Denali Therapeutics Announces First Patient Dosed in Phase 1b Study of DNL201 for Parkinson’s Disease
December 10 2018 - 9:00AM
Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical
company developing a broad portfolio of product candidates for
neurodegenerative diseases, today announced initiation of dosing in
a Phase 1b clinical study of DNL201 in patients with Parkinson’s
disease.
“Based on the positive outcome of our Phase 1 study in 122
healthy volunteer subjects, we are excited to evaluate DNL201 in
Parkinson’s disease patients,” said Carole Ho, M.D., Chief Medical
Officer of Denali. “This study will provide additional important
safety and biomarker data in patients to support rational dose
selection. The results from this study will inform decisions on
further clinical testing of DNL201, including potential
registrational trials.”
DNL201, Denali’s lead LRRK2 therapeutic candidate, is a small
molecule inhibitor of leucine-rich repeat kinase 2 (LRRK2). LRRK2
is a regulator of lysosomal function, which is impaired in
Parkinson’s disease and may be restored by LRRK2 inhibition.
Inhibition of LRRK2 activity may potentially slow the progression
of disease in patients with a genetic LRRK2 mutation as well as in
patients with sporadic Parkinson’s disease.
Mutations in the LRRK2 gene are among the most frequent genetic
causes of Parkinson’s disease and a major driver of lysosomal
dysfunction, which contributes to the formation of Lewy body
protein aggregates and neurodegeneration.
About the DNL201 Phase 1b study
This study (NCT03710707) is a 28-day, randomized, placebo
controlled Phase 1b clinical trial in patients with mild to
moderate Parkinson’s disease, with and without genetic LRRK2
mutations. Its purpose is to evaluate safety, tolerability,
pharmacokinetics, pharmacodynamics, and target and pathway
engagement biomarkers in multiple oral doses of DNL201. Exploratory
endpoints include certain clinical endpoints. The planned 30
patients in the study will be randomized to receive either a low
dose of DNL201, a high dose of DNL201, or placebo.
Data readout from this 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 regarding, and implications and purposes of, the Phase
1b clinical study of DNL201 in patients with Parkinson’s
disease; expectations regarding patient enrollment in, and the
timing of results of, such study; plans to progress DNL201
into additional clinical studies in Parkinson’s disease
patients; Denali’s belief that inhibition of LRKK2 may have
therapeutic benefit for a broad range Parkinson’s disease
patients; 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 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 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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