Aclaris Therapeutics Announces First Patient Dosed in a Phase 2 Clinical Trial of ATI-501 Oral Suspension in Patients with Al...
June 26 2018 - 7:00AM
Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led
biopharmaceutical company committed to identifying, developing, and
commercializing innovative therapies to address significant unmet
needs in aesthetic and medical dermatology and immunology, today
announced that the first patient has been dosed in Aclaris’ Phase 2
clinical trial of its JAK inhibitor product candidate ATI-501 oral
suspension in patients with two forms of Alopecia Areata (AA) known
as Alopecia Totalis (AT) and Alopecia Universalis (AU). AA is
an autoimmune dermatologic condition typically characterized by
patchy non-scarring hair loss on the scalp and body. More severe
forms of AA include AT, which is total scalp hair loss, and AU,
which is total hair loss on the scalp and body.
This multicenter, randomized study, known as AUAT-201, will
evaluate the safety, tolerability and efficacy of ATI-501 oral
suspension for the treatment of AU or AT in adult subjects.
Aclaris intends to enroll approximately 80 subjects with a clinical
diagnosis of stable AU or AT. Enrolled subjects will receive
either ATI-501 or placebo for 6 months.
The primary efficacy endpoint is the mean change from baseline
in the Severity of Alopecia Tool (SALT) score at Week 24. Secondary
and exploratory endpoints include the change from baseline in the
Alopecia Density and Extent Score (ALODEX) score and various
clinician and patient-reported outcomes.
“This trial is the first step in evaluating the potential
clinical benefit of ATI-501 oral suspension in treating patients
with the alopecia totalis and alopecia universalis forms of
alopecia areata,” said Dr. Stuart Shanler, Chief Scientific Officer
of Aclaris. “This is an important step forward in understanding the
clinical utility of our JAK inhibitors in patients with AA.”
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a dermatologist-led
biopharmaceutical company committed to identifying, developing, and
commercializing innovative therapies to address significant unmet
needs in dermatology, both aesthetic and medical, and immunology.
Aclaris’ focus on market segments with no FDA-approved medications
or where treatment gaps exist has resulted in the first
FDA-approved treatment for raised seborrheic keratoses and several
clinical programs to develop medications for the potential
treatment of common warts, alopecia areata, and vitiligo. For
additional information, please visit www.aclaristx.com and follow
Aclaris on LinkedIn.
About Alopecia Areata
Alopecia areata is an autoimmune disease that results in partial
or complete loss of hair on the scalp and body. The scalp is the
most commonly affected area, but any hair-bearing site can be
affected alone or together with the scalp. Onset of the disease can
occur throughout life and affects both women and men. AA can be
associated with serious psychological consequences, including
anxiety and depression. AA affects up to 2.0% of people globally at
some point during their lifetime (i.e. incidence) and up to 0.2% of
people are affected at any given time (i.e. prevalence). There are
currently no drugs approved by the FDA for the treatment of AA.
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", "may", "plan," "potential," "will," and
similar expressions, and are based on Aclaris' current beliefs and
expectations. These forward-looking statements include expectations
regarding Aclaris’ clinical development of its JAK inhibitor drug
candidate ATI-501 oral suspension. 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, 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, 2017, Aclaris’ Quarterly
Report on Form 10-Q for the quarter ended March 31, 2018, and other
filings Aclaris makes with the U.S. Securities and Exchange
Commission from time to time. These documents are available under
the "Financial Information" section of the Investors page 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 ContactMichael Tung, M.D.Senior Vice President Corporate
Strategy/Investor Relations484-329-2140mtung@aclaristx.com
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