Denali Therapeutics Announces That Its Partner Sanofi has Commenced Dosing of DNL758 in a Phase 1 Study
August 05 2019 - 8:00AM
Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical
company developing a broad portfolio of product candidates for
neurodegenerative diseases, today announced that its partner Sanofi
has commenced dosing of DNL758, a peripherally restricted small
molecule inhibitor of RIPK1, in a Phase 1 healthy volunteer study.
This triggers a milestone payment of $10 million to Denali
according to the Sanofi Collaboration Agreement for RIPK1
inhibitors.
RIPK1, receptor-interacting serine/threonine-protein kinase 1,
is a critical signaling protein in the TNF receptor pathway, which
regulates inflammation and cell death in tissues throughout the
body. Denali and Sanofi are developing several molecules targeting
RIPK1 inhibition, including DNL747 in neurological indications and
DNL758 in several non-neurological indications.
“We believe that inhibition of RIPK1, a known target in the TNF
pathway, has a compelling scientific rationale in autoimmune
diseases," said Ryan Watts, Ph.D., CEO. “While Denali will remain
focused on defeating neurodegeneration, we are thrilled that our
partner Sanofi has commenced clinical studies with DNL758, to
investigate its potential in peripheral diseases.”
About Denali
Denali is a biopharmaceutical company developing
a broad portfolio of therapeutic candidates for neurodegenerative
diseases. Denali pursues new treatments by rigorously assessing
genetically validated targets, engineering delivery across the
blood-brain barrier and guiding development with biomarker
monitoring to demonstrate target engagement and select patients.
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, plans to further progress
DNL758 into a Phase 1 clinical study in healthy volunteers,
Denali’s and its partner Sanofi’s plans to develop several
molecules targeting RIPK1, Denali’s beliefs and expectations
regarding the results of clinical testing, Denali’s receipt of
clinical milestone payments from Sanofi, and statements made by
Denali’s CEO.
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: the risk of the
occurrence of any event, change or other circumstance that could
give rise to the termination of the Sanofi collaboration agreement;
Denali’s early stages of clinical drug development; Denali’s and
its partners’ ability to complete the development and, if approved,
commercialization of product candidates; Denali’s dependence
on successful development of its BBB platform technology and
product candidates currently in its core program; Denali’s and its
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 and its partners’ ability to continue to create a pipeline
of product candidates or develop commercially successful products;
Denali’s and its partners’ 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 BBB platform technology; and other risks,
including those described in Denali’s Annual Report on Form 10-K
filed with the SEC on March 12, 2019, Denali’s
Quarterly Report on Form 10-Q filed with the SEC on May 8,
2019 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.
Contacts:
Lizzie Hyland(646)
495-2706lhyland@gpg.com
or
Morgan Warners(202)
295-0124mwarners@gpg.com
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