Aclaris Therapeutics Completes Enrollment in its Phase 2a Clinical Trial of ATI-1777 for Moderate to Severe Atopic Dermatitis...
March 15 2021 - 7:00AM
Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage
biopharmaceutical company focused on developing novel drug
candidates for immuno-inflammatory diseases, today announced that
it has completed enrollment in its Phase 2a clinical trial of
ATI-1777, an investigational topical “soft” Janus kinase (JAK) 1/3
inhibitor, for the potential treatment of moderate to severe atopic
dermatitis (AD) (ATI-1777-AD-201).
ATI-1777-AD-201 is a Phase 2a, multicenter, randomized,
double-blind, vehicle-controlled, parallel-group clinical trial to
determine the efficacy, safety, tolerability and pharmacokinetics
of ATI-1777 in subjects with moderate to severe AD. Subjects will
apply ATI-1777 or vehicle twice daily for 4 weeks. The primary
endpoint is the percentage change from baseline in the Eczema Area
and Severity Index (EASI) score at week 4.
“This is an important trial because it explores whether a
topical JAK inhibitor can successfully treat moderate to severe AD
rather than mild disease,” said Dr. David Gordon, Chief Medical
Officer of Aclaris. “We hope to establish that a topical JAK
inhibitor can safely and effectively treat moderate to severe AD
while limiting systemic exposure.”
Dr. Neal Walker, President and CEO of Aclaris, said, “This is
another important milestone for the Company for its second
development program generated by KINect®, our proprietary drug
discovery platform. Earlier this year, we announced our positive
preliminary topline results for our Phase 2a clinical trial of
ATI-450, our investigational oral MK2 inhibitor, for moderate to
severe rheumatoid arthritis. We are very pleased with the progress
of our development programs.”
Aclaris expects data from this trial by mid-year 2021.
About ATI-1777
ATI-1777 is an investigational topical “soft” Janus kinase (JAK)
1/3 inhibitor. “Soft” JAK inhibitors are designed to provide JAK
inhibition at the site of application and be rapidly metabolized in
systemic circulation. Aclaris plans to develop ATI-1777 as an
emollient-containing spray formulation. Aclaris is developing
ATI-1777 as a potential treatment for moderate to severe atopic
dermatitis.
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical
company developing a pipeline of novel drug candidates to address
the needs of patients with immuno-inflammatory diseases who lack
satisfactory treatment options. The company has a multi-stage
portfolio of drug candidates powered by a robust R&D engine
exploring protein kinase regulation. For additional information,
please visit www.aclaristx.com.
Cautionary Note Regarding Forward-Looking
Statements
Any statements contained in this press release that do not
describe historical facts may constitute forward-looking statements
as that term is defined in the Private Securities Litigation Reform
Act of 1995. These statements may be identified by words such as
“believe,” “expect,” “intend,” “may,” “plan,” “potential,” “will,”
and similar expressions, and are based on Aclaris’ current beliefs
and expectations. These forward-looking statements include
expectations regarding ATI-1777 as a potential treatment for
moderate to severe atopic dermatitis and the clinical development
of ATI-1777, including the timing of data for ATI-1777-AD-201.
These statements involve risks and uncertainties that could cause
actual results to differ materially from those reflected in such
statements. Risks and uncertainties that may cause actual results
to differ materially include uncertainties inherent in the conduct
of clinical trials, Aclaris’ reliance on third parties over which
it may not always have full control, Aclaris’ ability to enter into
strategic partnerships on commercially reasonable terms, the
uncertainty regarding the COVID-19 pandemic and other risks and
uncertainties that are described in the Risk Factors section of
Aclaris’ Annual Report on Form 10-K for the year ended December 31,
2020 and other filings Aclaris makes with the U.S. Securities and
Exchange Commission from time to time. These documents are
available under the “SEC Filings” page of the “Investors” section
of Aclaris’ website at http://www.aclaristx.com. Any
forward-looking statements speak only as of the date of this press
release and are based on information available to Aclaris as of the
date of this release, and Aclaris assumes no obligation to, and
does not intend to, update any forward-looking statements, whether
as a result of new information, future events or otherwise.
Aclaris Contact
investors@aclaristx.com
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