Aclaris Therapeutics Initiates Phase 2b Clinical Trials of A-101 for Topical Treatment of Common Warts

MALVERN, Pa., June 29, 2017 -- 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
[email protected]

Media Contact
Mariann Caprino
TogoRun
917-242-1087
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