The NDA acceptance by the
“The FDA’s acceptance of our NDA for A-101 40% is a significant achievement that brings Aclaris one step closer to providing an innovative treatment option for SK patients and the physicians who treat the condition,” said
About A-101
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 health care professionals. In clinical trials, patients treated with A-101 40% achieved statistically and clinically significant improvement in clearing SK lesions compared to placebo and with a similar adverse event profile. A-101 40% 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 40% has been the focus of a robust clinical development program in which over 700 patients have been treated with A-101. The 45% concentration of A-101 is also in clinical development for the treatment of common warts (verruca vulgaris).
About Seborrheic Keratosis
Seborrheic keratosis (SK) is a skin condition that affects more than 83 million Americans and is characterized by non-cancerous lesions varying in color from light tan to dark brown or black. SK lesions range in size from a millimeter to a few centimeters wide and usually have a slightly elevated, waxy, scaly appearance. People with SK may be affected with just one lesion or dozens and often have a family history of SK. SK lesions can appear anywhere on the body, except the palms, soles, and mucous membranes, and frequently appear in highly visible locations, such as the face or neck. Though the lesions usually do not cause physical discomfort, SK can adversely affect the appearance and emotional well-being of people who have it. Prevalence of SK increases with advancing age and the majority of patients seeking treatment from dermatologists are between 40 and 70 years of age. Fewer than 10% of people with SK receive treatment, though it is one of the most frequent diagnoses made by dermatologists. There are currently no
About
Cautionary Note Regarding Forward-Looking Statements (SK only press releases)
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan,” “potential,” “will,” and similar expressions, and are based on Aclaris’ current beliefs and expectations. These forward-looking statements include expectations regarding Aclaris’ clinical development of A-101 for the treatment of SK. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris’ reliance on third parties over which it may not always have full control, risks associated with maintaining its intellectual property portfolio and other risks and uncertainties that are described in Aclaris’ Annual Report on Form 10-K for the year ended
Aclaris ContactMichael Tung , M.D. Investor Relations 484-329-2140 mtung@aclaristx.com Media ContactMariann Caprino TogoRun 917-242-1087 M.Caprino@togorun.com