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Aclaris Therapeutics Initiates Phase 2 Clinical Trial of A-101 for Treatment of Common Warts

MALVERN, Pa., Dec. 7, 2015 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS) today announced that it has initiated a Phase 2 clinical trial to evaluate its investigational drug, A-101 Topical Solution, for the treatment of common warts (verruca vulgaris).

This double-blinded, randomized Phase 2 trial, to be conducted at five sites in the United States, will evaluate the safety, tolerability and dose-response of two concentrations of A-101 compared with a vehicle control. Aclaris intends to enroll approximately 108 subjects in this clinical trial.

"This trial is the first step in evaluating the potential clinical benefit of A-101 in the treatment of common warts," said Dr. Neal Walker, President and CEO of Aclaris. "Studying A-101 in a second dermatological condition, in addition to our ongoing work in seborrheic keratosis, is an important milestone as we continue to expand our development pipeline."

About Common Warts

Common warts are benign (non-cancerous), virally induced skin lesions caused by subtypes of the human papillomavirus (HPV) family. Warts are contagious and infection occurs most commonly through direct contact with individuals who harbor the virus, contact with contaminated surfaces, or by spread of the virus from individual lesions to adjacent skin. Common warts appear as thickened or "rough-feeling" papules that are most often located on the fingers, hands, knees and elbows, though they may occur at other anatomical locations. Approximately 1.9 million people are diagnosed with common warts annually in the United States. Currently, there are no prescription drugs approved by the FDA for the treatment of common warts.

About Aclaris

Aclaris Therapeutics, Inc. is a clinical-stage specialty pharmaceutical company focused on identifying, developing and commercializing innovative and differentiated drugs to address significant unmet needs in dermatology. Aclaris Therapeutics, Inc. is based in Malvern, Pennsylvania and more information can be found by visiting the company's website at www.aclaristx.com.

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 clinical development of Aclaris' A-101 drug candidate 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, and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Quarterly Report on Form 10-Q for the quarter ended September 30, 2015, filed with the Securities and Exchange Commission (SEC) on November 18, 2015, 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.

CONTACT: Aclaris Contact Dr. Neal Walker President & CEO 484-324-7933 investors@aclaristx.com Investor Contact Patricia L. Bank Westwicke Partners Managing Director 415-513-1284 patti.bank@westwicke.com Media Contact Mike Beyer Sam Brown, Inc. 312-961-2502 mikebeyer@sambrown.com

Source:Aclaris Therapeutics, Inc.

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