Cara Therapeutics Announces Topline Results From KARE Phase 2 Dose-Ranging Trial of Oral KORSUVA in Atopic Dermatitis Patients with Moderate-to-Severe Pruritus

       – Study did not meet Primary Endpoint of worst-itch NRS change from baseline at
       week 12 or Secondary Endpoint of 4-point responder analysis in the ITT patient population

       – Study achieved Primary Endpoint of worst-itch NRS change and Secondary Endpoint of 4-point responder analysis in pre-specified analyses of mild-to-moderate AD patients (64% of ITT patient population) –

– Statistically significant improvement in 4-point responder analysis in
mild-to-moderate (BSA <10%) AD patients with 32% of KORSUVA-treated patients achieving a > 4-point reduction vs. 19% in placebo group (p=0.03) –

– KORSUVA was well tolerated at all dose levels –

– Company to host conference call today at 8:00 a.m. ET –

STAMFORD, Conn., April 29, 2021 (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 topline results from its KARE Phase 2 dose-ranging clinical trial of Oral KORSUVA (difelikefalin tablets) for the treatment of moderate-to-severe pruritus in mild-to-severe atopic dermatitis (AD) patients. The trial enrolled 401 patients at multiple clinical sites across the United States

“We are encouraged to have met the expected Phase 3 registration endpoint of a 4-point responder analysis in the mild-to-moderate AD group,” said Joana Goncalves, M.D., Chief Medical Officer at Cara Therapeutics. “We now have a defined patient group and active dose range for Oral KORUSVA in which to design a registration program that we expect to discuss with the FDA in the coming months .”

“The KARE Phase 2 trial demonstrates the unique anti-itch effects of KORSUVA in atopic dermatitis, a highly inflammatory skin disease,” said Dr. Brian Kim, M.D., MTR, FAAD, Co-Director, Center For The Study of Itch And Sensory Disorders, Washington University School of Medicine. “This is novel and promising for a future in which we can treat the central symptom of AD, especially for patients with mild-to-moderate AD who experience severe itch.”

KARE Phase 2 Trial Design and Results

The KARE Phase 2 trial was a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Oral KORSUVA for moderate-to-severe pruritus in 401 adult subjects with atopic dermatitis. Patients were stratified across treatment groups by disease severity. KARE enrolled 64% of patients characterized as mild-to-moderate (BSA<10%) and 36% falling into the moderate-to-severe category (BSA>10%). 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. A prespecified interim conditional power assessment was conducted after approximately 50% of the originally targeted patient number completed the designated 12-week treatment period. Based on the Independent Data Monitoring Committee’s (IDMC) recommendation, the sample size for the 0.5mg dose and placebo groups was increased by approx. 60% respectively.