35 Percent of Patients Treated With CTP-543 12
mg Twice-Daily Achieved At Least 90 Percent Scalp Hair Coverage
(SALT Score ≤ 10) After 24 Weeks of Treatment
Newly-Reported Results Show Significant
Improvement in Eyebrow and Eyelash Regrowth in Patients Treated
With Both Doses of CTP-543
Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced the
presentation of data from its Phase 3 clinical trial, THRIVE-AA1.
The presentation highlights THRIVE-AA1 study results evaluating
Concert’s oral investigational medicine CTP-543 in adult patients
with moderate to severe alopecia areata, an autoimmune disorder
that results in patchy or complete scalp hair loss. The THRIVE-AA1
data are being presented by Brett King, M.D., Department of
Dermatology, Yale University School of Medicine and clinical
investigator of THRIVE-AA1, during the 31st European Academy of
Dermatology and Venereology (EADV) Congress Late Breaking News
Session.
In the THRIVE-AA1 study, 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 CTP-543, as
previously disclosed in the positive topline results reported by
Concert earlier this year. Treatment with CTP-543 was generally
well tolerated. The EADV presentation includes new data from the
THRIVE‑AA1 study showing the ability of CTP-543 to achieve more
stringent criteria for hair regrowth than the study’s primary
endpoint of absolute Severity of Alopecia Tool (SALT) score of 20
or less (meaning 20 percent or less scalp hair loss) at Week 24.
Specifically, 21 percent and 35 percent of the patients in the
CTP-543 8 mg twice-daily and 12 mg twice-daily dose groups,
respectively, achieved a SALT score of 10 or less at Week 24,
compared to 0 percent of patients in the placebo group
(p<0.0001). Also, the relative change in SALT score from
baseline was significantly different for the 12 mg twice-daily dose
group compared to placebo (p<0.001) as early as Week 4. In
addition, new data are presented showing that patients in the
THRIVE-AA1 study with loss of eyebrow or eyelash hair at baseline
treated with CTP-543 had significant improvement compared to
placebo over the 24-week treatment period (p<0.001).
“In the Phase 3 results to date, CTP-543 has hit the mark with
the primary endpoint of SALT score of 20 or less, which is
clinically meaningful scalp hair regrowth for patients with
alopecia areata. It is notable that the majority of patients who
achieve the primary endpoint achieve the more stringent endpoint of
SALT score of 10 or less in the THRIVE‑AA1 study,” stated Dr. King.
“These data are highly encouraging and support the potential of
CTP-543 to regrow hair on the scalp, eyebrows and eyelashes in
patients with alopecia areata, and in many cases with a rapid onset
of effect.”
“Based on the strength of the THRIVE-AA clinical program data,
CTP-543 has the potential to be a best-in-class treatment for
alopecia areata,” stated James V. Cassella, Ph.D., Chief
Development Officer at Concert Pharmaceuticals. “Alopecia areata is
a serious autoimmune disorder that has a strong association with
emotional and psychosocial impact on patients’ lives. We hope that
CTP-543 has the potential to bring broader benefit to alopecia
areata patients and plan to file a New Drug Application for CTP-543
in the first half of 2023.”
The Phase 3 data presented at EAVD include a comprehensive
review of the THRIVE-AA1 results and are consistent with the
topline data reported in May 2022 by Concert:
- The primary efficacy endpoint for THRIVE-AA1 was the percentage
of patients achieving an absolute SALT score of 20 or less at Week
24 of treatment, which was met with statistical significance in
both the 8 mg twice-daily and 12 mg twice-daily dose groups
relative to placebo. A statistically significant proportion of
patients treated with either 8 mg twice-daily or 12 mg twice-daily
of CTP-543 experienced greater scalp regrowth compared to placebo.
The proportion of patients achieving a SALT score of 20 or less at
Week 24 was 41.5 percent in the 12 mg twice-daily dose group and
29.6 percent in the 8 mg twice-daily dose group, compared to 0.8
percent of patients in the placebo group. The treatment difference
for both dose groups of CTP-543 relative to placebo was
statistically significant (p<0.0001). In addition, 21 percent
and 35 percent of the patients in the CTP-543 8 mg twice-daily and
12 mg twice-daily dose groups, respectively, achieved a SALT score
of 10 or less at Week 24 compared to 0 percent of patients in the
placebo group (p<0.0001).
- THRIVE-AA1 also met all the key secondary endpoints at both
doses of CTP-543. The key secondary endpoints were the percentage
of responders on a Satisfaction of Hair Patient Reported Outcome
(SPRO) scale at Week 24 and the percentage of patients achieving
absolute SALT scores of 20 or less at each of Weeks 20, 16, 12 and
8. All key secondary endpoints were met with statistical
significance in both dose groups.
- The safety profile seen with CTP-543 in THRIVE-AA1 was
consistent with previous 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 CTP-543 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.
Details from the oral presentation, entitled “Top-Line Results
from THRIVE-AA1: A Phase 3 Clinical Trial of CTP-543
(deuruxolitinib), an Oral JAK Inhibitor, 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 CTP-543 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 CTP-543. More than 95% of
eligible patients in THRIVE-AA1 elected to roll into the extension
study.
About CTP-543 and Alopecia Areata
CTP-543 is an investigational oral selective inhibitor of Janus
kinases JAK1 and JAK2. The FDA has granted CTP-543 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 CTP-543, a novel oral
JAK1/2 inhibitor. Concert has successfully completed two Phase 3
trials with CTP-543 in adults with alopecia areata, a serious
autoimmune dermatological condition. The Company is also evaluating
the use of CTP-543 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 at
@ConcertPharma or on 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
CTP-543, the potential for CTP-543 to be a best-in-class treatment
for the treatment of alopecia areata and the planned timing for
filing a New Drug Application (NDA) for CTP-543, 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 an NDA,
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/20220910005007/en/
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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