Aclaris Therapeutics Announces Positive Top-Line Phase 3 Results For A-101 In Treating Seborrheic Keratosis, A Common Undertreated Skin Condition

  • Pivotal Data Show Topical Treatment Delivered Statistically Significant Results, Meeting All Primary and Secondary Endpoints
  • Aclaris to Submit New Drug Application to FDA in 1Q17

Company to Host Conference Call Today at 5:00 PM ET

MALVERN, Pa., Nov. 15, 2016 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led clinical-stage pharmaceutical company focused on defining new standards of care in medical and aesthetic dermatology, today announced that two pivotal Phase 3 trials of its lead product candidate A-101 40% Topical Solution (A-101), a novel treatment for seborrheic keratosis (SK) met all primary and secondary endpoints of each trial, achieving clinically and statistically significant clearance of SK lesions.

The two trials, SEBK-301 and SEBK-302, enrolled 937 patients in total and were conducted at 34 centers in the United States.  The trials were identical in design and evaluated the safety and efficacy of A-101 compared to vehicle (placebo) in patients with four target SK lesions on the face, trunk and extremities.  Of the 937 patients enrolled, 467 patients received A-101 and 470 patients were administered placebo.  Investigators assessed the clearance of SK lesions using the validated four-point Physician Lesion Assessment (PLA) rating scale, which characterizes lesions as either clear (PLA=0), near clear (PLA=1), thin (PLA=2), or thick (PLA=3).  Patients in each trial had four target SK lesions, including at least one on the face and at least one on the trunk or extremities.  Each lesion received up to two treatments three weeks apart.  

Efficacy Results

Overall, results from the combined trials showed 51.3% of lesions treated with A-101 were assessed as clear or near clear (PLA <1) at trial completion versus 7.3% of lesions in the placebo group.  Notably, 65.3% of lesions on the face treated with A-101 were assessed as clear or near clear at trial completion versus 10.5% of lesions in the placebo group. 

The primary endpoint of both trials was the percentage of patients treated with A-101 who achieved clearance (PLA=0) of all four target SK lesions.  In the SEBK-301 trial, 4.0% of patients treated with A-101 achieved clearance of all four target SK lesions (p<0.002); in the SEBK-302 trial, 7.8% of treated patients achieved clearance of all four target SK lesions (p<0.0001).  None of the patients administered placebo achieved clearance of all four target SK lesions in either trial. 

If you liked this article you might like

Skin Lesion Drug Only Scratches the Surface, Says Aclaris CEO

New Skin Lesion Drug Only Scratches Market's Surface, Says Aclaris CEO

5 Stocks With Big Insider Buying -- Should You Love Them Too?

5 Stocks Insiders Love Right Now

Jim Cramer's 'Mad Money' Recap: Watching China Warily, Again