Aclaris Therapeutics Announces First Patient Dosed in Phase 3 Studies Evaluating A-101 45% in Patients with Common Warts
September 24 2018 - 7:00AM
Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led
biopharmaceutical company committed to identifying, developing, and
commercializing innovative therapies to address significant unmet
needs in aesthetic and medical dermatology and immunology, today
announced the initiation of a Phase 3 wart program evaluating A-101
(hydrogen peroxide) topical solution 45% (A-101 45%) in patients
with common warts. The program consists of the THWART-1 and
THWART-2 pivotal studies and will include a long term safety
extension study.
“Common warts are a ubiquitous dermatological
complaint and a frequent reason for physician visits. These
lesions can be persistent, irritating, uncomfortable, and are
associated with a social stigma,” said Dr. David Gordon, Chief
Medical Officer of Aclaris. “Additional therapeutic options are
needed to safely and effectively manage this skin condition. Based
on positive data in our Phase 2 studies in common warts, we look
forward to further evaluating A-101 45% in a Phase 3 program.”
THWART-1 and THWART-2
Studies
These Phase 3, multicenter, double-blind,
randomized, vehicle-controlled, studies will evaluate the safety
and efficacy of A-101 45% topical solution compared with vehicle
(placebo) in patients with common warts. Investigators will
identify and treat up to 6 common warts with A-101 45% study
medication or vehicle. All identified common warts will be treated
twice a week for up to 8 weeks for a total of up to 16 treatments,
and patients will be followed for 12 weeks post the final
treatment. The studies are expected to enroll approximately 1000
patients, ages two years and older.
The primary objective of these studies is to
evaluate the effectiveness of A-101 45% compared to vehicle in
treating common warts. The secondary objectives of these studies
include assessing the duration of response, the onset of action,
and the safety of A-101 45%.
About Common Warts
Common warts, also called verruca vulgaris,
affect more than 22 million Americans. Prevalence is higher in
children than in 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, such as salicylic acid topicals, 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. Existing in-office treatment procedures are often
painful or invasive, can have undesirable outcomes like scarring or
dyspigmentation, and often require repeat visits.
About A-101 45%
A-101 45% topical solution, an investigational
drug for the treatment of common warts, is a proprietary
formulation of hydrogen peroxide. It is being developed as a
topical, non-invasive treatment for self-administration or
administration by a caregiver.
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 its drug candidates, including the timing for
initiation of planned clinical trials. 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 filed for the year ended December 31, 2017, Aclaris’
Quarterly Report on Form 10-Q filed earlier for the quarter ended
June 30, 2018 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.
Aclaris ContactMichael Tung, M.D.Senior Vice
President Corporate Strategy/Investor
Relations484-329-2140mtung@aclaristx.com
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