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2016-11-15

Aclaris Therapeutics, Inc.: Aclaris Therapeutics Announces Positive Top-Line Phase 3 Results for A-101 In Treating Seborrheic Keratosis, a Common Undertreated S

* 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.

The secondary endpoint of both trials was the percentage of patients treated
with A-101 who achieved clearance (PLA=0) of at least three of the four
target SK lesions. In the SEBK-301 trial, 13.5% of patients treated with
A-101 achieved clearance of at least three of the four target SK lesions
(p<0.0001); in the SEBK-302 trial, 23.0% of treated patients achieved
clearance of at least three of the four target SK lesions (p<0.0001). None
of the patients treated with placebo achieved this endpoint. Clearance of
three out of four target lesions is the primary endpoint that Aclaris has
agreed upon with European Union (EU) regulators as a basis for approval.
Based on these results, Aclaris plans to submit a Marketing Authorization
Application in the EU in mid-2017.

An ancillary endpoint was the mean per-patient percentage of target lesions
treated with A-101 who achieved clear or near clear of all target SK lesions
(PLA<1). In SEBK-301, 47.5% of patients treated with A-101 achieved clear or
near clear versus placebo which was 10.2% (p<0.0001). In SEBK-302, 54.3% of
patients treated with A-101 achieved clear or near clear versus placebo which
was 4.7% (p<0.0001).

"I see many SK patients who lack confidence in their appearance, especially
those who have lesions in visible areas such as the face and neck," said
trial investigator Zoe Draelos, M.D., board-certified dermatologist, fellow
of the American Academy of Dermatology. "For patients who seek to improve
their appearance, a treatment that can achieve clearance or near clearance of
lesions while delivering a favorable aesthetic result would represent a
significant advance in the standard of SK treatment."

SK lesions are common, non-cancerous skin lesions that impact more than 83
million Americans and frequently appear in highly visible locations such as
the face or neck. The lesions are typically characterized by a waxy, scaly,
elevated appearance and can vary in color from light tan to dark brown or
black. SK lesions can have an adverse physical and emotional impact on
patients. Existing treatments are invasive, often painful, or have
undesirable outcomes like scarring or dyspigmentation.

"We are extremely pleased by these top-line results," said Aclaris President
and Chief Executive Officer Dr. Neal Walker. "We had a productive pre-NDA
meeting with the U.S. Food and Drug Administration earlier this year and look
forward to submitting a New Drug Application to the FDA in the first quarter
of 2017. We are committed to bringing this important new treatment to
patients and their physicians." If approved, A-101 would be the first
FDA-approved topical treatment for SK.

Safety Results

There were no treatment-related serious adverse events among patients treated
with A-101. The most common adverse events were nasopharyngitis and
sinusitis which were determined to be unrelated to A-101.

Local skin reactions, if present, were predominantly classified as mild. The
rates of hypopigmentation, hyperpigmentation, and scarring classified as
greater than mild were less than one percent in all groups in both trials.

Additionally, Aclaris announced that initial safety results from an open-label
safety trial of A-101 (SEBK-303) were consistent with the SEBK-301 and
SEBK-302 trials. The SEBK-303 trial enrolled 147 patients at 10 sites across
the United States.

"This safety profile in these trials is compelling since there has been a
significant need for an effective, non-invasive SK treatment without
long-term pigmentary changes," said Dr. Walker.

Aclaris plans to present this data at a future medical meeting and also for
consideration for publication in a peer-reviewed journal.

Management will conduct a conference call at 5:00 PM ET on November 15, 2016
to discuss these results. The conference will be webcast live over the
Internet and can be accessed by logging on to the "Investors" section of the
Aclaris Therapeutics website, www.aclaristx.com, prior to the event. A
replay of the webcast will be archived on the Company's website for 30 days
following the call.

To participate on the live call, please dial (844) 776-7782 (domestic) or
(661) 378-9535 (international), and reference conference ID 21069052 prior to
the start of the call.

About A-101
A-101 (40% topical solution) is a proprietary, high-concentration hydrogen
peroxide formulation in late-stage development for the treatment of
seborrheic keratosis (SK). It is being developed as a non-invasive, in-office
therapy, able to be administered by physicians or non-physician health care
providers. In clinical trials, A-101 showed statistically and clinically
significant results in clearing SK lesions with an adverse event profile
similar to placebo. A-101 is designed to work by penetrating into the SK
lesion and causing oxidative damage, which can ultimately result in the
sloughing of the SK cells. A-101 has been the focus of a robust clinical
development program in which over 700 patients have been treated with A-101.
Aclaris plans to submit a New Drug Application (NDA) for A-101 in the first
quarter of 2017. If approved, A-101 would be the first FDA-approved topical
treatment for SK. A higher concentration of A-101 is also in clinical
development for the treatment of common warts (verruca vulgaris).

About Seborrheic Keratosis
Seborrheic keratosis (SK) is a skin condition that affects more than 83
million Americans and is characterized by non-cancerous lesions with a waxy,
scaly, slightly elevated appearance that can vary in color from light tan to
dark brown or black. SK lesions frequently appear in highly visible
locations, such as the face or neck, and can have an adverse physical and
emotional impact on people who have them. SK sufferers may be affected with
just one lesion or dozens and often have a family history of SK. Prevalence
of SK increases with advancing age and over three-quarters of patients
seeking treatment from dermatologists are aged 40 to 69. SK is one of the
most frequent diagnoses made by dermatologists, yet it remains undertreated.
There are currently no FDA-approved medications for SK, and existing
treatment procedures are often painful, invasive and can have undesirable
outcomes like scarring or dyspigmentation.

About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a clinical-stage dermatologist-led
pharmaceutical company focused on identifying, developing and commercializing
innovative and differentiated therapies to address significant unmet needs in
medical and aesthetic dermatology. Aclaris is based in Malvern, Pennsylvania.

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 and potential commercialization of
A-101 for the treatment of SK and 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, and other risks and uncertainties that
are described in the Risk Factors section of Aclaris' Annual Report on Form
10-K for the year ended December 31, 2015, Aclaris' Quarterly Report on Form
10-Q for the quarter ended September 30, 2016, and other filings Aclaris
makes with the U.S. Securities and Exchange Commission 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.

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