Denali Therapeutics Announces First Patient Dosed in Phase 1b Study of DNL747 for Alzheimer’s Disease
February 15 2019 - 9:00AM
Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical
company developing a broad portfolio of therapeutic candidates for
neurodegenerative diseases, today announced initiation of dosing in
a Phase 1b clinical study of DNL747 in patients with Alzheimer’s
disease, in collaboration with its partner Sanofi.
“We are excited to advance DNL747 in a second neurodegeneration
indication based on Phase 1 healthy volunteer data regarding
DNL747’s safety profile, CNS penetration, and target engagement, at
the studied doses.” said Carole Ho, M.D., Chief Medical Officer of
Denali. “Similar to our previously announced Phase 1b study in ALS,
the primary purpose of this Phase 1b study is to gain additional
safety and biomarker data in patients with Alzheimer’s disease to
support dose selection. The results from this study will inform our
decisions on future clinical studies in Alzheimer’s 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. Denali, together with its partner Sanofi, is investigating
several molecules targeting RIPK1 for multiple indications,
including DNL747 for Alzheimer’s disease, ALS, and Multiple
Sclerosis. In January 2019, Denali announced the initiation of
dosing in a Phase 1b clinical study of DNL747 in patients with
ALS.
About the DNL747 Phase 1b study in Alzheimer’s
disease
This study (NCT03757325) is a 28-day, randomized, double-blind,
placebo-controlled crossover design Phase 1b clinical trial in
patients with Alzheimer’s disease. Its purpose is to evaluate
safety, tolerability, pharmacokinetics, pharmacodynamics, and
target and pathway engagement biomarkers in the CSF and blood for
oral doses of DNL747. Up to 26 patients in the study will be
randomized to receive either DNL747 or placebo in a crossover
design study.
Data readout from this Phase 1b study is expected during Q4
2019. Further details are available at ClinicalTrials.gov.
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 and
expectations by Denali and its partner Sanofi regarding, and
implications and purposes of, the Phase 1b clinical study of DNL747
in patients with Alzheimer’s disease; expectations regarding what
the results will inform; expectations regarding patient enrollment
in, and the timing of results of, such study; expectations for
future clinical development activities; Denali’s belief that
inhibition of RIPK1 may have therapeutic benefit in several disease
indications; and statements made by Denali’s CMO. 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: Denali’s early stages of clinical drug
development; Denali’s ability to complete the development and, if
approved, commercialization of its product candidates; Denali’s
dependence on successful development of its BBB platform technology
and product candidates currently in its core program; Denali’s
ability to enroll patients in, conduct, or complete, clinical
trials on expected timelines; the uncertainty that any of Denali’s
product candidates will receive regulatory approval necessary to be
commercialized; Denali’s partnership with Sanofi and Sanofi’s
intentions regarding future development of DNL747; the risk of the
occurrence of any event, change or other circumstance that could
give rise to the termination of the partnership with Sanofi;
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 BBB platform technology; and other risks, including those
described in Denali’s Annual Report on Form 10-K filed with the
SEC on March 19, 2018, Denali’s Quarterly Report on Form
10-Q filed with the SEC on November 8, 2018 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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