Aclaris Announces Phase 3 Results, Will Submit NDA In Q1 2017

Aclaris Therapeutics Inc ACRS, a small-cap clinical-stage specialty pharmaceutical company that commercializes drugs for the treatment of ermatological indications, announced after Tuesday's close results from two Phase 3 trials.

Aclaris' two pivotal Phase 3 trials have been exploring the benefits of its lead product candidate called A-101, which is a novel treatment for seborrheic keratosis.

The company said the Phase 3 trial met all of the primary and secondary endpoints of each trial and achieved clinically and statistically significant clearance of SK lesions.

The two trials enrolled 937 patients across 34 centers in the US. The trials were designed to evaluate the safety and efficacy of A-101 compared to a placebo in patients with four target SK lesions on their face, trunk and extremities.

Overall, results from the two trials showed that 51.3 percent of lesions which were treated with A-101 were assessed as clear or near clear. In addition, 65.3 percent of lesions on the face treated with A-101 were assessed as clear or near clear at trial completion versus just 10.5 percent of lesions in the placebo group.

The company noted it had already met with the U.S. Food and Drug Administration earlier this year and during a pre-New Drug Application (NDA) meeting and will submit the NDA application in the first quarter of 2017.

"I see many SK patients who lack confidence in their appearance, especially those who have lesions in visible areas such as the face and neck," said trial investigator Zoe Draelos, M.D., board-certified dermatologist, fellow of the American Academy of Dermatology. "For patients who seek to improve their appearance, a treatment that can achieve clearance or near clearance of lesions while delivering a favorable aesthetic result would represent a significant advance in the standard of SK treatment."

After opening at $24.93, shares traded recently at $23.09, down 1.4 percent.