Aclaris Therapeutics Initiates Phase 3 Clinical Trials of A-101 for the Treatment of Seborrheic Keratosis

MALVERN, Pa., Jan. 19, 2016 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), today announced the initiation of two Phase 3 clinical trials to evaluate A-101 Topical Solution for the treatment of seborrheic keratosis (SK). 

The two Phase 3 clinical trials will evaluate the safety and efficacy of A-101 Topical Solution compared with a vehicle solution (placebo).  Approximately 800 subjects will be randomized in these multi-center, double-blinded, vehicle-controlled, clinical trials, which are being conducted at 34 investigational centers within the United States.

“The initiation of the Phase 3 program for A-101 Topical Solution is an important milestone in our development program and follows the positive Phase 2 clinical results and an End-of-Phase 2 meeting with the FDA,” said Christopher Powala, Chief Operating Officer of Aclaris. “Our goal is to offer a new treatment option for patients and physicians to treat SK lesions, a condition for which there are currently no FDA-approved drugs.”

About Seborrheic Keratosis

SK lesions are one of the most common skin tumors, affecting over 83 million people in the United States. SK lesions are often pigmented, have a waxy, scaly, slightly elevated appearance and typically multiple growths are present. While benign, these lesions are often cosmetically disturbing, may become symptomatic (irritated, pruritic [itchy], painful) or may be confused with more serious skin lesions. Currently, SK lesions are treated by cryotherapy, electrosurgery, curettage, or surgical removal. Each of these methods may be painful or can result in pigmentary changes or scarring at the treatment site.

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 seborrheic keratosis.  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
[email protected]

Investor Contact
Patricia L. Bank
Westwicke Partners
Managing Director
415-513-1284
[email protected] 

Media Contact
Mike Beyer
Sam Brown, Inc.
312-961-2502
[email protected]