FDA grants Fast Track Designation to Aclaris Therapeutics’ Investigational JAK Inhibitor for the treatment of Alopecia Area...
July 09 2018 - 7:00AM
Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led
biopharmaceutical company focused on identifying, developing, and
commercializing innovative and differentiated therapies to address
significant unmet needs in medical and aesthetic dermatology,
announced today that the U.S. Food and Drug Administration (FDA)
has granted Fast Track designation to Aclaris’ investigational
topical Janus Kinase (JAK) 1/3 inhibitor (ATI-502) for the
treatment of alopecia areata, including patchy alopecia areata and
the more severe variants of the disease, alopecia totalis and
universalis.
The FDA’s Fast Track designation is intended to
facilitate the development of new therapies for serious conditions
and with the potential to address an unmet medical need. A company
with an investigational medicine receiving Fast Track designation
may be eligible for more frequent communications with the FDA and
may receive an expedited review of the new drug application.
“This Fast Track designation represents a positive
step for the development of ATI-502. This designation recognizes
the unmet need that exists for patients living with this
often-devastating autoimmune disease and the impact of sudden or
unpredictable hair loss,” said Christopher Powala, Chief Regulatory
& Development Officer of Aclaris. “We look forward to working
closely with the FDA throughout our development program with the
hope of ultimately bringing this important treatment option to
patients.”
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.
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.
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 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, 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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