Cara Therapeutics Completes Full Enrollment in KARE Phase 2 Trial of Oral KORSUVA in Atopic Dermatitis Patients with Moderate-to-Severe Pruritus

- Topline data expected in first half of 2021 -

STAMFORD, Conn., Dec. 02, 2020 (GLOBE NEWSWIRE) -- 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.