Aclaris Therapeutics Submits NDA for Seborrheic Keratosis

Aclaris Therapeutics, Inc. recently announced it has submitted a New Drug Application (NDA) to the US FDA for A-101 40% topical solution (A-101) as a treatment for seborrheic keratosis (SK). A-101, an investigational drug, is being developed by Aclaris as a non-invasive, in-office topical treatment for SK.
SK lesions are common, non-cancerous skin lesions that affect more than 83 million Americans. SK lesions can have a negative physical and emotional impact on patients because they may be perceived as cosmetically unattractive and associated with aging. Existing treatments are often painful, invasive, and can have undesirable outcomes such as pigmentary changes or scarring. Fewer than 10% of people with SK lesions currently receive treatment.

Positive results from two pivotal Phase III trials – SEBK-301 and SEBK-302 – were reported in late 2016 and provide the clinical basis for this NDA submission. In these trials, A-101 met all primary and secondary endpoints, achieving clinically and statistically significant clearance of SK lesions. The two trials, which were identical in design and together enrolled 937 patients, evaluated the safety and efficacy of A-101 compared with vehicle (placebo) in patients with four target SK lesions on the face, trunk and extremities.

“This NDA submission represents a major step toward Aclaris’ goal of delivering a novel, topical treatment to address a significant unmet need in the dermatology market,” said Dr. Neal Walker, President and Chief Executive Officer of Aclaris. “If approved, we believe A-101 will have broad appeal across aesthetic and medical dermatology patients – both men and women.”

If approved, A-101 would be the first FDA-approved topical treatment for SK. Aclaris also plans to submit a marketing authorization application in the European Union in mid-2017.

A-101 40% topical solution, an investigational drug, is a proprietary, high-concentration hydrogen peroxide formulation for the treatment of seborrheic keratosis (SK). It is being developed as a non-invasive, in-office treatment administered by physicians or other licensed healthcare professionals. In clinical trials, A-101 has been observed to have statistically and clinically significant results in clearing SK lesions with an adverse event profile similar to placebo. A-101 is designed to work by penetrating into the SK lesion and causing oxidative damage, which can ultimately result in the sloughing of the SK cells. A-101 has been the focus of a robust clinical development program in which over 700 patients have been treated with A-101. A higher concentration of A-101 is also in clinical development for the treatment of common warts (verruca vulgaris).

Seborrheic keratosis (SK) is a skin condition that affects more than 83 million Americans and is characterized by non-cancerous lesions with a waxy, scaly, slightly elevated appearance that can vary in color from light tan to dark brown or black. SK lesions frequently appear in highly visible locations, such as the face or neck, and can have an adverse physical and emotional impact on people who have them. SK sufferers may be affected with just one lesion or dozens and often have a family history of SK. Prevalence of SK increases with advancing age and over three-quarters of patients seeking treatment from dermatologists are aged 40 to 69. SK is one of the most frequent diagnoses made by dermatologists, yet it remains undertreated. There are currently no FDA-approved medications for SK, and existing treatment procedures are often painful, invasive, and can have undesirable outcomes like scarring or dyspigmentation.

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. For more information, visit