Aclaris Therapeutics Submits Investigational New Drug Application for ATI-1777, a Topical “Soft” JAK1/3 Inhibitor, for th...
July 07 2020 - 4:01PM
Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage
biopharmaceutical company developing a pipeline of novel drug
candidates for immuno-inflammatory diseases, today announced that
it has submitted an Investigational New Drug (IND) Application to
the U.S. Food and Drug Administration (FDA) for ATI-1777, an
investigational topical “soft” Janus kinase (JAK) 1/3 inhibitor,
for the treatment of moderate to severe atopic dermatitis (AD).
ATI-1777 is another compound generated from the Aclaris
KINect™ drug discovery platform, and was specifically
developed as a topical “soft” drug.
“We are very pleased to have achieved another development
milestone with the submission of this IND and look forward to
exploring the therapeutic potential of ATI-1777 in patients with
moderate to severe AD,” said Dr. David Gordon, Chief Medical
Officer of Aclaris. “ATI-1777 is designed to be active in the skin
but rapidly metabolized in the systemic circulation, with the goal
of developing a medicine that is efficacious in the treatment of AD
while limiting systemic exposure.”
If the IND is allowed, Aclaris plans to initiate a Phase 1/2a
multicenter, randomized, double-blind, vehicle-controlled trial to
investigate the safety, tolerability, pharmacokinetics, and
efficacy of topically applied ATI-1777 in subjects with moderate to
severe AD in the second half of 2020. The primary endpoint will
assess efficacy at 4 weeks.
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. If
the IND is allowed, Aclaris plans to develop 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 and follow Aclaris on LinkedIn or
Twitter @aclaristx.
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
patients with 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 March 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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