Full Press Release Details
Cara Therapeutics Announces Completion
of Interim Statistical Assessment for KARE Phase 2 Trial of Oral KORSUVA in Atopic Dermatitis Patients with
Moderate-to-Severe Pruritus
STAMFORD, Conn., June 17, 2020 -
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 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 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
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