Aclaris Therapeutics Initiates Phase 2b Clinical Trials of A-101 for Topical Treatment of Common Warts
June 29 2017 - 8:00AM
Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led,
biotechnology company focused on identifying, developing and
commercializing innovative and differentiated therapies to address
significant unmet needs in medical and aesthetic dermatology,
announced today the initiation of two Phase 2 clinical trials to
evaluate A-101 45% topical solution (A-101 45%), an investigational
drug for the treatment of common warts (verruca vulgaris). Over 22
million Americans have common warts, yet there are no U.S. Food and
Drug Administration (FDA) approved prescription medication for
them.
The Phase 2b studies will evaluate the safety, tolerability and
dose-frequency of A-101 45% compared with its vehicle (placebo).
Approximately 240 patients will be randomized in the two
double-blinded trials, which are being conducted at 30
investigational centers within the United States.
“We are initiating these studies subsequent to a productive
guidance meeting with the FDA,” said Dr. Neal Walker, President and
Chief Executive Officer of Aclaris. “This is an important step
forward as we advance our clinical program for A-101 45% in the
treatment of common warts.”
About Aclaris Therapeutics, Inc.Aclaris
Therapeutics, Inc. is a dermatologist-led biotechnology company
focused on identifying, developing and commercializing innovative
and differentiated therapies to address significant unmet needs in
medical and aesthetic dermatology. Aclaris is focused on
large, underserved market segments with no FDA-approved medications
or where treatment gaps exist. Aclaris is based in Malvern,
Pennsylvania and more information can be found by visiting the
Aclaris website at www.aclaristx.com.
About Common Warts Warts are benign skin
growths which appear when human papillomavirus (HPV) infects the
top layer of the skin. On an annual basis, 1.9 million people
are diagnosed with common warts and although the warts are
generally not harmful and in most cases eventually clear without
any medical treatment, they may be painful, aesthetically
unattractive, and are contagious. Common warts can be removed
with slow-acting, over-the-counter products containing salicylic
acid. Cryosurgery is the most frequently used in-office
treatment for common warts. No prescription drugs have been
approved by the FDA for the treatment of common warts.
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 and potential commercialization of A-101 for
the treatment of common warts. 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, risks associated with maintaining its intellectual
property portfolio and other risks and uncertainties that are
described in Aclaris’ Annual Report on Form 10-K for the year ended
December 31, 2016, and other filings Aclaris makes with the
SEC 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 Contact
Michael Tung, M.D.
Investor Relations
484-329-2140
mtung@aclaristx.com
Media Contact
Mariann Caprino
TogoRun
917-242-1087
M.Caprino@togorun.com
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