Aclaris Therapeutics Announces First Patient Dosed in Phase 2a Clinical Trial of ATI-1777, an Investigational Topical “Soft...
October 20 2020 - 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
the first patient has been dosed in Aclaris’ Phase 2a clinical
trial of ATI-1777, an investigational topical “soft” Janus kinase
(JAK) 1/3 inhibitor, for the treatment of moderate to severe atopic
dermatitis (AD). ATI-1777 was developed internally utilizing
Aclaris’ proprietary KINect™ drug discovery platform.
“We are excited about progressing this drug candidate into the
clinic,” said Dr. David Gordon, Chief Medical Officer of Aclaris.
“This trial is an important first step in the clinical development
of ATI-1777 and we hope to establish that a topical JAK inhibitor
can safely and effectively treat AD while limiting systemic
exposure.”
The Phase 2a trial is a multicenter, randomized, double-blind,
vehicle-controlled, parallel-group trial to determine the efficacy,
safety, tolerability and pharmacokinetics of ATI-1777 in subjects
with moderate or severe AD. Subjects will apply ATI-1777 or vehicle
twice daily for 28 days. Aclaris’ planned enrollment for this trial
is approximately 42 subjects and the trial will be conducted in the
U.S. The primary endpoint is the percentage change from baseline in
the Eczema Area and Severity Index (EASI) score at week 4.
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
the 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. 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, 2019, Aclaris’ Quarterly
Report on Form 10-Q for the quarter ended June 30, 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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