Cara Therapeutics Presents Late-Breaking Results of KARE Phase 2 Trial of Oral Difelikefalin (Oral KORSUVA™) in Atopic Dermatitis Patients with Moderate-to-Severe Pruritus at the 2021 European Academy of Dermatology and Venereology (EADV) Virtual Congres
October 04 2021 - 7:00AM
Cara Therapeutics, Inc. (Nasdaq: CARA), a biopharmaceutical
company focused on developing and commercializing new chemical
entities designed to alleviate pruritus by selectively targeting
peripheral kappa opioid receptors, presented results from the KARE
Phase 2 clinical trial of oral difelikefalin for the treatment of
moderate-to-severe pruritus in mild-to-severe atopic dermatitis
(AD) patients. Results were presented by Brian Kim, MD, Associate
Professor of Dermatology and Co-Director of the Center for the
Study of Itch and Sensory Disorders at Washington University School
of Medicine, during the Late Breaking News session of the 2021
European Academy of Dermatology and Venereology (EADV) Virtual
Congress on October 2, 2021.
The presentation summarized data from 401 subjects with AD and
moderate-to-severe pruritus, who were randomized to receive oral
difelikefalin at a dose of 0.25 mg, 0.5 mg or 1.0 mg, or placebo
over a 12-week treatment period.
Subjects with mild-to-moderate AD were included in a
prespecified analysis. Approximately 64% of subjects had
BSA<10 and the results of this “Itch Dominant AD” subgroup were
presented.
In addition, a mouse model of AD was used to test the effects of
difelikefalin on itch and lesion severity.
Although the primary endpoint, change from baseline in Itch
Numerical Rating Scale (I-NRS) score, was not met with any of the
difelikefalin dose groups in the overall population, a significant
improvement (p= 0.039) in itch was observed at week 12 in the
combined difelikefalin dose group in subjects with BSA <10%. In
this subpopulation of itch-dominant AD, significant reduction in
itch with difelikefalin was evident as early as day 2. In addition,
a significantly greater proportion of subjects (32% vs 19%;
p<0.05) in the combined difelikefalin dose group versus placebo
achieved a ≥4-point improvement in I-NRS at week 12 (the required
regulatory primary endpoint for Phase 3 pruritus programs).
Difelikefalin was well-tolerated, with most adverse events (~95%)
being mild or moderate in severity. The most commonly reported
adverse events included abdominal pain, nausea, dry mouth,
headache, dizziness, and hypertension. In the mouse model of AD, a
rapid and significant anti-pruritic effect of difelikefalin was
observed independently of effects on skin inflammation.
“Patients with mild-to-moderate AD commonly exhibit
moderate-to-severe pruritus which is inadequately addressed by
available topical medications,” said Dr. Kim. “Together, the
results of the KARE clinical study and the AD mouse model support
the role of difelikefalin as a potential novel, systemic
antipruritic agent that may effectively address pruritus in
patients with itch-dominant AD.”
About Cara Therapeutics
Cara Therapeutics is a clinical-stage
biopharmaceutical company focused on developing and commercializing
new chemical entities designed to alleviate pruritus by selectively
targeting peripheral kappa opioid receptors, or KORs. Cara is
developing a novel and proprietary class of product candidates, led
by KORSUVA™ (CR845/difelikefalin), a first-in-class KOR agonist
that targets the body’s peripheral nervous system, as well as
certain immune cells. KORSUVA Injection was approved by the U.S.
Food and Drug Administration (FDA) for the treatment of
moderate-to-severe pruritus associated with chronic kidney disease
(CKD-aP) in adults undergoing hemodialysis on August 23, 2021. Oral
KORSUVA has completed Phase 2 trials for the treatment of pruritus
in patients with CKD and atopic dermatitis and is currently in
Phase 2 trials in primary biliary cholangitis and notalgia
paresthetica patients with moderate-to-severe pruritus.
Forward-looking Statements
Statements contained in this press release
regarding matters that are not historical facts are
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. Examples of these
forward-looking statements include statements concerning the future
development of Oral KORSUVA for pruritus in patients with
mild-to-moderate atopic dermatitis and the potential for Oral
KORSUVA to treat these patients. Because such statements are
subject to risks and uncertainties, actual results may differ
materially from those expressed or implied by such forward-looking
statements. Risks are described more fully in Cara Therapeutics’s
filings with the Securities and Exchange Commission, including
the "Risk Factors" section of Cara Therapeutic’s Annual Report on
Form 10-K for the year ended December 31, 2020 and its other
documents subsequently filed with or furnished to
the Securities and Exchange Commission. All forward-looking
statements contained in this press release speak only as of the
date on which they were made. Except to the extent required by law,
Cara Therapeutics undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made.
MEDIA CONTACT:Claire LaCagnina6
Degrees315-765-1462clacagnina@6degreespr.com
INVESTOR CONTACT:Janhavi MohiteStern Investor
Relations, Inc.212-362-1200janhavi.mohite@SternIR.com
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