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Blog Exposure - Aclaris Therapeutics Shares Positive Update on Phase-2 Results after a 3-Month Follow-Up of A-101 45% Topical Solution

Stock Monitor: Aurinia Pharma Post Earnings Reporting

LONDON, UK / ACCESSWIRE / March 21, 2018 / Active-Investors.com has just released a free research report on Aclaris Therapeutics, Inc. (NASDAQ: ACRS). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=ACRS as the Company's latest news hit the wire. On March 19, 2018, the Company, which is a dermatologist-led biopharmaceutical organization committed towards identifying, developing, and commercializing innovative therapies for addressing unmet needs in dermatology and immunology, shared positive results from a 3-month, post-treatment, follow-up evaluation period of its twice-weekly placebo-controlled WART-203 Trial of A-101 45% topical solution (A-101 45%). Register today and get access to over 1000 Free Research Reports by joining our site below:

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Active-Investors.com is currently working on the research report for Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH), which also belongs to the Healthcare sector as the Company Aclaris Therapeutics. Do not miss out and become a member today for free to access this upcoming report at:

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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Aclaris Therapeutics most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:

www.active-investors.com/registration-sg/?symbol=ACRS

Common Warts, An Unmet Medical Need

Common warts is a condition wherein skin cells are infected by human papillomavirus (HPV) and spreads via direct contact or contact with infected surfaces. Common warts, which look like skin-colored papules with a rough surface, mostly occur on hands. At present, common warts, or verruca vulgaris, affects about 22 million Americans. The condition is more prevalent in children than adults. Over 2 million people take treatment for common warts from healthcare professionals every year, mainly due to symptoms such as pain, bleeding, itching, and burning.

As of now, there are no US Food and Drug Administration (FDA)-approved prescription medications for warts. The currently available over-the-counter topical treatments for common warts are slow and hardly effective. These treatments are known to have undesirable outcomes such as scarring or depigmentation, and mostly require repeated visits.

A-101 for Treatment of Warts

A-101 45% topical solution (A-101 45%) is an investigational new drug that is being developed as a prescription treatment for common warts. It comprises proprietary high-concentration hydrogen peroxide topical solution.

WART-203 Study Design

The WART-203 Trial evaluated the safety and efficacy of A-101 45% in comparison to placebo in a randomized, double-blind, vehicle-controlled trial, with a 3-month post-treatment follow-up period. The rationale behind the 3-month follow-up period was to analyze the clinical effect of the twice-weekly treatment regimen for 8 weeks, as well as the durability of the clinical effect.

Earlier, A-101 45% met the trial endpoints related to the reduction and clearance of common warts versus placebo in the 56-day treatment period. Post that, subjects continued with the 3-month follow-up portion of the trial.

The WART-203 trial assessed 159 subjects who self-administered either A-101 45% or placebo twice-weekly for 56 days, for a total of 16 treatments. Of these 159 subjects, 151 subjects were able to complete the 3-month post-treatment follow-up period in compliance with the protocol. It must be noted that each subject reported between one and six warts at baseline. In this trial, the primary efficacy analysis was based on the mean change from baseline in the Physician's Wart Assessment (PWA) scale score at Day 56 (Visit 8) and Day 134 (Visit 13). The PWA score is a four-point scale of the investigators' static assessment of the severity of a target wart at a particular time point.

Significant improvements were noted in common wart reduction and clearance versus placebo among subjects treated with A-101 45% in the 3-month post-treatment follow-up period, i.e. at Day 134.

Study Results

The primary efficacy analysis of the WART-203 trial

  • At Day 56, the mean reduction in PWA score on the target warts was 0.87 points in subjects who received A-101 45% compared to a mean reduction of 0.17 points for the subjects treated with placebo (p<0.001).
  • At Day 134, the mean reduction in PWA score on the target warts was 1.0 point in subjects who received A-101 45%, in comparison to a reduction of 0.39 points for subjects that received placebo, which is a statistically significant result (p = 0.0004).

Secondary and exploratory endpoints of the WART-203 trial

  • At Day 56, subjects who received A-101 45% had 30.2% treated warts that were clear (PWA= 0) compared to 9.2% among subjects in the placebo group (p<0.0001). At Day 134, subjects who received A-101 45% had 39.2% treated warts that were clear compared to 17.2% among subjects in the placebo group (p<0.0001).
  • At Day 56, 25.3% of the subjects who received A-101 45% achieved target wart compared to 2.6% among subjects in the placebo group (p<0.0001). At Day 134, the 37.3% of subjects who received A-101 45% achieved target wart clearance compared to 11.8% among subjects in the placebo group (p<0.0002).
  • At Day 56, the proportion of subjects with all treated wart(s) clear (PWA= 0), stratified by the baseline number of warts treated (1-6), was 19.0% for those who received A-101 45%. This was substantially higher than 2.6% for subjects in the placebo group (P=0.001). At Day 134, the proportion of subjects with all treated wart(s) clear, stratified by the baseline number of warts treated (1-6), was 33.3% for those who received A-101 45% compared to 7.9% for subjects in the placebo group (P=0.0002).

Safety Results

No treatment-related serious adverse events were observed among subjects treated with A-101 45%.

Stock Performance Snapshot

March 20, 2018 - At Tuesday's closing bell, Aclaris Therapeutics' stock was slightly up 0.45%, ending the trading session at $17.96.

Volume traded for the day: 237.62 thousand shares.

After yesterday's close, Aclaris Therapeutics' market cap was at $558.56 million.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 0.1% at the end of the session.

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