Shares of Aclaris(ACRS) - Get Report are up more than 22% in the three months since the drugmaker announced the success of two pivotal phase III trials for its lead product candidate, dubbed A-101, for treating skin lesions. Aclaris CEO Dr. Neal Walker said the potential market for this topical drug is over half a billion dollars.
And that's just scratching the surface.
A-101 is a proprietary topical treatment for seborrheic keratosis, or SK, a common and undertreated skin condition that affects over 83 million Americans. Aclaris is submitting its first New Drug Application for A-101 this quarter. It will also submit a marketing authorization application in the European Union in mid-2017.
"Everyone has seen SK lesions -- they're waxy, scaly, slightly elevated lesions often found on the face and neck," said Aclaris CEO Dr. Neal Walker. "A vast majority of SK patients are interested in an effective treatment provided in a dermatologist's office and willing to pay a reasonable out-of-pocket fee. However, existing treatments are often painful, invasive and may cause undesirable outcomes like pigmentary changes or scarring."
If approved, A-101 would be the first FDA-approved topical treatment for SK. Aclaris believes that A-101 will have broad appeal across aesthetic and dermatology patients -- both men and women -- with the potential to grow the market and expand physician practices with a new self-paid aesthetic treatment.
Walker said Aclaris is also pursuing additional dermatological indications for A-101, such as the treatment of common warts.
"This is another condition where there is a significant need for a simple, painless, safe and efficacious topical treatment," said Walker.
In addition, Aclaris is developing a treatment for androgenetic alopecia, or male/female pattern hair loss.
"It's a logical extension of our portfolio, since we are targeting white space indicators of those that have no FDA-approved drugs," said Walker.