Aclaris Therapeutics Completes Enrollment in Phase 2b Study of ATI-1777 for Mild to Severe Atopic Dermatitis (ATI-1777-AD-202)
03 Ottobre 2023 - 1:00PM
Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage
biopharmaceutical company focused on developing novel drug
candidates for immuno-inflammatory diseases, today announced the
completion of enrollment into ATI-1777-AD-202, its Phase 2b trial
of its investigational topical “soft” Janus kinase (JAK) 1/3
inhibitor, ATI-1777, in patients with mild to severe atopic
dermatitis. Aclaris anticipates releasing top-line efficacy, safety
and other preliminary data from this trial around the end of this
year.
“We are very pleased to have completed the enrollment stage of
our Phase 2b trial of ATI-1777 in atopic dermatitis, one of our two
lead clinical development assets,” stated Gail Cawkwell, M.D.,
Ph.D., Aclaris’ Chief Medical Officer. “With this achievement, we
are positioned for a very exciting year end for our two lead
assets, first with the data read-out of our Phase 2b trial of
zunsemetinib (ATI-450) in rheumatoid arthritis expected in
November, followed by the top-line results of the ATI-1777 trial
expected around year end.”
ATI-1777 is a topical JAK inhibitor designed to minimize
systemic exposure and delivered in a spray-on solution. The Phase
2b trial follows the successful four-week Phase 2a trial in
moderate to severe atopic dermatitis which demonstrated meaningful
improvement in the modified Eczema Area and Severity Index (EASI)
and minimal measurable systemic exposure with a 2% formulation
applied twice daily. The Phase 2b vehicle-controlled trial in
atopic dermatitis further explores the concentration range (0.5%,
1% and 2%), as well as a once-daily regimen using the 2%
formulation. The trial enrolled 250 patients with mild, moderate or
severe AD, including adults and children as young as 12-years-old,
across 34 clinical trial sites in the U.S. The primary efficacy
endpoint is the percent change in EASI over a period of 4 weeks.
Secondary measures of efficacy, as well as safety and
pharmacokinetics, will also be assessed.
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 mild to severe atopic
dermatitis. ATI-1777 is currently in clinical development, and its
safety and efficacy have not been evaluated by regulatory
authorities.
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
“anticipate,” “believe,” “expect,” “intend,” “may,” “plan,”
“potential,” “will,” and similar expressions, and are based on
Aclaris’ current beliefs and expectations. These forward-looking
statements include Aclaris’ expectations regarding the timing of
reporting results from ATI-1777-AD-202 and its Phase 2b trial of
zunsemetinib (ATI-450) in rheumatoid arthritis, and Aclaris’ plans
to develop ATI-1777 as an emollient-containing spray formulation
for the potential treatment of atopic dermatitis, and other
statements that are not historical fact. 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 macroeconomic environment 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,
2022 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 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 Therapeutics Contact:
Robert A. Doody Jr.Vice President, Investor
Relations484-639-7235rdoody@aclaristx.com
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