New Analyses Presented on the Effect of
Baseline Severity and Duration of Current Episode of Hair Loss on
Scalp Hair Regrowth
Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced the
presentation of data from its THRIVE-AA1 Phase 3 clinical trial
during the 12th World Congress for Hair Research. The presentation
highlights THRIVE-AA1 study results evaluating Concert’s
investigational oral medicine deuruxolitinib (CTP-543) in adult
patients with moderate to severe alopecia areata, an autoimmune
disorder that results in patchy or complete scalp hair loss. The
World Congress presentation includes new analyses from THRIVE‑AA1
showing the effect of deuruxolitinib on regrowth of scalp hair
based on disease severity and duration of current episode of hair
loss. The data are being presented by Brett King, M.D., Department
of Dermatology, Yale University School of Medicine and clinical
investigator of THRIVE-AA1.
“These new data analyses are important to inform our treatment
of patients with varying degrees of disease severity and duration
of current episode of hair loss. For patients receiving
deuruxolitinib in THRIVE-AA1, the data show meaningful and
significant improvement in patients with the most severe disease
and those with longer duration of current episode. The data show,
however, that more patients succeed with treatment when they are
treated before they lose all of their scalp hair and when they are
treated earlier in an episode of severe loss” stated Dr. King.
In THRIVE-AA1, significant improvements in scalp hair regrowth
compared to placebo were achieved at 24 weeks for patients taking 8
mg twice-daily and 12 mg twice-daily doses of deuruxolitinib, as
previously disclosed in the positive topline results reported by
Concert earlier this year. Treatment with deuruxolitinib was
generally well tolerated.
The newly presented analyses on disease severity and duration of
current episode of hair loss from THRIVE‑AA1 include:
- For patients with an absolute Severity of Alopecia Tool (SALT)
score less than 95 at baseline, 43% and 57% of the 8 mg twice-daily
and 12 mg twice-daily deuruxolitinib dose groups, respectively,
achieved a SALT score of 20 or less at Week 24, compared to 1% of
patients in the placebo group (p<0.0001). The onset of effect
was significant as early as Week 8 for both doses
(p<0.001).
- For patients with a SALT score greater than or equal to 95
(representing complete or nearly complete scalp hair loss) at
baseline, 20% and 30% of the 8 mg twice-daily and 12 mg twice-daily
deuruxolitinib dose groups, respectively, achieved a SALT score of
20 or less at Week 24, compared to 0% of patients in the placebo
group (p<0.0001). The onset of effect was significant as early
as Week 12 for both doses (p<0.01).
- For patients whose duration of current episode of hair loss was
less than 4 years, the proportion of patients achieving a SALT
score of 20 or less by Week 24 was 33% and 48% in the
deuruxolitinib 8 mg twice-daily and 12 mg twice-daily dose groups,
respectively, compared to 1% of patients in the placebo group
(p<0.0001).
- For patients whose duration of current episode of hair loss was
greater than or equal to 4 years, the proportion of patients
achieving a SALT score of 20 or less by Week 24 was 23% and 29% in
the deuruxolitinib 8 mg twice-daily and 12 mg twice-daily dose
groups, respectively, compared to 0% of patients in the placebo
group (p<0.0001).
Deuruxolitinib was generally well-tolerated in THRIVE-AA1,
consistent with its other Phase 2 and Phase 3 studies. The most
common (≥5%) side effects in any dose group were headache, acne,
upper respiratory infection, increased creatine kinase levels,
COVID-19 infection and nasopharyngitis. Upper respiratory
infections were greater in the placebo group than in either of the
deuruxolitinib dose groups. No pulmonary embolisms or deep vein
thromboses were observed in the trial. One patient treated with the
8 mg twice-daily dose and one patient treated with the 12 mg
twice-daily dose developed herpes zoster (shingles). Serious
adverse events were reported in nine patients, with only one
patient (in the 8 mg twice-daily dose group) having events (2) that
were assessed as possibly related to treatment. Four patients who
reported serious adverse events were in the placebo group.
The data presented at the World Congress includes data recently
presented at the 31st European Academy of Dermatology and
Venereology (EADV) Congress late breaking news session. Details
from the World Congress oral presentation, entitled “Results from a
Phase 3 Trial, THRIVE-AA1, of the Oral JAK Inhibitor CTP-543
(Deuruxolitinib) in Adult Patients With Moderate to Severe Alopecia
Areata,” is available in the Scientific Presentations section of
Concert’s website.
About THRIVE-AA1
THRIVE-AA1 (NCT04518995) was a randomized, double-blind,
placebo-controlled clinical trial in 706 adult patients age 18-65
with moderate to severe alopecia areata at sites in the U.S.,
Canada and Europe evaluating the regrowth of scalp hair after 24
weeks of dosing using the SALT score. Patients were randomized to
receive either 8 mg twice-daily or 12 mg twice-daily of
deuruxolitinib or placebo for 24 weeks. The primary endpoint was
the percentage of patients achieving a SALT score of 20 or less at
24 weeks.
Patients enrolled in THRIVE-AA1 were required to have at least
50 percent scalp hair loss due to alopecia areata, as measured by
SALT. A SALT score of 100 represents total scalp hair loss, whereas
a score of 0 represents no scalp hair loss. The average baseline
SALT score across all patients in THRIVE-AA1 was approximately 85.9
(corresponding to less than 15% average scalp hair coverage).
All patients who completed 24 weeks of treatment in THRIVE-AA1
had the opportunity to continue in a separate extension study to
evaluate long-term safety and efficacy of deuruxolitinib. More than
95% of eligible patients in THRIVE-AA1 elected to roll into the
extension study.
In THRIVE-AA1, significant improvements in scalp hair regrowth
compared to placebo were achieved at 24 weeks for patients taking 8
mg twice-daily and 12 mg twice-daily doses of deuruxolitinib.
Treatment with deuruxolitinib was generally well tolerated.
About Deuruxolitinib and Alopecia Areata
Deuruxolitinib (CTP-543) is an investigational oral selective
inhibitor of Janus kinases JAK1 and JAK2. The Food and Drug
Administration has granted deuruxolitinib Breakthrough Therapy
designation for the treatment of adult patients with moderate to
severe alopecia areata and Fast Track designation for the treatment
of alopecia areata.
Alopecia areata is an autoimmune disease in which the immune
system attacks hair follicles, resulting in partial or complete
loss of hair on the scalp and body. Alopecia areata may affect up
to approximately 1.5 million Americans at any given time.1 The
scalp is the most commonly affected area, but any hair-bearing site
can be affected alone or together with the scalp. Onset of the
disease can occur throughout life and affects both women and men.
Alopecia areata can be associated with serious psychological
consequences, including anxiety and depression. There are currently
limited treatment options available for alopecia areata.
About Concert
Concert Pharmaceuticals is a late-stage clinical
biopharmaceutical company that is developing deuruxolitinib, a
novel, deuterated, oral JAK1/2 inhibitor. Concert has successfully
completed two Phase 3 trials with deuruxolitinib in adults with
alopecia areata, a serious autoimmune dermatological disease. The
Company is also evaluating the use of deuruxolitinib in other
indications and assessing a number of earlier-stage pipeline
candidates. For more information, please visit
www.concertpharma.com or follow us on Twitter, Instagram or
LinkedIn.
Cautionary Note on Forward Looking Statements
Any statements in this press release about our future
expectations, plans and prospects, including, among others,
statements about our expectations regarding the development of
deuruxolitinib, and any other statements containing the words
“anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,”
“intend,” “may,” “plan,” “potential,” “predict,” “project,”
“should,” “target,” “will,” “would” and similar expressions,
constitute forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. Actual results
may differ materially from those indicated by such forward-looking
statements as a result of various important factors, including: the
uncertainties inherent in the initiation, timing and design of
future clinical trials, the availability and timing of data from
ongoing and future clinical trials and the results of such trials,
whether preliminary results, including safety profiles, from a
clinical trial will be predictive of the final results of that
trial or whether results of early clinical trials will be
indicative of the results of later clinical trials, expectations
for the timing of the submission of a New Drug Application, the
availability of regulatory approvals and other factors discussed in
the “Risk Factors” section of our most recent Quarterly Report on
Form 10-Q filed with the Securities and Exchange Commission and in
other filings that we make with the Securities and Exchange
Commission. In addition, any forward-looking statements included in
this press release represent our views only as of the date of this
release and should not be relied upon as representing our views as
of any subsequent date. We specifically disclaim any obligation to
update any forward-looking statements included in this press
release.
1 Benigno M. Clinical, Cosmetic and Investigational Dermatology
2020
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version on businesswire.com: https://www.businesswire.com/news/home/20221121005046/en/
For additional information contact: Justine Koenigsberg
(investors) Concert Pharmaceuticals, Inc. (781) 674-5284
ir@concertpharma.com
Kathryn Morris (media) The Yates Network (914) 204-6412
kathryn@theyatesnetwork.com
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