Cara Therapeutics Completes Full Enrollment in KARE Phase 2 Trial of Oral KORSUVA™ in Atopic Dermatitis Patients with Moder...
December 02 2020 - 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, or KORs, today announced that it has
completed full enrollment of its KARE Phase 2 dose-ranging clinical
trial of Oral KORSUVA™ (difelikefalin tablets) for the treatment of
moderate-to-severe pruritus in atopic dermatitis patients. The
trial has enrolled 400 patients at multiple clinical sites across
the United States (US).
“Full enrollment of the KARE Phase 2 trial on
schedule represents an important milestone for the clinical
development of Oral KORSUVA. We look forward to reporting topline
data from this trial in early 2021,” said Derek Chalmers, Ph.D.,
D.Sc., President and Chief Executive Officer of Cara Therapeutics.
“Pruritus treatment continues to be a significant unmet need for
patients with atopic dermatitis and we believe Oral KORSUVA has the
potential to be a first-in-class oral anti-pruritic product with a
favorable safety profile.”
KARE Phase 2 Trial
Design
The KARE Phase 2 trial is a randomized,
double-blind, placebo-controlled study that is designed to evaluate
the efficacy and safety of Oral KORSUVA for moderate-to-severe
pruritus in approximately 400 adult subjects with atopic
dermatitis. Subjects were randomized to three tablet strengths of
Oral KORSUVA: 0.25 mg, 0.5 mg and 1 mg taken twice daily (BID)
versus placebo for 12 weeks followed by 4 weeks of an active
extension phase.
KARE’s primary efficacy endpoint is change from
baseline in the weekly mean of the daily 24-hour Itch NRS score at
week 12 of the treatment period. The key secondary endpoint for
KARE is the assessment of the proportion of patients achieving an
improvement from baseline of ≥4 points with respect to the weekly
mean of the daily 24-hour Itch NRS score at week 12. Itch-related
quality of life scores at the end of week 12 are assessed by the
total Skindex-10 and 5-D itch scales.
A prespecified interim conditional power
assessment, conducted after approximately 50% of the originally
targeted patient number completed the designated 12-week treatment
period, was completed in the second quarter of this year. Based on
the Independent Data Monitoring Committee’s (IDMC) recommendation,
the size of the KARE trial was increased by approximately 28%, from
an original enrollment target of 320 patients to approximately 400
patients, to maintain the prespecified statistical power of 80
percent or greater on the trial’s primary and key secondary
endpoints of change from baseline in the weekly mean of the daily
24-hour Itch Numeric Rating Scale (Itch NRS) and proportion of
patients achieving a >4 point improvement in Itch NRS score at
week 12, respectively.
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. In two Phase 3 trials, KORSUVA Injection has
demonstrated statistically significant reductions in itch intensity
and concomitant improvement in quality of life measures in
hemodialysis patients with moderate-to-severe chronic kidney
disease-associated pruritus (CKD-aP). Oral KORSUVA has successfully
completed a Phase 2 trial for the treatment of pruritus in patients
with CKD and is currently in Phase 2 trials in atopic dermatitis
and primary biliary cholangitis patients with moderate-to-severe
pruritus.
The FDA has conditionally accepted KORSUVA™ as
the trade name for difelikefalin injection. CR845/difelikefalin is
an investigational drug product and its safety and efficacy have
not been fully evaluated by any regulatory authority.
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
ongoing trials, including the timing for reporting topline data,
future development of Oral KORSUVA for pruritus in patients with
atopic dermatitis and the potential for Oral KORSUVA to be a
first-in-class anti-pruritic product with a favorable safety
profile for 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's filings with
the Securities and Exchange Commission, including the "Risk
Factors" section of Cara's Quarterly Report on Form 10-Q for the
quarter ended September 30, 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 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: Annie Starr6 Degrees973-415-8838
astarr@6degreespr.com
INVESTOR CONTACT:Janhavi MohiteStern Investor
Relations, Inc.janhavi.mohite@SternIR.com
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