Aclaris Therapeutics announces in a news release it has submitted a New Drug Application (NDA) to the FDA for A-101 40% topical solution as a treatment for seborrheic keratosis (SK).
The proprietary, high-concentration hydrogen peroxide formulation is being developed as a noninvasive, in-office SK treatment administered by physicians or other licensed health care professionals. It 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.
SK is a skin condition that is characterized by non-cancerous lesions, usually on the face or neck, with a waxy, scaly, slightly elevated appearance that can vary in color from light tan to dark brown or black. Its prevalence tends to increase with advancing age, with more than three-fourths of patients seeking treatment from dermatologists being between the ages of 40 and 69.
There are currently no FDA-approved medications for SK, and existing treatments are often painful, invasive, and can lead to scarring and dyspigmentation, explains the release, from Malvern, Pa-based Aclaris Therapeutics.
Positive results from two Phase 3 trials—SEBK-301 and SEBK-302—provide the basis for the NDA application.
Together, the identically designed trials enrolled 937 patients and evaluated the safety and efficacy of A-101 compared with placebo in patients with four target SK lesions on the face, trunk, and extremities. Results suggest that A-101 achieved clinically and statistically significant clearance of the SK lesions.
“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,” says Dr Neal Walker, president and chief executive officer of Aclaris, in the release. “If approved, we believe A-101 will have broad appeal across aesthetic and medical dermatology patients—both men and women.”
If the NDA is approved, A-101 will be the first FDA-approved topical treatment available for SK, the company notes.
Aclaris also plans to submit a marketing authorization application in the European Union in mid-2017.
[Source: Aclaris Therapeutics]