Biogen Announces Positive Phase 2 Study Results for Cutaneous Lupus
Erythematosus (CLE) and Systemic Lupus Erythematosus (SLE)
Today, Biogen Inc. (Nasdaq: BIIB) announced positive top-line
results from the Phase 2 LILAC study evaluating the efficacy and
safety of BIIB059, a fully humanized IgG1 monoclonal antibody (mAb)
targeting blood dendritic cell antigen 2 (BDCA2) expressed on
plasmacytoid dendritic cells, in patients with lupus.
“There is substantial unmet medical need for people with lupus
given the limited number of treatment options available to help
manage this difficult-to-treat and chronic disease,” said Nathalie
Franchimont, M.D., Ph.D., Vice President, Lupus and Multiple
Sclerosis Portfolio at Biogen. “We are excited by the LILAC study
results, and the potential for BIIB059 to be a meaningful new
treatment option for patients living with lupus. We also believe
these results support Biogen’s goal of continuing to build a
multi-franchise portfolio by bringing potential new treatment
options to people with great unmet medical need.”
LILAC was a two-part study that evaluated BIIB059 versus placebo
in individuals with active cutaneous lupus erythematosus (CLE),
including chronic and subacute subtypes, with or without systemic
manifestations and in individuals with systemic lupus erythematosus
(SLE) with active joint and skin manifestations.
The CLE part of the study met its primary endpoint (p<0.001)
by demonstrating a dose response of BIIB059 on the percent change
from baseline in the Cutaneous Lupus Erythematosus Disease Area and
Severity Index Activity (CLASI-A) score at Week 16 in individuals
with CLE. Study participants with CLE treated with 50 mg, 150 mg
and 450 mg of BIIB059 experienced reductions in CLASI-A scores of
40.9 percent (p=0.008), 48.0 percent (p=0.001) and 42.5 percent
(p=0.001), respectively, versus 14.5 percent with placebo. CLASI-A
is a well-defined and reliable outcome measure that has been shown
to detect meaningful change in CLE skin disease activity.
The SLE part of the study also met its primary endpoint of
reducing disease activity in individuals with SLE as measured by
change from baseline in total active joint count at Week 24
(treatment difference = -3.4 for BIIB059 450 mg versus placebo,
p=0.037). Total active joint count is the total number of tender or
swollen joints, with joint involvement being a common symptom in
people with SLE. In addition, improvements in skin disease and
overall disease activity were consistently observed across multiple
secondary endpoints.
The safety and tolerability profile of BIIB059 supports its
continued development. Detailed results of the LILAC study will be
made available in a future scientific forum.
About BIIB059BIIB059, discovered and developed
exclusively by Biogen, is a fully humanized IgG1 monoclonal
antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2)
currently being investigated for the treatment of CLE and SLE.
BDCA2 is a receptor that is uniquely expressed on a subset of human
immune cells called Plasmacytoid Dendritic Cells (pDCs), and it has
been shown to reduce inflammatory cytokine production from pDCs,
including type-I IFN (IFN-I). Inflammatory mediators are thought to
play a major role in the pathogenesis of lupus.
About the Phase 2 LILAC StudyThe Phase 2 LILAC
study was a two-part, randomized, double blind, placebo-controlled
study that enrolled 264 individuals to evaluate the safety and
efficacy of BIIB059 versus placebo in individuals with active
cutaneous lupus erythematosus (CLE), including chronic and subacute
subtypes, with or without systemic manifestations and in
individuals with systemic lupus erythematosus (SLE) with active
joint and skin manifestations. The CLE part of the study, which
enrolled 132 patients, investigated either a 50 mg, 150 mg or 450
mg dose versus placebo in individuals with active CLE. The primary
endpoint was dose-response of BIIB059 as measured by percent change
from baseline in the Cutaneous Lupus Erythematosus Disease Area and
Severity Index Activity (CLASI-A) Score at Week 16. The SLE part of
the study, which enrolled 132 patients, evaluated a 450 mg dose
versus placebo in individuals with active SLE. The primary endpoint
was change from baseline in total active joint count at Week
24.
About Cutaneous Lupus Erythematosus (CLE) and Systemic
Lupus Erythematosus (SLE)CLE is a chronic autoimmune
disease where the body’s immune system attacks healthy skin, often
causing rashes and skin lesions which can be painful or itchy. CLE
is associated with a decrease in quality of life and increased
depression. In some forms of the disease, patients may experience
scarring, skin atrophy and alopecia.
SLE is a chronic autoimmune disease that affects multiple organ
systems, with periods of illness or flares alternating with periods
of remission. SLE can present itself in several ways including
rash, arthritis, anemia, thrombocytopenia, serositis, nephritis,
seizures or psychosis. SLE is associated with a greater risk of
death from causes such as infection and cardiovascular disease.
About Biogen At Biogen, our mission is clear:
we are pioneers in neuroscience. Biogen discovers, develops and
delivers worldwide innovative therapies for people living with
serious neurological and neurodegenerative diseases as well as
related therapeutic adjacencies. One of the world’s first global
biotechnology companies, Biogen was founded in 1978 by Charles
Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners
Walter Gilbert and Phillip Sharp. Today Biogen has the leading
portfolio of medicines to treat multiple sclerosis, has introduced
the first approved treatment for spinal muscular atrophy,
commercializes biosimilars of advanced biologics and is focused on
advancing research programs in multiple sclerosis and
neuroimmunology, neuromuscular disorders, movement disorders,
Alzheimer’s disease and dementia, ophthalmology, immunology,
neurocognitive disorders, acute neurology and pain.
We routinely post information that may be important to investors
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Biogen Safe Harbor Statement This news release
contains forward-looking statements, including statements made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, including statements about the
results of the Phase 2 LILAC study; the potential effects of
BIIB059; the potential benefits, safety and efficacy of BIIB059;
the clinical development program for BIIB059; the potential of our
commercial business and pipeline programs, including BIIB059; data
readouts and presentations related to BIIB059; the treatment of
autoimmune diseases; our strategy and plans; and risks and
uncertainties associated with drug development and
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“plan,” “possible,” “potential,” “will,” “would” and other words
and terms of similar meaning. Drug development and
commercialization involve a high degree of risk and only a small
number of research and development programs result in
commercialization of a product. Results in early stage clinical
trials may not be indicative of full results or results from later
stage or larger scale clinical trials and do not ensure regulatory
approval. You should not place undue reliance on these statements
or the scientific data presented.
These statements involve risks and uncertainties that could
cause actual results to differ materially from those reflected in
such statements, including without limitation risks relating to
uncertainty of success in the development and potential
commercialization of BIIB059; the occurrence of adverse safety
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