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Aclaris Therapeutics Announces Positive Results in Phase 2 Clinical Trial of A-101 for Treatment of Common Warts

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WART-201 Efficacy Results:
  • The primary endpoint was the mean change from baseline in the PWA score one week after the last treatment. Patients treated with 45% concentration A-101 demonstrated a statistically significant change in PWA score versus placebo (p=0.01).  
  • The secondary endpoints included two responder analyses: the proportion of patients whose target wart was judged to be clear on the PWA scale; and the proportion of patients whose target wart was judged to be either clear or barely evident on the PWA scale.
    • A-101 45% Topical solution achieved statistically significant complete clearance of the target wart one week after the last treatment versus placebo (p=0.02).
    • The proportion of target warts treated with A-101 45% Topical solution achieving a score of clear or barely evident one week after the last treatment was also statistically significant versus placebo (p=0.02).
WART-201 Safety Results:
  • A-101 was well-tolerated and local skin reactions (LSR) were primarily mild in severity and similar to placebo. The most frequently reported LSR across treatment groups was mild erythema.
“We are extremely pleased with these results,” said Dr. Neal Walker, President & CEO of Aclaris.  “This is an important milestone for our A-101 development program and substantiates the clinical value of our proprietary formulation of A-101 Topical solution. Based on these results, we plan to continue the development of the 45% concentration of A-101 as a potential treatment for common warts.”
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Occurred on:
Aug 18, 2016
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Related Keywords Phase 2 Clinical Trial, A-101, Common Warts, Pwa Scale