Biogen Inc. (Nasdaq: BIIB) today announced that The New England
Journal of Medicine (NEJM) has published positive results from the
cutaneous lupus erythematosus (CLE) portion of the two-part Phase 2
LILAC study (Part B) evaluating litifilimab (known as BIIB059), an
investigational drug for the treatment of lupus. Litifilimab met
its primary endpoint by demonstrating superior efficacy to placebo
in reducing skin disease activity.
“CLE can have a lasting negative impact on skin symptoms and
emotional aspects of people’s lives, leading to a debilitating
impact on quality of life and irreversible skin damage,” said
Victoria Werth, M.S., M.D., Professor of Dermatology at the
University of Pennsylvania’s Perelman School of Medicine. “Despite
advancements over the past two decades, CLE represents a high unmet
medical need with no cure. The LILAC study is among the first
randomized controlled trials in CLE and I am encouraged by the
publication of these positive results in NEJM.”
Biogen has progressed litifilimab to late-stage development and
is actively enrolling participants with systemic lupus
erythematosus into the Phase 3 TOPAZ-1 and TOPAZ-2 studies, with
plans to initiate a pivotal study in CLE this year. Litifilimab has
a novel mechanism of action that engages blood dendritic cell
antigen 2 (BDCA2), a receptor solely expressed on the surface of
plasmacytoid dendritic cells, resulting in decreased production of
type 1 interferons, cytokines and chemokines at the site of
inflammation such as the skin.1
“Litifilimab was developed by Biogen scientists as a potential
first-in-class therapy for lupus,” said Nathalie Franchimont, M.D.,
Ph.D., Head of the Multiple Sclerosis and Immunology Development
Unit at Biogen. “These Phase 2 data underscore our goal of
delivering meaningful new therapies to people with cutaneous lupus,
an autoimmune disease affecting the skin that can occur with or
without impacting other organs, who currently have limited
treatment options. We are excited to progress this promising
candidate into late-stage development to further evaluate its
potential, particularly in those who historically have been
underserved.”
The Phase 2 LILAC Part B ResultsLILAC was a
randomized, double-blind, placebo-controlled study that evaluated
the efficacy and safety of litifilimab versus placebo in two parts:
Part A in participants who had systemic lupus erythematosus (SLE)
with active joint and skin manifestations; and Part B in
participants with moderate-to-severe active CLE, including active
subacute and chronic subtypes, with or without systemic
manifestations. As previously reported,2,3 both Part A and Part B
of the study met their respective primary endpoints, with
litifilimab demonstrating superior efficacy to placebo in reducing
total active joint count and improving skin disease activity in
participants with SLE and CLE, respectively.
Part B of the LILAC study assessed multiple doses of litifilimab
or placebo in participants with active, histologically confirmed
CLE. The primary analysis included a test of dose-response to
assess whether there was a response across the four dose groups
(placebo, 50, 150, or 450 mg litifilimab, administered
subcutaneously at weeks 0, 2, 4, 8, and 12) on the basis of the
primary endpoint of skin disease activity. This Phase 2 trial was
not powered to assess secondary endpoints.
The LILAC study population in Part B was representative of the
broader CLE patient population, with approximately 10 percent of
participants who reported race and ethnicity identifying as Black
or African American. In Part B, litifilimab demonstrated a
significant dose-response relationship based on the percent change
from baseline in the Cutaneous Lupus Erythematosus Disease Area and
Severity Index (CLASI-A) score (primary endpoint), a measure of
skin disease activity, at Week 16.
In Part B, litifilimab was generally well tolerated, with most
reported adverse events (AEs) rated as mild or moderate. The most
common AEs reported in ≥5% of participants in the pooled
litifilimab groups were nasopharyngitis, headache, injection-site
erythema, SLE, arthralgia, upper respiratory tract infection,
influenza, pruritus, and cough.
Detailed findings for Part A of LILAC, which enrolled
participants with SLE with active joint and skin manifestations,
will be published separately in a peer-reviewed journal.
About Litifilimab
(BIIB059)Litifilimab (known as BIIB059),
discovered and developed in-house by Biogen scientists, is a
humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic
cell antigen 2 (BDCA2) and is being investigated for the potential
treatment of systemic lupus erythematosus (SLE) and cutaneous lupus
erythematosus (CLE). 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 production from pDCs, including type-I IFN (IFN-I) as
well as other cytokines and chemokines. These inflammatory
mediators are thought to play a major role in the pathogenesis of
systemic and cutaneous lupus.
About Cutaneous Lupus Erythematosus (CLE)CLE, a
type of lupus, is a chronic autoimmune skin disease that can occur
with or without systemic manifestations; people with CLE frequently
experience symptoms including rash, pain, pruritis (itch) and
photosensitivity as well as skin damage that may worsen over time
and can include irreversible scarring alopecia and dyspigmentation
that can be disfiguring and substantially impact quality of
life.4-7
Although anyone can develop lupus, an estimated 90 percent of
people living with lupus are women; most begin to see symptoms
between the ages of 15-40.6 The disease disproportionately impacts
diverse ethno-racial groups, including African American, Asian,
American Indian/Alaskan Native and Hispanic/Latino communities.9-12
There is currently no cure for lupus.
Decades of study by Biogen on pathways at the intersection of
neurology and immunology provide the company with expertise in
specialized immunology. Biogen is advancing two lupus therapies in
Phase 3 trials. Dapirolizumab pegol is being developed in
collaboration with UCB for systemic lupus erythematosus (SLE). The
second, litifilimab (BIIB059), was fully developed in-house at
Biogen and is now in Phase 3 for SLE, with plans for further study
in CLE.
About BiogenAs pioneers in neuroscience, Biogen
discovers, develops, and delivers worldwide innovative therapies
for people living with serious neurological 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, Sir Kenneth Murray, and Nobel Prize
winners Walter Gilbert and Phillip Sharp. Today, Biogen has a
leading portfolio of medicines to treat multiple sclerosis, has
introduced the first approved treatment for spinal muscular
atrophy, and developed the first and only approved treatment to
address a defining pathology of Alzheimer’s disease. Biogen is also
commercializing biosimilars and focusing on advancing one of the
industry’s most diversified pipelines in neuroscience that will
transform the standard of care for patients in several areas of
high unmet need.
In 2020, Biogen launched a bold 20-year, $250 million initiative
to address the deeply interrelated issues of climate, health, and
equity. Healthy Climate, Healthy Lives™ aims to eliminate fossil
fuels across the company’s operations, build collaborations with
renowned institutions to advance the science to improve human
health outcomes, and support underserved communities.
We routinely post information that may be important to investors
on our website at www.biogen.com. Follow us on social
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Biogen Safe Harbor 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, about the potential benefits, safety and
efficacy of BIIB059; the results of the Phase 2 LILAC study; the
identification and treatment of lupus, SLE and CLE; our research
and development program for the treatment of lupus, SLE and CLE;
the clinical development program for BIIB059; the design and
enrollment of the TOPAZ-1 study; risks and uncertainties associated
with drug development and commercialization; and the potential of
our pipeline programs, including BIIB059 and dapirolizumab pegol.
These statements may be identified by words such as “aim,”
“anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,”
“goal,” “intend,” “may,” “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 that we may not
fully enroll the TOPAZ-1 study or it will take longer than
expected; unexpected concerns that may arise from additional data,
analysis or results obtained during the TOPAZ-1 study; the
occurrence of adverse safety events; risks of unexpected costs or
delays; the risks of other unexpected hurdles; failure to protect
and enforce our data, intellectual property and other proprietary
rights and uncertainties relating to intellectual property claims
and challenges; regulatory authorities may require additional
information or further studies; product liability claims; third
party collaboration risks; and the direct and indirect impacts of
the ongoing COVID-19 pandemic on our business, results of
operations and financial condition. The foregoing sets forth many,
but not all, of the factors that could cause actual results to
differ from our expectations in any forward-looking statement.
Investors should consider this cautionary statement as well as the
risk factors identified in our most recent annual or quarterly
report and in other reports we have filed with the U.S. Securities
and Exchange Commission. These statements are based on our current
beliefs and expectations and speak only as of the date of this news
release. We do not undertake any obligation to publicly update any
forward-looking statements, whether as a result of new information,
future developments or otherwise.
References:
- Furie R, Werth VP, Merola JF, et al (2019). Monoclonal antibody
targeting BDCA2 ameliorates skin lesions in systemic lupus
erythematosus. J Clin Invest. 129:1359–1371.
- Furie R, et al. Efficacy and Safety Results from a Phase 2,
Randomized, Double-Blind Trial of BIIB059, an Anti-Blood Dendritic
Cell Antigen 2 Antibody, in SLE [abstract]. Arthritis
Rheumatol. 2020; 72 (suppl 10).
https://acrabstracts.org/abstract/efficacy-and-safety-results-from-a-phase-2-randomized-double-blind-trial-of-biib059-an-anti-blood-dendritic-cell-antigen-2-antibody-in-sle/.
- Werth V, et al. BIIB059, a Humanized Monoclonal Antibody
Targeting Blood Dendritic Cell Antigen 2 on Plasmacytoid Dendritic
Cells, Shows Dose-Related Efficacy in a Phase 2 Study in
Participants with Active Cutaneous Lupus Erythematosus
[abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10).
https://acrabstracts.org/abstract/biib059-a-humanized-monoclonal-antibody-targeting-blood-dendritic-cell-antigen-2-on-plasmacytoid-dendritic-cells-shows-dose-related-efficacy-in-a-phase-2-study-in-participants-with-active-cutaneous/.
- Ogunsanya ME, Brown CM, Lin D, et al (2018). Understanding the
disease burden and unmet needs among patients with cutaneous lupus
erythematosus: A qualitative study. Int J Womens Dermatol.
4(3):152-158.
- Ogunsanya ME, Cho SK, Hudson A, Chong, BF (2019). Validation
and reliability of a disease-specific quality of life measure in
patients with cutaneous lupus erythematosus. Br J Dermatol.
180(6):1430-1437.
- Méndez-Flores S, Orozco-Topete R, Bermúdez-Bermejo
P, Hernández-Molina G (2013). Pain and pruritus in cutaneous
lupus: their association with dermatologic quality of life and
disease activity. Clin Exp Rheumatol. 31(6):940-942.
- Foering K, Chang AY, Piette EW, et al (2013). Characterization
of clinical photosensitivity in cutaneous lupus erythematosus. J Am
Acad Dermatol. 69(2):205-213.
- Pons-Estel GJ, Ugarte-Gil MF, Alarcón GS (2017). Epidemiology
of systemic lupus erythematosus. Expert Rev Clin Immunol.
13(8):799-814.
- Izmirly PM, Parton H, Wang L, et al (2021). Prevalence of
systemic lupus erythematosus in the United States: Estimates from a
meta-analysis of the Centers for Disease Control and Prevention
National Lupus Registries. Arthritis Rheumatol. 73(6):991-996.
- Lim SS, Helmick CG, Bao G, et al (2019). Racial disparities in
mortality associated with systemic lupus erythematosus - Fulton and
DeKalb Counties, Georgia, 2002-2016. MMWR Morb Mortal Wkly Rep.
68(18):419-422.
- Rees F, Doherty M, Grainge MJ, et al (2017). The worldwide
incidence and prevalence of systemic lupus erythematosus: a
systematic review of epidemiological studies. Rheumatology
(Oxford). 56(11):1945-1961.
- Drenkard C, Lim SS (2019). Update on lupus epidemiology:
advancing health disparities research through the study of minority
populations. Curr Opin Rheumatol. 31(6):689-696.
MEDIA CONTACT:Ashleigh Koss+ 1 908 205
2572public.affairs@biogen.com |
INVESTOR CONTACT:Mike Hencke+1 781 464 2442IR@biogen.com |
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