Aclaris Therapeutics Announces Phase 2 Clinical Trial of ATI-501 Oral in Patients with Alopecia Areata Met Primary Endpoint
July 30 2019 - 4:01PM
Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led
biopharmaceutical company focused on immuno-inflammatory and
dermatological diseases, today announced results from its Phase 2
clinical trial of ATI-501 (AUAT-201 Oral), an investigational oral
Janus Kinase (JAK) 1/3 inhibitor, in subjects with alopecia areata
(AA). Subjects treated with ATI-501 achieved statistically
significant improvement over placebo in several measures of hair
growth, including the primary endpoint and certain secondary
endpoints of the trial.
AUAT-201 Oral, a Phase 2 randomized, double-blinded,
parallel-group, placebo-controlled trial, evaluated the safety,
efficacy, and dose response of three doses of ATI-501 on the
regrowth of hair in 87 subjects with AA, including Patchy Alopecia,
Alopecia Totalis, and Alopecia Universalis. Subjects with 30%
to 100% total scalp hair loss were randomized in a 1:1:1:1 ratio
and received 24 weeks of treatment, twice daily, with either 400
mg, 600 mg or 800 mg of ATI-501 or a placebo oral suspension.
The primary endpoint of the trial was the mean percent change
from baseline in the Severity of Alopecia Tool (SALT) score at week
24. Subjects in each of the three ATI-501 active dose groups
(400 mg, 600 mg, and 800 mg) had statistically significant
improvements compared to placebo for the primary endpoint (p=0.011,
p=0.001, and p=0.010, respectively).
Secondary endpoints for which subjects in all three active
treatment arms of the trial also achieved statistically significant
improvements at 24 weeks compared to placebo included the
following:
- Absolute change in SALT scores from baseline: p<0.05 for all
three ATI-501 doses;
- Alopecia Density and Extent (ALODEX) percent change from
baseline: p<0.05 for all three ATI-501 doses; and
- ALODEX absolute change from baseline: p<0.01 for all three
ATI-501 doses
Other exploratory secondary endpoints which were assessed were
not statistically significant compared to placebo.
ATI-501 was observed to be generally well-tolerated at all
doses. There were no serious adverse events reported. All
adverse events (AEs) were mild or moderate in severity and rates of
AEs were similar across all groups. No thromboembolic events were
observed in the study. The most common AEs across all
groups were: nasopharyngitis, influenza, upper respiratory tract
infection, urinary tract infection, acne, blood creatine
phosphokinase increased, and sinusitis. Two subjects in each
of the placebo and 400 mg groups and one subject in the 600 mg
group had AEs leading to discontinuation of study drug, with no
such AEs in the 800 mg group.
“We are pleased with these results, and we thank the patients
and the investigators who participated in this trial,” said Dr.
David Gordon, the Chief Medical Officer of Aclaris.
Company to Host Conference Call
Management will conduct a conference call at 5:00 PM 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 2069789 prior to the start of the
call.
About Alopecia Areata
Alopecia Areata (AA) is an autoimmune dermatologic condition
typically characterized by patchy non-scarring hair loss on the
scalp and body. More severe forms of AA include total scalp
hair loss, known as alopecia totalis, and total hair loss on the
scalp and body, known as alopecia universalis. The scalp is
the most commonly affected area. Onset of AA may occur in childhood
and most patients experience onset by age 40. The course of disease
is unpredictable and may involve spontaneous hair regrowth and
sudden hair loss. Over half of patients with AA experience poor
health-related quality of life. The disease can be associated with
serious psychological consequences, including anxiety and
depression. AA affects up to 1.8% of people in the United States
and 2.0% of people globally at some point during their lives.
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.
Aclaris ContactMichael Tung, M.D.Senior Vice PresidentCorporate
Strategy/Investor Relations484-329-2140mtung@aclaristx.com
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