Denali Therapeutics Announces Phase 1b Study by Partner Sanofi of RIPK1-Inhibitor DNL758 (SAR443122) in COVID-19 Patients
July 29 2020 - 9:00AM
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 that its partner Sanofi
has commenced dosing of DNL758, a peripherally-restricted small
molecule inhibitor of RIPK1, in a Phase 1b study in hospitalized
adult patients with severe COVID-19 lung disease.
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. The scientific rationale in treating severe COVID-19 with a
RIPK1 inhibitor compound is to attenuate the exaggerated immune
response to the SARS-CoV-2 viral infection and thereby limit
potential tissue damage resulting from excessive inflammation and
aim to improve patient recovery.
“We know that inhibition of RIPK1, a known target in the
TNF-pathway, can significantly modulate the body’s immune
response," said Ryan Watts, Ph.D., CEO. “Our partner Sanofi is
expanding its clinical investigation of DNL758 into patients with
severe COVID-19. We are proud to stand with Sanofi in this effort,
with the aim to contribute solutions in the fight against this
terrible pandemic.”
Denali and Sanofi entered a broad partnership in October 2018
for the global development and commercialization of RIPK1
inhibitors. Beyond COVID-19, the partners are currently
investigating DNL788 for CNS indications and DNL758 for peripheral
inflammatory indications. Sanofi is responsible for the development
and commercialization of DNL758, and covers all costs related to
DNL758, and Denali is entitled to receive development and sales
milestone payments and royalties on product sales.
Further information on the Phase 1b clinical study with
DNL758/SAR443122 for COVID-19 (study number NCT04469621) can be
accessed on the ClinicalTrials.gov website or by clicking here.
About Denali
Denali Therapeutics is a biopharmaceutical company developing a
broad portfolio of product candidates engineered to cross the
blood-brain barrier for neurodegenerative diseases. Denali
Therapeutics 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 Therapeutics is based in South San
Francisco. For additional information, please visit
http://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, timelines and
expectations related to DNL758 by both Denali and Sanofi;
expectations regarding the dosing of DNL758 in a Phase 1b study in
hospitalized adult patients with severe COVID-19 lung disease and
potential results; and statements made by Denali’s Chief Executive
Officer.
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: any and all risks to Denali’s business and
operations caused directly or indirectly by the evolving COVID-19
pandemic; 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
and its partners’ ability to enroll patients in its ongoing and
future clinical trials; Denali’s reliance on third parties for the
manufacture and supply of its product candidates for clinical
trials; 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 dependence on successful
development of its BBB platform technology; 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 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 and
uncertainties, including those described in Denali’s most recent
Annual Report on Form 10-K, most recent Quarterly Report on From
10-Q 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.
Denali ContactMorgan Warners(202)
295-0124mwarners@gpg.com
Sanofi ContactAshleigh Koss(908)
981-8745Ashleigh.Koss@sanofi.com
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