The Lancet Publishes SELECT Study Evaluating Efficacy and Safety of
Daclizumab HYP in Multiple Sclerosis
-Data Demonstrated That DAC HYP Significantly Reduced Annualized Relapse Rate
by up to 54 Percent at One Year-
-Phase 3 Study Underway to Further Assess Once-Monthly DAC HYP for Multiple
WESTON, Mass. -- April 4, 2013
Today Biogen Idec (NASDAQ: 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 DACHYP 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
Detailed data from the SELECT study were also recently presented at the 65th
Annual Meeting of the American Academy of Neurology in San Diego.
SELECT was a Phase 2b global, randomized, double-blind, placebo-controlled,
one-year, dose-ranging study to determine the safety and efficacy of DACHYP
in patients with RRMS. SELECT evaluated two doses of DACHYP: 150mg or 300mg
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: 150mg of
DACHYP(n=208), 300 mg of DACHYP(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).
About Daclizumab High-Yield Process
Daclizumab high-yield process (DAC HYP) is a subcutaneous formulation of
daclizumab in late-stage clinical development for the treatment of RRMS, the
most common form of MS. DAC HYP is a humanized monoclonal antibody that binds
to CD25, a receptor subunit that is expressed at high levels on T cells that
are thought to become abnormally activated in autoimmune conditions, such as
MS. Data from previous clinical trials showed that DAC HYP increases
CD56^bright Natural Killer (NK) cells, which target the activated immune cells
that can play a key role in MS without causing general immune cell depletion.
DAC HYP is currently being studied in the DECIDE Phase 3 clinical trial, which
is evaluating the efficacy and safety of once-monthly subcutaneous DAC HYP as
a monotherapy compared to interferon beta-1a therapy.
Biogen Idec is developing DAC HYP in collaboration with AbbVie, Inc.
Through cutting-edge science and medicine,Biogen Idecdiscovers, develops and
delivers to patients worldwide innovative therapies for the treatment of
neurodegenerative diseases, hemophilia and autoimmune disorders. Founded in
1978,Biogen Idecis the world’s oldest independent biotechnology company.
Patients worldwide benefit from its leading multiple sclerosis therapies, and
the company generates more than$5 billionin annual revenues. For product
labeling, press releases and additional information about the company, please
Biogen Idec Safe Harbor
This press release contains forward-looking statements, including statements
about the development and effects of DAC HYP as a potential new treatment for
MS. These statements may be identified by words such as "believe," "expect,"
"may," "plan," "will" and similar expressions, and are based on our current
beliefs and expectations. Drug development involves a high degree of risk.
Factors which could cause actual results to differ materially from our current
expectations include the risk that unexpected concerns may arise from
additional data or analysis, regulatory authorities may require additional
information or may fail to approve any potential new therapy, or we may
encounter other unexpected hurdles. For more detailed information on the risks
and uncertainties associated with our drug development and other activities,
please read the Risk Factors section of our most recent annual or quarterly
report and in other reports we have filed with the SEC. Any forward-looking
statements speak only as of the date of this press release and we assume no
obligation to update any forward-looking statements.
Kate Niazi-Sai, +1-781-464-3260
Carlo Tanzi, Ph.D., +1-781-464-2442
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