Denali Therapeutics Announces First Patient Dosed in Phase 1b Study of DNL747 for ALS
09 January 2019 - 1:00AM
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 ALS, in
collaboration with its partner Sanofi.
“Based on Phase 1 data in healthy volunteer subjects
demonstrating DNL747’s excellent CNS penetration, safety profile,
and ability to inhibit the RIPK1 pathway, we are excited to
evaluate DNL747 in ALS patients,” said Carole Ho, M.D., Chief
Medical Officer of Denali. “The primary purpose of this Phase 1b
study is to gain additional safety and biomarker data in ALS
patients to support dose selection. The results from this study
will inform decisions by Denali and our partner Sanofi on further
clinical testing of DNL747, including potential registrational
trials.”
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 ALS.
About the DNL747 Phase 1b study in
ALS
This study (NCT03757351) is a 28-day, randomized, double blind,
placebo controlled cross over design Phase 1b clinical trial in
patients with ALS. Its purpose is to evaluate safety, tolerability,
pharmacokinetics, pharmacodynamics, and target and pathway
engagement biomarkers in the CSF and blood for DNL747. Up to 26
patients in the study will be randomized to receive either DNL747
or placebo in a cross over 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 ALS; 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; 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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