Biogen to Present Positive Phase 2 Systemic Lupus Erythematosus
Data at American College of Rheumatology 2020 Meeting
Today, Biogen Inc. (Nasdaq: BIIB) announced positive data from the
24-week systemic lupus erythematosus (SLE) portion of the Phase 2
LILAC study (part A) demonstrating that BIIB059 (anti-BDCA2) was
associated with a statistically significant reduction in total
active joint count. The study evaluated the efficacy and safety of
BIIB059, a humanized IgG1 monoclonal antibody (mAb) targeting blood
dendritic cell antigen 2 (BDCA2) expressed exclusively on
plasmacytoid dendritic cells. These data, along with the previously
reported findings from the cutaneous lupus erythematosus (CLE)
portion of the LILAC study, will be presented at the American
College of Rheumatology’s ACR Convergence 2020, being held
virtually from November 5-9, 2020.
“People living with systemic lupus erythematosus suffer from
chronic and debilitating symptoms that impact multiple organ
systems as well as their social and emotional well-being,” said
Nathalie Franchimont, M.D., Ph.D., Vice President and Head of the
Multiple Sclerosis and Immunology Development Unit at Biogen.
“These latest data highlight the potential of BIIB059 to impact
disease activity and, together with the earlier cutaneous lupus
erythematosus findings, reflect Biogen’s commitment to drive
therapeutic innovation for lupus patients who have limited
treatment options.”
The Phase 2 LILAC study (part A) met its primary endpoint of
reducing joint disease activity in individuals with SLE, as
measured by total active joint count. A statistically significant
difference in change from baseline of 3.4 in total active joint
count was observed at week 24 between participants who received
BIIB059 450 mg administered subcutaneously every 4 weeks with an
additional dose at week 2 versus placebo (p=0.037). Total active
joint count is the total number of tender or swollen joints. Tender
or swollen joints are one of the most common symptoms impacting
quality of life in people living with SLE.
The study also met the secondary endpoint of SLE Responder
Index-4 (SRI-4), resulting in an overall reduction in disease
activity in participants who received BIIB059 versus placebo. There
was a 26.35 percent higher SRI-4 response rate among participants
who received BIIB059 (56.77 percent) versus placebo (30.42 percent
[odds ratio=3.49, p=0.003]). The SRI-4 is a composite measure
comprising criteria from different internationally validated
indices of systemic disease activity.
An additional secondary endpoint from part A of the study in
individuals with SLE evaluated the effect of BIIB059 on skin
disease activity using the CLE Activity Disease Area and Severity
Index-Activity (CLASI-A) score in a subgroup of participants with a
baseline CLASI-A score of ≥8. There was a 20 percent higher
response rate among participants who received BIIB059 (69.10
percent) versus placebo (49.10 percent) who achieved at least 50
percent improvement (CLASI-50 response), however statistical
significance was not attained (odds ratio=2.51, p=0.064). CLASI-A
is a clinical tool that measures disease activity and damage in
CLE.
The majority of adverse events in the LILAC study were mild or
moderate. The incidence of serious adverse events was 5.3 percent
versus 10.7 percent in participants that received BIIB059 versus
placebo, respectively. Adverse events that led to drug
discontinuation were observed in two participants who received
BIIB059 and three participants who received placebo. Overall, the
efficacy, safety and tolerability results further support the
continued clinical development of BIIB059 in SLE.
Biogen Presentations Featured at ACR
Convergence 2020:
- Plenary presentation (Plenary Session II, abstract 0935):
Efficacy and Safety Results from a Phase 2, Randomized,
Double-Blind Trial of BIIB059, an Anti-Blood Dendritic Cell Antigen
2 Antibody, in SLE – Saturday, November 7, 11:45 am – 12:00 pm
Eastern Time (ET)
- Oral presentation (SLE – Treatment Session, abstract 0986):
BIIB059, a Humanized Monoclonal Antibody Binding to BDCA2 on
Plasmacytoid Dendritic Cells Shows Efficacy in a Phase 2 Study in
Participants with Active Cutaneous Lupus Erythematosus – Saturday,
November 7, 3:10 pm – 3:20 pm ET
About BIIB059BIIB059, discovered and developed
exclusively by Biogen, is a humanized IgG1 monoclonal antibody
(mAb) targeting blood dendritic cell antigen 2 (BDCA2) and is being
investigated for the treatment of cutaneous lupus erythematosus
(CLE) and systemic lupus erythematosus (SLE). BDCA2 is a receptor
that is exclusively 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. Biogen is currently
planning to initiate a Phase 3 program for BIIB059.
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 (part B) and in
individuals with systemic lupus erythematosus (SLE) with active
joint and skin manifestations (part A).
The SLE part of the study, which enrolled 132 patients,
evaluated a BIIB059 450 mg dose versus placebo injected
subcutaneously once every four weeks with an additional dose at
week 2 in individuals with active SLE. The primary endpoint was
change from baseline in total active joint count at Week 24.
About Systemic Lupus Erythematosus
(SLE) and Cutaneous Lupus
Erythematosus (CLE)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.
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. CLE may occur in the presence of, or more frequently, in
the absence of systemic 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, Alzheimer’s disease and dementia, neuromuscular
disorders, movement disorders, ophthalmology, immunology,
neurocognitive disorders, acute neurology and pain.
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contains forward-looking statements, including statements made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, about the results of the Phase 2
LILAC study of BIIB059; the potential clinical effects of BIIB059;
the potential benefits, safety and efficacy of BIIB059; the
clinical development program for BIIB059; the potential of our
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