believe
DAC HYP would complement our robust portfolio of four approved MS products by
potentially offering people with MS a new treatment alternative. We look
forward to continuing to work with our partners at AbbVie to progress the DAC
HYP program further.”
Both doses of DAC HYP met key secondary endpoints in the study by
significantly reducing the proportion of patients who relapsed at one year, as
well as MS brain lesion activity, including the cumulative number of new
gadolinium-enhancing (Gd+) lesions between weeks eight and 24 and the number
of new or newly enlarging T2-hyperintense lesions at one year. Both doses of
DAC HYP also demonstrated a trend in improvements in quality of life (QoL)
compared to placebo as measured by the Multiple Sclerosis Impact Scale
(MSIS-29) physical impact score.
“Because MS is unique to each person, we need a variety of treatment options
to attack the disease in different ways,” said Ralf Gold, M.D.,
professor/chair of the Department of Neurology at St.
Josef-Hospital/Ruhr-University in Bochum, Germany, and author on the
manuscript published in The Lancet. “The results seen in SELECT suggest that
DAC HYP potentially offers a new approach to treating people with MS.”
As a tertiary endpoint, SELECT findings also demonstrated that DAC HYP had a
positive effect on slowing disability progression, as measured by the Expanded
Disability Status Scale (EDSS).
The overall incidence of adverse events (AEs) and treatment discontinuations
was similar in all study groups (79 percent placebo group, 73 percent DAC HYP
150 mg group and 76 percent DAC HYP 300 mg group). Serious adverse events
(SAEs) over the course of the study, excluding MS relapse, occurred in six
percent in the placebo group, seven percent in the 150 mg dose group and nine
percent in the 300 mg dose group. Serious infections (2 percent versus 0
percent), serious cutaneous events (1 percent versus 0 percent) and liver
function test abnormalities greater than five times the upper limit of normal
(4 percent versus < 1 percent) occurred more frequently in the DAC HYP groups
than in the placebo group. There was one death in SELECT due to a complication
of a psoas muscle abscess in a patient recovering from a serious skin adverse
event.
Detailed data from the SELECT study were also recently presented at the 65th
Annual Meeting of the American Academy of Neurology in San Diego.
About SELECT
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: 150 mg or 300 mg
administered every four weeks. The primary endpoint was the reduction in ARR
in patients with RRMS at one year. Secondary endpoints included the reduction
in the cumulative number of new Gd+ lesions between weeks eight and 24, the
reduction in the number of new or newly enlarging T2-hyperintense lesions at
one year, and the proportion of patients with RRMS who relapsed, as well as
improvement in quality of life measures in patients with RRMS at one year.
Additional endpoints assessed the safety and tolerability of DAC HYP.
The SELECT study analyzed 621 randomized patients, 18 to 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 0.0 and 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: 150 mg of
DAC HYP (n=208), 300 mg of DAC HYP (n=209), and placebo (n=204).
Detailed results of SELECT are available in the manuscript “Daclizumab
high-yield process in relapsing-remitting multiple sclerosis (SELECT): a
randomised, double-blind, placebo-controlled trial,” which is available on the
Web site of The Lancet at (www.thelancet.com).
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