Aclaris Therapeutics Announces Positive Update on Phase 2 Results after a 3-month Follow-Up of A-101 45% Topical Solution for...
March 19 2018 - 8:00AM
Aclaris Therapeutics, Inc. (NASDAQ:ACRS) today announced
positive results from the 3-month, post-treatment, follow-up
evaluation period of its twice-weekly placebo-controlled trial
(WART-203) of A-101 45% topical solution (A-101 45%), an
investigational new drug consisting of a proprietary
high-concentration hydrogen peroxide topical solution being
developed as a prescription treatment for common warts (verruca
vulgaris). As previously reported, A-101 45% met the trial
endpoints related to reduction and clearance of common warts versus
placebo during the initial 56-day treatment period. Over the
3-month post-treatment follow-up period, greater improvements in
common wart reduction and clearance vs. placebo were observed among
subjects treated with A-101 45%.
WART-203 evaluated the safety and efficacy of A-101 45% as
compared to placebo (vehicle) in a randomized, double-blind,
vehicle-controlled trial with a 3-month post-treatment follow-up
period. This 3-month follow-up period was designed to understand
the clinical effect of the twice weekly treatment regimen for 8
weeks and durability of the clinical effect.
Statistically significant results related to common wart
reduction and clearance were previously reported after the 56-day
treatment period. Subjects then continued into the 3-month
follow-up portion of the trial. The WART-203 trial evaluated 159
subjects who self-administered either A-101 45% or placebo twice
weekly through Day 56, for a total of 16 treatments. Of the 159
subjects randomized, 151 subjects completed the 3-month
post-treatment follow-up period in compliance with the protocol.
Each subject had between one and six warts at baseline. The primary
efficacy analysis was assessed 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. At the end of
the 3-month follow-up period, at Day 134, subjects in the A-101 45%
group showed greater improvement vs. placebo.
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 points in subjects who received A-101 45%,
compared to a reduction of 0.39 points for subjects that received
placebo, a result that was statistically significant (p =
0.0004).
Secondary and exploratory endpoints of the WART-203 trial:
- At Day 56, the percentage of all treated warts that were clear
(PWA= 0) was 30.2% in subjects who received A-101 45%, compared to
9.2% among subjects in the placebo group (p<0.0001). At
Day 134, the percentage of all treated warts that were clear was
39.2% in subjects who received A-101 45%, compared to 17.2% among
subjects in the placebo group (p<0.0001).
- At Day 56, the proportion of subjects achieving target wart
clearance (PWA= 0) was 25.3% among those who received A-101 45%,
compared to 2.6% among subjects in the placebo group
(p<0.0001). At Day 134, the proportion of subjects
achieving target wart clearance was 37.3% among those who received
A-101 45%, 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% among those who received A-101 45%, compared to
2.6% among 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%
among those who received A-101 45%, compared to 7.9% among subjects
in the placebo group (P=0.0002).
Safety Results
- There were no treatment-related serious adverse events among
subjects treated with A-101 45%.
- A-101 45% was generally well tolerated through visit 13 (Day
134).
“We are extremely pleased by these results,” said Stu Shanler,
M.D., Chief Scientific Officer. “This is an important milestone for
the A-101 45% wart program, and these data further substantiate the
potential clinical utility of our proprietary formulation of A-101
45% topical solution. Based on these results, we plan to meet
with the FDA mid-year regarding our Phase 3 program for the
treatment of common warts. We expect to initiate our Phase 3
program in the second half of 2018.”
About Common Warts Common warts, also called
verruca vulgaris, affect more than 22 million Americans. Prevalence
is higher in children than adults. Common warts most often appear
on the hands and usually look like skin-colored papules with a
rough surface. They result when skin cells are infected by human
papillomavirus (HPV) and spread via direct contact or contact with
infected surfaces. Though common warts may resolve without
treatment, they can persist for years. Over-the-counter topical
treatments are first-line therapy for common warts but are
marginally effective and slow to work. More than two million
patients seek treatment for common warts from healthcare
professionals each year, possibly because of social stigma,
embarrassment or symptoms such as pain, bleeding, itching and
burning. There are currently no FDA-approved prescription
medications for warts, and existing treatment procedures are often
painful or invasive, can have undesirable outcomes like scarring or
dyspigmentation, and often require repeat visits.
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a dermatologist-led
biopharmaceutical company committed to identifying, developing, and
commercializing innovative therapies to address significant unmet
needs in dermatology, both aesthetic and medical, and immunology.
Aclaris’ focus on market segments with no FDA-approved medications
or where treatment gaps exist has resulted in the first
FDA-approved treatment for raised seborrheic keratoses and several
clinical programs to develop medications for the potential
treatment of common warts, alopecia areata, and vitiligo. For
additional information, please visit www.aclaristx.com and follow
Aclaris on LinkedIn.
Cautionary Note Regarding Forward-Looking
Statements
Any statements contained in this press release that do not
describe historical facts may constitute forward-looking statements
as that term is defined in the Private Securities Litigation Reform
Act of 1995. These statements may be identified by words such as
“believe”, “expect”, “may”, “plan,” “potential,” “will,” and
similar expressions, and are based on Aclaris’ current beliefs and
expectations. These forward-looking statements include
expectations regarding Aclaris’ clinical development of A-101 45%
for the treatment of common warts, including the expected timing
for commencing a Phase 3 clinical trial. These statements involve
risks and uncertainties that could cause actual results to differ
materially from those reflected in such statements. Risks and
uncertainties that may cause actual results to differ materially
include uncertainties inherent in the conduct of clinical trials,
Aclaris’ reliance on third parties over which it may not always
have full control, risks associated with maintaining its
intellectual property portfolio and other risks and uncertainties
that are described in Aclaris’ Annual Report on Form 10-K for the
year ended December 31, 2017, and other filings Aclaris makes with
the SEC from time to time. These documents are available under the
“Financial Information” section of the Investors page of Aclaris’
website at http://www.aclaristx.com. Any forward-looking statements
speak only as of the date of this press release and are based on
information available to Aclaris as of the date of this release,
and Aclaris assumes no obligation to, and does not intend to,
update any forward-looking statements, whether as a result of new
information, future events or otherwise.
Contact:
Aclaris ContactMichael Tung, M.D. Investor
Relations484-329-2140mtung@aclaristx.com
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