NOVEMBER 6, 2013
Aclaris Therapeutics Initiates IND-Directed Program for A-101 for the Treatment of Seborrheic Keratosis, Common Type of Skin Tumor
Malvern, PA, November 6, 2013 – Aclaris Therapeutics Inc., a privately-held specialty pharmaceutical company dedicated to developing dermatological therapeutics, announced today the initiation of the first clinical trial of the company's lead product A-101, a topically-applied therapy. A-101 is being investigated in adult patients for the removal of seborrheic keratosis, one of the most common types of benign skin tumors.
The initial study is designed to evaluate three concentrations of A-101 compared with its vehicle (placebo) in a double-blinded, placebo-controlled, clinical trial of 36 patients with seborrheic keratosis. Results from the study are expected in the first half of 2014.
"This important study will evaluate the tolerability and safety as well as initial efficacy of A-101 in removing seborrheic keratosis lesions," said Christopher Powala, chief operating officer of Aclaris. "There are currently no FDA-approved treatments for this condition and A-101 has the potential to address this unmet medical need."
Seborrheic keratosis is the most common benign tumor seen in older individuals, affecting approximately 83 million people in the U.S. Currently, seborrheic keratosis lesions are treated using invasive methods such as cryosurgery, electrosurgery, curettage, or surgical removal which often result in pigmentary changes and/or scarring at the treatment site. According to Guy Webster, M.D., PhD, clinical professor of dermatology at Thomas Jefferson University, "Seborrheic keratoses are disfiguring and often uncomfortable. An effective, FDA-approved therapy with the ability to minimize the risk of scarring or pigmentary changes would be a real step forward for patients and physicians."
About Seborrheic Keratosis
Seborrheic keratosis is one of the most common types of skin tumors in man. These benign (non-cancerous) skin tumors affect a majority of middle-aged to older adults and impact men and women equally. Seborrheic keratosis typically presents as slowly growing lesions that may vary in color from flesh-colored to yellow, tan, brown, or black. Seborrheic keratoses sometimes resemble warts, moles, or skin cancers. While the growths may be solitary, they often occur in large numbers which can be cosmetically disturbing and in some cases disfiguring, leading to social stigma and diminished self-esteem. Though biologically benign, these lesions may become symptomatic (irritated, itchy or painful) and require removal for medical indications. Seborrheic keratosis most commonly occurs on the trunk, but may appear virtually anywhere on the skin.
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc., started by the founders of Vicept Therapeutics, is a privately held specialty pharmaceutical dermatology company focused on the development of novel dermatologic therapies. The company's mission is to develop the first effective topically applied therapy directed toward the removal of seborrheic keratosis and other verrucoid disorders of the skin. The company is also pursuing the development of topical agents for the treatment and prevention of a number of medical and cosmetic indications. Visit www.aclaristx.com for more information.
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