The New England Journal of Medicine Publishes Second Manuscript
Reporting Positive Phase 2 Results for Biogen’s Litifilimab
(BIIB059) in Lupus
Biogen Inc. (Nasdaq: BIIB) today announced that The New
England Journal of Medicine (NEJM) has published a second
manuscript detailing positive results from the company’s two-part
Phase 2 LILAC study, which evaluated litifilimab (also known as
BIIB059), an investigational drug, in systemic lupus erythematosus
(SLE) and cutaneous lupus erythematosus (CLE). Results from the SLE
portion of the study (Part A) published today show litifilimab met
the study’s primary endpoint by significantly reducing total active
joint count compared to placebo. Positive data from the CLE portion
of the study were published in NEJM on July 28th, 2022.
“Lupus is a debilitating autoimmune disease that causes chronic
inflammation, pain and organ damage, and predominantly affects
women and people of color,” said Richard Furie, M.D., The Marilyn
and Barry Rubenstein Chair in Rheumatology, Chief of the Division
of Rheumatology at Northwell Health and Professor at the Feinstein
Institutes for Medical Research. “Litifilimab has been shown to
inhibit the production of type I interferons as well as other
inflammatory mediators produced by plasmacytoid dendritic cells.
Strong evidence has accumulated that these mediators contribute to
disease activity in lupus.”
Biogen is currently enrolling participants into the Phase 3
TOPAZ-1 and TOPAZ-2 studies, which will evaluate the efficacy and
safety of litifilimab in participants with active SLE at 269
clinical trial sites worldwide. As part of Biogen’s commitment to
delivering diversity in its clinical trials, enrollment targets
have been set in the TOPAZ studies to achieve appropriate
representation of the African American and Hispanic/Latino
communities. Biogen also plans to initiate a pivotal study of
litifilimab in CLE in 2022.
“This second NEJM manuscript shows the totality of data from the
Phase 2 LILAC program, reinforcing our belief in the potential of
litifilimab as a first-in-class therapy for both systemic and
cutaneous lupus,” said Nathalie Franchimont, M.D., Ph.D., Head of
the Multiple Sclerosis and Immunology Development Unit at Biogen.
“At Biogen, our goal is to discover and develop new treatment
options that not only reduce lupus disease activity but also
decrease clinical manifestations that impact patients the most. We
look forward to continuing our evaluation of litifilimab in Phase 3
studies and sharing additional data when available.”
The Phase 2 LILAC Part A 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 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, 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.
In Part A of LILAC, litifilimab significantly reduced the total
number of swollen and tender joints in participants with SLE from
baseline compared to placebo over 24 weeks. This Phase 2 trial was
not powered to assess secondary endpoints.
In Part A, 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 diarrhea, nasopharyngitis, urinary tract
infection, fall and headache.
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). Binding of litifilimab to BDCA2 has been
shown to reduce production of pro-inflammatory molecules by pDCs,
including type-I interferon (IFN-I) as well as other cytokines and
chemokines.1,2 These pro-inflammatory mediators are thought to play
a major role in the pathogenesis of systemic and cutaneous
lupus.
About Systemic Lupus Erythematosus (SLE)SLE,
the systemic form of lupus, is a chronic autoimmune disease that
affects multiple organ systems with periods of illness or flares
alternating with periods of inactivity.3 SLE can present itself in
several ways including rash, arthritis, anemia, thrombocytopenia,
serositis, nephritis, seizures or psychosis.4 SLE is associated
with a greater risk of death from causes such as infection and
cardiovascular disease.
Lupus affects an estimated 5 million people worldwide.5 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.6-10 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
media - Twitter, LinkedIn, Facebook, YouTube.
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 and TOPAZ-2 studies; 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 and TOPAZ-2 studies or it will take longer
than expected; unexpected concerns that may arise from additional
data, analysis or results obtained during the TOPAZ-1 and TOPAZ-2
studies; 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. Monoclonal antibody
targeting BDCA2 ameliorates skin lesions in systemic lupus
erythematosus. J Clin Invest. 2019;129(3):1359-1371.
doi:10.1172/JCI124466
- Pellerin A, Otero K, Czerkowicz JM, et al. Anti-BDCA2
monoclonal antibody inhibits plasmacytoid dendritic cell activation
through Fc-dependent and Fc-independent mechanisms. EMBO Mol Med.
2015;7(4):464-476. doi:10.15252/emmm.201404719
- Tselios K, Gladman DD, Touma Z, Su J, Anderson N, Urowitz MB.
Disease course patterns in systemic lupus erythematosus. Lupus.
2019;28(1):114-122.
- Fanouriakis A, Tziolos N, Bertsias G, Boumpas DT. Update οn the
diagnosis and management of systemic lupus erythematosus. Ann
Rheum Dis. 2021;80(1):14-25.
doi:10.1136/annrheumdis-2020-218272
- Lupus Foundation of America. Lupus facts and statistics. Lupus
Foundation of America. 2016. Retrieved August 19, 2022, from
https://www.lupus.org/resources/lupus-facts-and-statistics
- 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 |
Biogen (TG:IDP)
Historical Stock Chart
From Jun 2024 to Jul 2024
Biogen (TG:IDP)
Historical Stock Chart
From Jul 2023 to Jul 2024