Aclaris Therapeutics’ A-101 45% Topical Solution Meets Primary and All Secondary Endpoints in Two Phase 2 Clinical Trials f...
January 08 2018 - 7:00AM
Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led
biopharmaceutical company focused on identifying, developing and
commercializing innovative and differentiated therapies to address
significant unmet needs in medical and aesthetic dermatology, today
announced positive results from its two Phase 2 clinical trials
(WART-202 and WART-203) of A-101 45% topical solution (A-101 45%),
an investigational new drug for the treatment of common warts
(verruca vulgaris). A-101 45% met all primary and secondary
endpoints of each trial, achieving clinically and statistically
significant clearance of common warts. A-101 45% is a proprietary
high-concentration hydrogen peroxide topical solution being
developed as a prescription treatment for common warts.
Both trials evaluated the safety and efficacy of A-101 45% as
compared to placebo (vehicle). The two randomized, double-blind,
vehicle-controlled trials were designed to understand the effects
of dose frequency and to explore additional clinical endpoints that
will be further evaluated in a planned Phase 3 development
program.
The WART-203 trial evaluated 159 patients who self-administered
either A-101 45% or placebo twice weekly through Day 56, for a
total of 16 treatments. Each patient had between one and six warts
at baseline. The trial achieved its primary endpoint, which was
mean change from baseline in the Physician’s Wart Assessment (PWA)
scale score at Day 56 (Visit 10 or one week after the last
treatment). The PWA score is a four-point scale of the
investigators’ assessment of the severity of a target wart at a
particular time point.
- The mean reduction in PWA score at Day 56 on the target warts
was 0.87 points in patients who received A-101 45%, compared to a
reduction of 0.17 points for the target warts that received
placebo, a result that was statistically significant
(p<0.001).
Secondary endpoints of the WART-203 trial:
- The percentage of all treated warts that were clear (PWA = 0)
at Day 56 was 30.20% in patients who received A-101 45%, compared
to 9.22% among patients in the placebo group (p<0.001).
- The percentage of all treated warts that were clear or
near-clear (PWA <= 1) at Day 56 was 45.64% among patients who
received A-101 45%, compared to 15.60% among patients in the
placebo group (p<0.001).
- The proportion of patients achieving target wart clearance at
Day 56 was 25.32% among those who received A-101 45%, compared to
2.56% among patients in the placebo group (p<0.0001).
- The proportion of patients with all treated wart(s) clear at
Day 56, stratified by the baseline number of warts treated (1-6),
was 18.99% among those who received A-101 45%, compared to 2.56%
among patients in the placebo group (P=0.001).
The WART-202 trial evaluated 157 patients who self-administered
either A-101 45% or placebo once weekly through Day 56, for a total
of 8 treatments. Each patient had between one and four warts at
baseline. The trial achieved its primary endpoint, which was mean
change from baseline in the PWA score of the target wart at Day 56
(one week after the last treatment).
- The mean reduction in PWA score at Day 56 on the target warts
was 0.77 points in patients who received A-101 45%, compared to a
reduction of 0.23 points for the target warts that received
placebo, a result that was also statistically significant
(p<0.001).
Secondary endpoints of the WART-202 trial:
- The percentage of all treated warts that were clear at Day 56
was 20.75% in patients who received A-101 45%, compared to 2.94%
among patients in the placebo group (p<0.001).
- The percentage of all treated warts that were clear or
near-clear at Day 56 was 52.83% among patients who received A-101
45%, compared to 13.73% among patients in the placebo group
(p<0.001).
- The proportion of patients achieving target wart clearance at
Day 56 was 15.71% among those who received A-101 45%, compared to
1.37% among patients in the placebo group (p<0.001).
- The proportion of patients with all treated wart(s) clear at
Day 56, stratified by the baseline number of warts treated (1-4),
was 11.43% among those who received A-101 45%, compared to 1.37%
among patients in the placebo group (P=0.01).
Patients in both of the WART-202 and WART-203 trials are
continuing in a 3-month open-label drug-free follow-up evaluation
to assess the durability of clinical effect.
Safety Results
- There were no treatment-related serious adverse events among
patients treated with A-101 45%.
- A-101 45% was well tolerated through visit 10 (Day 56).
“We are extremely pleased by these results,” said Dr. Neal
Walker, President and CEO of Aclaris. “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
focused on identifying, developing and commercializing innovative
and differentiated therapies to address significant unmet needs in
medical and aesthetic dermatology. Aclaris is focused on
large, undertreated market segments with no FDA-approved
medications or where treatment gaps exist. Aclaris is based
in Malvern, Pennsylvania and more information can be found by
visiting the Aclaris website at www.aclaristx.com.
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. 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, 2016, Aclaris’ Quarterly Report on Form
10-Q for the quarter ended September 30, 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
Media ContactMariann
CaprinoTogoRun917-242-1087M.Caprino@togorun.com
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