Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led
biopharmaceutical company focused on immuno-inflammatory and
dermatological diseases, today announced positive results from a
Phase 2 open-label clinical trial of ATI-502 (AGA-201), an
investigational topical Janus Kinase (JAK) 1/3 inhibitor, in
patients with androgenetic alopecia (AGA), a condition commonly
known as male/female-pattern baldness.
The trial evaluated ATI-502 in women and men with AGA. Subjects
aged 18-50 years (n=31) applied ATI-502 to their scalp twice daily
for 26 weeks. Twenty-three subjects completed 6 months of
treatment. Twenty subjects (14 male, 6 female) had evaluable hair
counts, and twenty-two (15 male and 7 female) recorded investigator
global assessment (IGA) and subject self-assessment (SSA) scores.
The primary endpoint was the mean change from baseline in
non-vellus target area hair count (TAHC) at week 26. The
overall change was an increase of 8.6 hairs/cm2. TAHC increase was
15.3 hairs/cm2 in female subjects and 5.6 hairs/cm2 in male
subjects.
The secondary endpoints included an IGA and SSA. Subjects who
experienced increased hair growth were given a score of +1 or
better on the IGA and SSA (+1 = slightly increased hair growth, +2
= moderately increased hair growth, and +3 = greatly increased hair
growth). Based on these endpoints, investigators rated 73% of
subjects (16/22) as experiencing increased hair growth, and 82% of
subjects (18/22) rated themselves as experiencing increased hair
growth. ATI-502 was well-tolerated. There were no treatment-related
serious adverse events. There was one unrelated serious adverse
event of breast cancer reported, and one patient withdrew for
treatment-related alopecia in week one.
“The combination of the TAHC data, the investigator and subject
assessments, and our own internal review of the formal photography,
suggest topical JAK inhibition is a viable approach to treating
AGA,” said Dr. Neal Walker, President and Chief Executive Officer
of Aclaris. “This finding demonstrates that inhibiting a
non-hormonal and inflammatory-mediated pathway may be an option for
the treatment of AGA.”
“There has been no novel drug approved for the treatment of AGA
for decades. These data are encouraging and suggest ATI-502 may be
a potential treatment for patients with AGA – especially women,”
said Dr. Janet Roberts of Northwest Dermatology Institute,
Portland, Oregon, a Principal Investigator in the clinical
trial.
Next Steps:
- The 12-month results from this trial are expected by year end
2019.
- Through recent formulation work, Aclaris can achieve
significantly higher topical concentrations of ATI-502.
- As such, Aclaris believes the next step is initiating a
double-blind, randomized, controlled Phase 2 dose-ranging clinical
trial with higher concentrations of ATI-502, with potentially a
female focus, in the first half of
2020.
Company to Host Conference Call
Management will conduct a conference call at 8:00 AM ET today to
review these Phase 2 results and related matters. The
conference call will be webcast live over the Internet and can be
accessed by logging on to the “Investors” page of the Aclaris
Therapeutics website, www.aclaristx.com, prior to the event. A
replay of the webcast will be archived on the Aclaris Therapeutics
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 8887134 prior to the start of the
call.
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a physician-led biopharmaceutical
company committed to addressing the needs of people with
immuno-inflammatory and dermatological diseases who lack
satisfactory treatment options. The company’s diverse and
multi-stage portfolio includes two FDA-approved medicines, one
late-stage investigational medicine, and a pipeline powered by a
robust R&D engine exploring protein kinase regulation. Aclaris
Therapeutics’ active development programs focus on areas where
significant treatment gaps exist, such as common warts, alopecia
areata, and vitiligo. For additional information, please visit
www.aclaristx.com and follow Aclaris on LinkedIn or Twitter
@aclaristx.
About Androgenetic Alopecia
Androgenetic alopecia (AGA), also known as male pattern baldness
or female pattern hair loss, is the most common form of hair loss,
affecting approximately 50 million men and 30 million women in the
U.S.1,3 The condition may affect up to 70% of men and 40% of women,
beginning at some point in their adult lives.2 Male pattern
baldness usually involves hairline recession and balding of the
highest point of the head, while female pattern hair loss tends to
manifest as thinning hair over the top of the scalp.1,2
Susceptibility to AGA is largely determined by genetics, though
environmental factors may play a minor role.2 While AGA is
widespread, negative image perceptions make individuals with AGA
highly motivated to seek diagnosis and treatment.2 Currently
available treatment procedures can be invasive and costly and are
not optimal for some patients for various reasons, such as adverse
reactions and contraindications.
1 Ghanaat M. Types of Hair Loss and Treatment Options. South Med
J. 2010;103(9):917-921.
2 McElwee, K. J., & Shapiro, J. Promising Therapies for
Treating and/or Preventing Androgenic Alopecia.
https://www.skintherapyletter.com/alopecia/promising-therapies/.
Published June 1, 2012. Accessed May 13, 2019.
3 National Institutes of Health. Androgenetic alopecia.
https://ghr.nlm.nih.gov/condition/androgenetic-alopecia. Accessed
May 13, 2019.
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 the clinical development of its JAK inhibitor candidates,
including the availability of data from its ongoing clinical
trials, and 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 and in commercialization of products, 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, 2018, and other filings Aclaris makes
with the U.S. Securities and Exchange Commission from time to time.
These documents are available under the "SEC filings” 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 Contact
Michael Tung, M.D.Senior Vice PresidentCorporate
Strategy/Investor Relations484-329-2140mtung@aclaristx.com
Media Contact
Lauren Barbiero646-564-2156lbarbiero@w2ogroup.com
Aclaris Therapeutics (NASDAQ:ACRS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Aclaris Therapeutics (NASDAQ:ACRS)
Historical Stock Chart
From Apr 2023 to Apr 2024