Biogen Announces First Patient Dosed in Phase 3 Systemic Lupus
Erythematosus Study
Biogen Inc. (Nasdaq: BIIB) today announced that the first patient
has been dosed in the global clinical study, TOPAZ-1. The Phase 3
study will evaluate the clinical efficacy and assess the safety of
BIIB059, a first in-class, humanized IgG1 monoclonal antibody (mAb)
targeting blood dendritic cell antigen 2 (BDCA2), as compared to
placebo, in participants with active systemic lupus erythematosus
(SLE). TOPAZ-1 is expected to be conducted at approximately 135
sites worldwide and aims to enroll 540 adults with active SLE.
“A chronic autoimmune condition such as lupus, which
overwhelmingly affects women, has a tremendous impact on my
patients’ daily lives, including their physical, mental and social
wellbeing,” said Richard Furie, M.D., Chief of the Division of
Rheumatology at Northwell Health and Professor at Zucker School of
Medicine at Hofstra/Northwell. “There remains a significant need
for efficacious and generally safe treatment options for lupus
patients. Based on the positive results observed in the Phase 2
LILAC study, we are excited to continue to evaluate the potential
of BIIB059 in TOPAZ-1.”
TOPAZ-1 is a 52-week, multicenter, randomized double-blind,
placebo-controlled Phase 3 study to evaluate the efficacy and
safety of BIIB059 compared with placebo. Participants will be
randomized to receive subcutaneous treatment with BIIB059 at one of
two doses or placebo every four weeks with an additional dose at
Week 2, in addition to their existing lupus therapy.
“We look forward to working with the lupus community as we
advance the clinical development of BIIB059 with the hope of
bringing a meaningful new treatment option to people living with
systemic and cutaneous lupus,” said Nathalie Franchimont, M.D.,
Ph.D., Head of the Multiple Sclerosis and Immunology Development
Unit at Biogen. “Additionally, we are reinforcing Biogen’s
commitment to the inclusion of underrepresented groups in our
clinical trials. We have set enrollment targets that reflect the
prevalence of SLE in African-American and Hispanic/Latinx
communities with the aim to achieve appropriate representation in
the TOPAZ-1 study.”
The primary objective of TOPAZ-1 is to demonstrate reduction in
disease activity as measured with the primary endpoint, proportion
of participants who achieve an SLE Responder Index-4 (SRI-4)
response at Week 52. SRI is a composite index using validated
indices to measure global and organ-/system-specific disease
activity. Key secondary endpoints will evaluate the effect of
BIIB059 on additional efficacy parameters including proportion of
patients achieving SRI-4 response at Week 24, oral corticosteroid
use, organ-specific disease activity (joint and/or skin) and flare
rates. Safety will be evaluated throughout the study duration.
The initiation of the TOPAZ-1 study is based on the results from
the Phase 2 LILAC study. In LILAC, BIIB059 met its primary
endpoint, demonstrating statistically significant reduction of
disease activity in patients with SLE. The majority of adverse
events in the LILAC study were mild or moderate.
More information on the TOPAZ-1 study (NCT04895241) is available
at clinicaltrials.gov.
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 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 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 Systemic Lupus Erythematosus (SLE) 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. There are an
estimated four million people worldwide impacted by SLE.i
Although anyone can develop lupus, an estimated ninety percent
of people living with lupus are women; most begin to see symptoms
between the ages of 15-40.ii The disease disproportionately impacts
certain ethno-racial groups, including African American, Asian,
American Indian/Alaskan Native and Hispanic/Latinx
communities.iii,iv,v,vi There is currently no cure for lupus.
Biogen is advancing two investigational lupus assets in Phase 3
studies: BIIB059, an anti-BDCA2, and dapirolizumab pegol, an
anti-CD40L being developed in collaboration with UCB, which began a
Phase 3 trial in 2020.
About BiogenAt 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, neuropsychiatry,
immunology, acute neurology and neuropathic 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, 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.
MEDIA CONTACT:Allison Parks+1 781 464
3260public.affairs@biogen.com |
INVESTOR CONTACT:Mike Hencke+1 781 464 2442IR@biogen.com |
i Data on file. Estimated by Biogen epidemiology 2015ii
Pons-Estel GJ, Ugarte-Gil MF, Alarcón GS. Epidemiology of systemic
lupus erythematosus. Expert Rev Clin Immunol. 2017
Aug;13(8):799-814.iii Izmirly PM, Parton H, Wang L, et al.
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.
2021;73(6):991-996.iv Lim SS, Helmick CG, Bao G, et al. Racial
Disparities in Mortality Associated with Systemic Lupus
Erythematosus - Fulton and DeKalb Counties, Georgia,
2002-2016. MMWR Morb Mortal Wkly Rep. 2019;68(18):419-422.v
Rees F, Doherty M, Grainge MJ, Lanyon P, Zhang W. The worldwide
incidence and prevalence of systemic lupus erythematosus: a
systematic review of epidemiological studies. Rheumatology
(Oxford). 2017;56(11):1945-1961.vi Drenkard C, Lim SS. Update on
lupus epidemiology: advancing health disparities research through
the study of minority populations. Curr Opin Rheumatol.
2019;31(6):689-696.
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