Aclaris Therapeutics Announces Phase 2 Clinical Trial of ATI-502 Topical in Patients with Alopecia Areata Did Not Meet Endpoi...
June 26 2019 - 4:01PM
Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led
biopharmaceutical company focused on immuno-inflammatory diseases,
today announced results from a Phase 2 clinical trial of ATI-502
(AA-201 Topical), an investigational topical Janus Kinase (JAK) 1/3
inhibitor, in patients with alopecia areata (AA). ATI-502 did not
achieve statistical superiority at the primary or secondary
endpoints due to high rates of disease resolution in
vehicle-treated patients.
AA-201 Topical, a Phase 2 randomized, double-blinded,
parallel-group, vehicle-controlled trial, evaluated the safety,
efficacy, and dose response of two concentrations of ATI-502, 0.12%
and 0.46%, on the regrowth of hair in 129 subjects with AA.
Subjects applied ATI-502 to their scalp twice daily for 24
weeks.
The primary endpoint was the mean percent change from baseline
in the Severity of Alopecia Tool (SALT) score at week 24.
Secondary endpoints included change in Alopecia Density and Extent
(ALODEX) score and multiple investigator and patient reported
outcomes.
ATI-502 was observed to be generally well-tolerated. Adverse
events were primarily mild or moderate in severity. No
treatment-related serious adverse events were reported.
“We are surprised and extremely disappointed by the results of
this Phase 2 trial,” said Dr. Neal Walker, President and Chief
Executive Officer of Aclaris. “This is disappointing not only for
the company, but also for patients who are living with alopecia
areata. We sincerely thank the patients and investigators who
participated in this trial. We look forward to advancing our other
development programs.”
Company to Host Conference Call
Management will conduct a conference call at 5:00 PM ET today to
review the Phase 2 results and related matters. The
conference call will be webcast live over the Internet and can be
accessed by logging on to the “Investors” page of the Aclaris
Therapeutics website, www.aclaristx.com, prior to the event. A
replay of the webcast will be archived on the Aclaris Therapeutics
website for 30 days following the call.
To participate on the live call, please dial (844)
776-7782 (domestic) or (661) 378-9535 (international), and
reference conference ID 3497800 prior to the start of the
call.
About Alopecia Areata
Alopecia areata (AA) is an autoimmune disease characterized by
partial or complete loss of hair on the scalp, face or body. The
scalp is the most commonly affected area. Onset of AA may occur in
childhood and most patients experience onset by age 40. The course
of disease is unpredictable and may involve spontaneous hair
regrowth and sudden hair loss. Over half of patients with AA
experience poor health-related quality of life. The disease can be
associated with serious psychological consequences, including
anxiety and depression. AA affects up to 1.8% of people in the
United States and 2.0% of people globally at some point during
their lives.
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a physician-led biopharmaceutical
company committed to addressing the needs of people with
immuno-inflammatory diseases who lack satisfactory treatment
options. The company’s diverse and multi-stage portfolio includes
two FDA-approved medicines, one late-stage investigational
medicine, and a pipeline powered by a robust R&D engine
exploring protein kinase regulation. Aclaris Therapeutics’ active
development programs focus on areas where significant treatment
gaps exist, such as common warts, alopecia areata, and vitiligo.
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," "may," "plan," "potential," "will," and
similar expressions, and are based on Aclaris' current beliefs and
expectations. These forward-looking statements include expectations
regarding the development of Aclaris’ drug candidates. 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 and in commercialization of products, 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, 2018, 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” 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 PresidentCorporate
Strategy/Investor Relations484-329-2140mtung@aclaristx.com
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