Denali Therapeutics Announces First Patient Dosed in Phase 1b Study of DNL151 for Parkinson’s Disease and Launch of Its Eng...
04 September 2019 - 11:00PM
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 LRRK2 inhibitor DNL151 in patients
with Parkinson’s disease, and the launch of its Engage Parkinson’s
website.
“Based on data generated from our prior study in healthy
volunteer subjects, we are excited to evaluate DNL151 in
Parkinson’s disease patients,” said Carole Ho, M.D., CMO. “We
believe that this study will provide additional important safety
and biomarker data in patients to inform the choice between either
DNL151 or DNL201 for potential registrational trials.”
DNL151 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 all patients with Parkinson’s disease
based on restoration of lysosomal function.
“We are encouraged by the progress with our LRRK2 clinical
program,” said Ryan Watts, Ph.D., CEO. “The launch of our Engage
Parkinson’s website is intended to strengthen our engagement and
interactions with the Parkinson’s disease patient community. This
is an important part of our efforts to connect with patients who
may be eligible for our current and future clinical trials.”
About the DNL151 Phase 1b study
This study (NCT04056689) is a 28-day, multicenter, randomized,
placebo controlled, double-blind 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, target and
pathway engagement biomarkers as well as certain exploratory
clinical endpoints, in multiple oral doses of DNL151. Patients in
the study will be randomized to receive either a low dose of
DNL151, a high dose of DNL151, or a placebo. It is expected that
total enrollment for the study will be 24 patients.
Data readout from this study is expected to be presented in
early 2020. Further details are available at
ClinicalTrials.gov.
About the EngageParkinsons.com Website
EngageParkinsons.com – The Denali Parkinson’s disease patient
engagement website provides patients, caregivers, healthcare
professionals, and advocates an online destination for emerging
information about Parkinson’s disease. In addition, Engage
Parkinson’s describes Denali’s biomarker-driven approach in
discovering and developing investigational therapies for
Parkinson’s patients.
Engage Parkinson’s provides an avenue for registrants to engage
with Denali’s team to learn more about Denali sponsored clinical
trials, including clinical studies in DNL151 and DNL201 in
Parkinson’s patients with and without the LRRK2 mutation.
Registrants will also receive communications from Denali on
progress in emerging Parkinson’s research and development insights,
including information regarding future Denali investigational
studies.
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 through biomarkers that 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 to
progress DNL151 or DNL201 into a registrational clinical study in
Parkinson’s disease patients in 2020; expectations regarding what
the results will inform, expectations regarding patient enrollment
in, and the timing of results of, such study; Denali’s plans to
conduct further clinical testing in this area; and statements made
by Denali’s CMO and 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: 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 ability to 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, 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 August 6, 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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