Cara Therapeutics Announces Completion of Interim Statistical Assessment for KARE Phase 2 Trial of Oral KORSUVA™ in Atopic ...
June 17 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 the completion of
a planned sample size re-estimation of its KARE Phase 2
dose-ranging trial of Oral KORSUVA for the treatment of
moderate-to-severe pruritus in atopic dermatitis patients.
Based on the Independent Data Monitoring
Committee’s (IDMC) recommendation, KARE’s trial size will be
increased by approximately 28%, from an original enrollment target
of 320 patients to 410 patients, to maintain the prespecified
statistical power of 80 percent or greater on the trial’s primary
endpoint of change from baseline in the weekly mean of the daily
24-hour Itch Numeric Rating Scale (Itch NRS) and key secondary
endpoint of proportion of patients achieving a >4 point
improvement in Itch NRS score at week 12. The IDMC’s recommendation
was based on the results of a prespecified interim conditional
power assessment conducted after approximately 50% of the
originally targeted patient number completed the designated 12-week
treatment period.
“We are pleased with this IDMC recommendation
that, with a modest increase in target patient enrollment,
keeps us on track for our trial’s conservative statistical power
goals for the key secondary >4-point responder endpoint, which
is the accepted clinically meaningful endpoint for regulatory
approval of therapeutics for pruritic dermatological indications,”
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
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 410 adult subjects with atopic
dermatitis. Subjects are randomized to three tablet strengths of
Oral KORSUVA: 0.25mg, 0.5mg and 1mg taken twice daily (BID) versus
placebo for 12 weeks followed by 4 weeks of an active extension
phase.
KARE’s primary efficacy endpoint is the 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 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.
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
StatementsStatements 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 and 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 March 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 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 Starr 6 Degrees
973-415-8838 astarr@6degreespr.com
INVESTOR CONTACT:
Jane UrheimStern Investor Relations,
Inc.jane.urheim@SternIR.com
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