MALVERN,P, USA I June 30, 2014 I Aclaris Therapeutics, Inc. today announced positive results from a Phase 2 clinical trial of the Company’s lead drug, A-101. In the trial, A-101 demonstrated clinically and statistically significant improvements in clearing seborrheic keratoses (SK), one of the most common types of skin tumors. While benign, many patients elect to have SK treated either because the lesions have become irritated or are cosmetically concerning.
The double-blind, placebo-controlled Phase 2 clinical trial was designed to evaluate the safety, tolerability, and efficacy of A-101 in removing SK lesions. The trial used a within-subject design to compare three concentrations of A-101 and vehicle (placebo) in 35 patients with SK lesions. A-101 achieved statistical significance in clearing SK lesions on the back in a dose-related fashion. A-101 was well tolerated at all concentrations.
“These results are an important step forward in validating the potential of A-101 to successfully remove SK lesions non-invasively and without the unwanted side-effects of current treatments such as scarring or skin pigment changes,” said Dr. Neal Walker, president and CEO of Aclaris. “We recently initiated a Phase 2b study as we continue to advance the clinical development program for A-101.”
SK is one of the most common benign tumors seen in older adults, affecting approximately 83 million people in the U.S.1 SK lesions have a waxy, scaly, slightly elevated appearance and often multiple growths are present. Currently, SK lesions are treated using modalities such as cryosurgery, electrosurgery, curettage, or surgical removal, which often result in pigmentary changes and/or scarring at the treatment site.
“The most common complaint from patients with seborrheic keratosis is the appearance of the lesions, which can lead to social stigma,” said James Leyden, M.D., professor emeritus at the University of Pennsylvania. “There are currently no FDA-approved treatments to address SK. If approved, A-101 could offer patients and physicians an important new option to treat this unmet medical need.”
About Seborrheic Keratosis
Seborrheic keratoses are one of the most common skin tumors, affecting a majority of middle-aged to older adults. While benign, these lesions are often cosmetically disturbing, may become symptomatic (irritated, pruritic (itchy), painful) or may be confused with more serious skin lesions. Numerous surgical/destructive treatment options for SK exist; however, they are typically painful and are often complicated by significant adverse cosmetic outcomes including pigmentary changes and/or scarring. There are currently no therapies approved by the U.S. Food and Drug Administration (FDA) for the treatment of seborrheic keratosis.
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a privately-held specialty pharmaceutical company with a mission to develop the first topically applied therapy directed toward the removal of seborrheic keratosis (SK) and other verrucoid lesions of the skin. The Company is based in Malvern, Pennsylvania and more information can be found by visiting the Company’s website at www.aclaristx.com.
1 Reference: Lewin Group, Burden of Skin Diseases Report, 2004.
SOURCE: Aclaris Therapeutics
