Denali Therapeutics Announces Upcoming Presentations on EIF2B Activator DNL343 and RIPK1 Inhibitor SAR443820/DNL788 at the 2021 Annual Northeast Amyotrophic Lateral Sclerosis (NEALS) Meeting
September 29 2021 - 8:00AM
Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical
company developing a broad portfolio of product candidates
engineered to cross the blood-brain barrier (BBB) for
neurodegenerative diseases, today announced upcoming presentations
at the 2021 Annual Northeast Amyotrophic Lateral Sclerosis (NEALS)
Meeting being held virtually, October 6-7.
Denali will present preclinical and clinical data including
results from a Phase 1 healthy volunteer study of its CNS-penetrant
EIF2B activator DNL343, which is currently under investigation in a
Phase 1b study in participants with ALS. Denali’s partner Sanofi
will present plans for a Phase 2 study in participants with ALS,
with the CNS-penetrant RIPK1 inhibitor SAR443820, which completed
investigation in a Phase 1 study in healthy volunteers.
Presentations at NEALS
Title: The EIF2B Agonist DNL343 Modulates the
Integrated Stress Response: Results from the EIF2B R191H Mouse
Model and a Phase 1 Study in Healthy
VolunteersDate: Wednesday, October 6,
2021Time: 4:00-5:00 p.m. Eastern Time
Title: A Phase 2, Multi-Center, Randomized,
Double-Blind, Placebo-Controlled Study, Followed by an Open-Label
Long-Term Extension, to Evaluate the Efficacy and Safety of
SAR443820 in Adult Participants with Amyotrophic Lateral
SclerosisDate: Thursday, October 7,
2021Time: 4:00-5:00 p.m. Eastern Time
About DNL343
Modulation of EIF2B activity with DNL343 is a novel and targeted
investigational approach with first-in-class potential for the
treatment of ALS. EIF2B is an intracellular protein complex that
regulates protein synthesis and is required for neuronal health and
function. When neurons experience stress, as occurs in ALS, EIF2B
activity is suppressed. This leads to impaired protein synthesis
and results in the formation of "stress granules," which are
thought to be a precursor of TDP-43 aggregation, a hallmark
pathology in ALS. DNL343 is designed to activate EIF2B and thereby
restore protein synthesis, disperse TDP-43 aggregates, and improve
neuronal survival.
Denali is conducting a multicenter, randomized,
placebo-controlled, double-blind, 28-day study followed by an
18-month open-label extension, designed to evaluate the safety,
pharmacokinetics, and pharmacodynamics of DNL343 in participants
with ALS. Further information on the Phase 1b study (study number
NCT05006352) can be accessed on the ClinicalTrials.gov website or
by clicking here.
About SAR443820/DNL788
SAR443820/DNL788 is a novel, CNS-penetrant, small molecule
inhibitor of RIPK1, a critical signaling mediator of necroptotic
cell death, cytokine release, and inflammatory pathways. Denali and
Sanofi entered into a broad collaboration in October 2018 for the
global development and commercialization of RIPK1 inhibitors. This
includes CNS-penetrant molecules such as SAR443820/DNL788, which
was evaluated in a Phase 1 study in healthy volunteers, with
potential development for neurological indications such as ALS,
multiple sclerosis (MS) and Alzheimer’s disease (AD).
Denali Webinar for Analysts and Investors on October 6,
2021
Denali plans to host a webinar for analysts and investors to
highlight development programs in ALS and frontotemporal dementia
(FTD) on October 6, starting at approximately 4:30 p.m. Eastern
Time. During the webinar, Denali will review the NEALS
presentations related to its investigational small molecule
therapeutics DNL343 and SAR443820. Denali will also review
preclinical data on PTV:PGRN, its Transport Vehicle (TV)-enabled
biotherapeutic in development for FTD-GRN, which was recently
published in Cell. The webinar will be available on Denali’s
corporate website on the Events page under the Investor section at
https://www.denalitherapeutics.com/investors/events. An archived
replay of the webinar will be available for at least 30 days
following the event. Preregistration for the webinar can be
accessed here.
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.
Cautionary Note Regarding Forward-Looking
Statements
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, business plans, business strategy, product
candidates, expected milestones, planned preclinical studies and
clinical trials and presentations of data from such trials,
timelines and expectations related to DNL343, including the
potential for the treatment of amyotrophic lateral sclerosis (ALS),
and timelines and expectations related to DNL788 and its potential
for the treatment of ALS and other neurological conditions. 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 collaboration agreements; Denali’s early
stages of clinical drug development; Denali’s and its partners’
ability to complete the development and, if approved,
commercialization of its product candidates; Denali’s reliance on
third parties for the manufacture and supply of its product
candidates for clinical trials; Denali’s and it's partners' ability
to conduct or complete clinical trials on expected timelines; the
uncertainty that product candidates will receive regulatory
approval necessary to be commercialized; Denali’s ability to
continue to create a pipeline of product candidates or develop
commercially successful products; 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, including those described in Denali’s
most recent Quarterly Report on Form 10-Q filed with the Securities
and Exchange Commission (SEC) on August 4, 2021, Denali’s Annual
Report on Form 10-K filed with the SEC on February 26, 2021, and
Denali’s future reports to be filed with the SEC. The
forward-looking statements in this press release are based on
information available to Denali as of the date hereof. Denali
disclaims any obligation to update any forward-looking statements,
except as required by law.
Investor Relations Contact: |
Media Contacts: |
|
Laura Hansen, Ph.D.Vice
President, Investor Relations(650) 452-2747hansen@dnli.com |
Lizzie Hyland(646)
495-2706lizzie.hyland@fgh.comorMorgan Warners(202)
295-0124morgan.warners@fgh.com |
|
Denali Therapeutics (NASDAQ:DNLI)
Historical Stock Chart
From Jun 2024 to Jul 2024
Denali Therapeutics (NASDAQ:DNLI)
Historical Stock Chart
From Jul 2023 to Jul 2024