Biogen Presents Positive Phase 2 Cutaneous Lupus Erythematosus
(CLE) Data at European E-Congress of Rheumatology (EULAR) 2020
Today, Biogen Inc. (Nasdaq: BIIB) shared positive data from
the 16-week cutaneous lupus erythematosus (CLE) portion of the
Phase 2 LILAC study. The study evaluated 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 (pDCs). The data were presented at the European
E-Congress of Rheumatology (EULAR) 2020, being held virtually from
June 3-6, 2020.
“We are encouraged by the CLE results from the BIIB059 Phase 2
lupus study presented at the 2020 virtual EULAR congress,” said
Nathalie Franchimont, M.D., Ph.D., vice president of the multiple
sclerosis and immunology development unit at Biogen. “These data
underscore our goal of delivering meaningful new therapies to
people living with lupus, who currently have limited treatment
options.”
The CLE part of the LILAC 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 people with CLE. Study participants with CLE that received 50
mg, 150 mg and 450 mg of BIIB059 experienced reductions in CLASI-A
scores of 38.8 percent (p=0.015), 47.9 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 change in CLE skin disease
activity.
With respect to the secondary endpoint of CLASI-50 response,
statistical significance was achieved in study participants who
received 450 mg of BIIB059; 23.3 percent (p=0.024) more
participants achieved CLASI-50 response versus placebo. While not
statistically significant, more participants treated with BIIB059
50 mg (15.8 percent) and 150 mg (21.2 percent) achieved a CLASI-50
response versus placebo. A CLASI-50 response is defined as a 50
percent improvement from baseline in CLASI-A score.
The majority of adverse events in the LILAC study were mild or
moderate and the incidence of serious adverse events was 7.1
percent versus 9.1 percent in participants that received BIIB059
versus placebo. Rate of infections was 34.3 percent versus 30.3
percent in participants that received BIIB059 versus those given
placebo; no significant increased risk of infection has been
identified. Eight participants, who all received BIIB059,
discontinued study drug due to side effects. Overall, the safety
and tolerability results further support the continued development
of BIIB059.
LILAC was a randomized, parallel, double-blind,
placebo-controlled two-part study that evaluated BIIB059 versus
placebo in participants with active CLE, including chronic and
subacute subtypes, with or without systemic manifestations and in
participants with systemic lupus erythematosus (SLE) with active
joint and skin manifestations.
Final results from the SLE part of the LILAC study will be
presented at a future medical congress.
About BIIB059BIIB059, discovered and developed
exclusively by Biogen, is an investigational fully humanized IgG1
monoclonal antibody (mAb) targeting blood dendritic cell antigen 2
(BDCA2) currently being evaluated 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 (NCT02847598) was a randomized, parallel, double-blind,
placebo-controlled two-part study that enrolled 264 participants to
evaluate the safety and efficacy of BIIB059 versus placebo in
participants with active CLE, including chronic and subacute
subtypes, with or without systemic manifestations and in
participants with SLE with active joint and skin
manifestations.
The CLE part of the study, which enrolled 132 participants,
investigated either a BIIB059 50 mg, 150 mg or 450 mg dose
administered subcutaneously every 4 weeks with an additional dose
at week 2 versus placebo in participants with active CLE. The
primary endpoint was dose-response of BIIB059 as measured by
percent change from baseline in the CLASI-A Score at Week 16.
About Cutaneous Lupus Erythematosus (CLE) 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 of the chronic
forms of the disease, people may experience scarring, skin atrophy
and alopecia.
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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