Denali Therapeutics Inc. (NASDAQ: DNLI), and Biogen Inc.
(NASDAQ:BIIB) today announced that dosing has commenced in the
global Phase 2b LUMA study to evaluate the efficacy and safety of
BIIB122 (DNL151), as compared to placebo in approximately 640
participants with early-stage Parkinson’s disease.
LUMA is a Phase 2b multi-center, randomized, double-blind,
placebo-controlled study to evaluate safety and efficacy of BIIB122
in people with early-stage Parkinson’s disease between the ages of
30 and 80. The primary endpoint of LUMA is Time to Confirmed
Worsening in Movement Disorder Society Unified Parkinson's Disease
Rating Scale (MDS-UPDRS) parts II and III combined score over the
treatment period. Participants will be randomized to receive oral
BIIB122 or placebo once daily.
“More than 10 million people worldwide are affected by
Parkinson’s disease, and there is a significant medical need for
therapies to slow or stop the progression of this devastating
neurodegenerative disease,” said Carole Ho, M.D., Chief Medical
Officer at Denali. “Initiation of the LUMA study marks an important
milestone in the development of BIIB122 as a potentially
first-in-class oral LRRK2 therapy for Parkinson’s disease. We look
forward to continuing our collaboration with Biogen and the
Parkinson’s community in our unified goal to develop BIIB122 as a
potential treatment option for people and families living with
Parkinson’s disease.”
BIIB122 is an investigational small molecule inhibitor of LRRK2
that was discovered and developed by Denali. Denali and Biogen are
co-developing and co-commercializing BIIB122 for the potential
treatment of Parkinson’s disease. The BIIB122 clinical development
program includes both the LUMA Phase 2b study and the Phase 3
LIGHTHOUSE study in individuals with Parkinson’s disease with LRRK2
pathogenic variants.
“Inhibition of LRRK2 is a novel approach designed to target an
underlying biological pathway implicated in Parkinson’s disease,”
said Samantha Budd Haeberlein, Ph.D., Senior Vice President, Head
of Neurodegeneration Development at Biogen. “Together, Biogen and
Denali have designed a rigorous development program to evaluate
BIIB122 in patients with and without LRRK2 mutations. With the LUMA
study now underway and the LIGHTHOUSE study planned to initiate
this year, we have the opportunity to advance BIIB122 for the
treatment of Parkinson’s disease, a progressive neurodegenerative
disease with high unmet need.”
Further information about LUMA (NCT05348785) can be accessed at
clinicaltrials.gov.
About LRRK2 and BIIB122Following discovery of
the LRRK2 mutation as a pathogenic genetic factor for Parkinson’s
disease, further research has uncovered that it has the potential
to be a novel therapeutic target for Parkinson’s disease. Mutations
in leucine-rich repeat kinase 2 (LRRK2) account for 4-5% of
familial and 1-2% of sporadic Parkinson’s disease.1, 2
BIIB122 is a selective, central nervous system-penetrant small
molecule inhibitor of LRRK2 that is hypothesized to improve
lysosomal dysfunction. BIIB122 is an investigational drug that is
not approved by any regulatory authority, and its safety and
efficacy have not been established.
About Denali Therapeutics Denali
Therapeutics is a biopharmaceutical company developing a broad
portfolio of product candidates engineered to cross the blood-brain
barrier (BBB) for neurodegenerative diseases. Denali pursues new
treatments by rigorously assessing genetically validated targets,
engineering delivery across the BBB and guiding development through
biomarkers that demonstrate target and pathway engagement. Denali
is based in South San Francisco. For additional information, please
visit www.denalitherapeutics.com.
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 is providing the first and only approved treatment to
address a defining pathology of Alzheimer’s disease. Biogen is also
commercializing biosimilars and focusing on advancing the
industry’s most diversified pipeline 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. The company routinely posts information that may
be important to investors on our website at www.biogen.com. To
learn more, please visit www.biogen.com and follow Biogen
on social media
– Twitter, LinkedIn, Facebook, YouTube.
Denali Safe Harbor This press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Forward-looking
statements expressed or implied in this press release include, but
are not limited to, statements regarding Denali's progress and
business plans; plans, timelines, and expectations related to
BIIB122 (DNL151), including with respect to the ongoing Phase 2b
LUMA study and the timing and expectations of the planned Phase 3
LIGHTHOUSE study; the potential of BIIB122 (DNL151) to be a
treatment for Parkinson’s disease and a first-in-class oral
therapy; the potential for LRRK2 inhibition to slow the progression
of Parkinson's disease in certain patients; the potential benefits
and likelihood of success of, activity under, and expectations
related to Denali’s collaboration with Biogen; and statements made
by Denali’s Chief Medical Officer and Biogen’s Senior Vice
President, Global Safety & Regulatory Sciences. Actual results
are subject to risks and uncertainties and may differ materially
from those indicated by these forward-looking statements as a
result of these risks and uncertainties, including but not limited
to, risks related to: any and all risks to Denali’s business and
operations caused directly or indirectly by the evolving COVID-19
pandemic; risk of the occurrence of any event, change or other
circumstance that could give rise to the termination of Denali’s
agreements with Biogen; Denali’s early stages of clinical drug
development; Denali’s and Biogen’s ability to advance and complete
the development of BIIB122 (DNL151); Denali’s and Biogen’s ability
to initiate, enroll patients in, conduct, and complete the planned
clinical trials of BIIB122 (DNL151) on expected timelines; Denali’s
reliance on third parties for the manufacture and supply of its
product candidates for clinical trials; Denali’s dependence on
successful development of its blood-brain barrier platform
technology and its current programs and product candidates; the
potential for the planned clinical trials of BIIB122 (DNL151) to
differ from preclinical, early clinical, preliminary or expected
results; the risk of significant adverse events, toxicities or
other undesirable side effects; the uncertainty that product
candidates will receive regulatory approval necessary to be
commercialized; Denali’s ability to obtain, maintain, or protect
intellectual property rights related to its product candidates;
implementation of Denali’s strategic plans for its business,
product candidates and blood-brain barrier platform technology; and
other risks. In light of these risks, uncertainties, and
assumptions, the forward-looking statements in this press release
are inherently uncertain and may not occur, and actual results
could differ materially and adversely from those anticipated or
implied in the forward-looking statements. Accordingly, you should
not rely upon forward-looking statements as predictions of future
events. Information regarding additional risks and uncertainties
may be found in Denali’s Annual and Quarterly Reports filed on
Forms 10-K and 10Q filed with the Securities and Exchange
Commission (SEC) on February 28, 2022 and May 5, 2022,
respectively, and Denali’s future reports to be filed with the SEC.
Denali does not undertake any obligation to update or revise any
forward-looking statements, to conform these statements to actual
results or to make changes in Denali’s expectations, except as
required by law.
Biogen Safe HarborThis press release contains
forward-looking statements, made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995,
including statements relating to the potential benefits and results
that may be achieved through Biogen’s collaboration with Denali;
the potential benefits, safety and efficacy of BIIB122 (DNL151) and
other LRRK2 inhibitor molecules; the clinical development program
for BIIB122 (DNL151) and other LRRK2 inhibitor molecules; the
potential benefits of Denali’s TV technology platform and TV
programs including its ATV: anti-amyloid beta program; the
treatment of Parkinson’s disease; the potential of Biogen’s
commercial business and pipeline programs; Biogen’s strategy and
plans; the potential treatment of neurological and
neurodegenerative diseases; and risks and uncertainties associated
with drug development and commercialization. These forward-looking
statements may be accompanied by words such as “aim,” “anticipate,”
“believe,” “could,” “estimate,” “expect,” “forecast,” “goal,”
“intend,” “may,” “plan,” “potential,” “possible,” “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 the
proposed transaction will be completed in a timely manner or at
all; the possibility that certain closing conditions to the
proposed transaction will not be satisfied; uncertainty as to
whether the anticipated benefits of the proposed collaboration can
be achieved; risks of unexpected hurdles, costs or delays;
uncertainty of success in the development and potential
commercialization of BIIB122 (DNL151) and other undisclosed
neurological targets, which may be impacted by, among other things,
unexpected concerns that may arise from additional data or
analysis, the occurrence of adverse safety events, failure to
obtain regulatory approvals in certain jurisdictions, failure to
protect and enforce Biogen’s data, intellectual property and other
proprietary rights and uncertainties relating to intellectual
property claims and challenges; product liability claims; third
party collaboration risks; and the direct and indirect impacts of
the ongoing COVID-19 pandemic on Biogen’s 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 Biogen’s expectations in any forward-looking statement.
Investors should consider this cautionary statement, as well as the
risks factors identified in Biogen’s most recent annual or
quarterly report and in other reports Biogen has filed with the
U.S. Securities and Exchange Commission. These statements are based
on Biogen’s current beliefs and expectations and speak only as of
the date of this press release. Biogen does not undertake any
obligation to publicly update any forward-looking statements,
whether as a result of new information, future developments or
otherwise.
MEDIA CONTACTS:dna
Communications Angela Salerno-RobinSenior Vice President,
Media Relations, Healthcare+ 1 212 445
8219Asalerno-robin@dna-comms.comBiogenAshleigh
Koss+ 1 908 205 2572public.affairs@biogen.com |
INVESTOR
CONTACT: Denali TherapeuticsLaura Hansen,
Ph.D. Vice President, Investor Relations + 1 650 452
2747 hansen@dnli.com BiogenMike Hencke+1
781 464 2442IR@biogen.com |
1 Healy DG, Falchi M, O'Sullivan SS, et al. Phenotype, genotype,
and worldwide genetic penetrance of LRRK2-associated Parkinson's
disease: a case-control study. Lancet Neurol. 2008;7(7):583-90.2
Hernandez DG, Reed X, Singleton AB. Genetics in Parkinson disease:
Mendelian versus non-Mendelian inheritance. J Neurochem. 2016;139
Suppl 1:59-74. Epub 2016/04/18
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