Aclaris submits new drug application for skin condition med
Aclaris Therapeutics, Inc. (ACRS), a dermatologist-led, biotechnology company focused on defining new standards of care in medical and aesthetic dermatology, today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (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 3 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.