Cara Therapeutics Announces Outcome from Dose-Finding Part A of KIND 1 Study Evaluating Oral Difelikefalin for Moderate-to-Severe Pruritus in Patients with Atopic Dermatitis

– Oral difelikefalin as adjunct to topical corticosteroids (TCS) did not demonstrate meaningful clinical benefit compared to TCS alone; As a result, Cara will discontinue its clinical program in pruritus associated with atopic dermatitis –

– Late-stage oral difelikefalin clinical programs for pruritus associated with notalgia paresthetica and advanced chronic kidney disease continue to enroll on track with key data readouts expected in 2H24 –

– Cara expects to end 2023 with approximately $100 million in cash –

STAMFORD, Conn., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced the outcome from the dose-finding Part A of the KIND 1 study evaluating the efficacy and safety of oral difelikefalin as adjunct therapy to topical corticosteroids (TCS) for moderate-to-severe pruritus in adult patients with atopic dermatitis (AD). Oral difelikefalin as adjunct to TCS did not demonstrate a meaningful clinical benefit compared to TCS alone, resulting in the Company’s decision to discontinue its clinical program in pruritus associated with atopic dermatitis.

“We are disappointed with the outcome of this study recognizing that comparing the adjunctive use of oral difelikefalin with TCS to TCS alone represented a high clinical bar based on anticipated real-world commercial use. Importantly, we believe that there is no readthrough to our other late-stage clinical programs for oral difelikefalin as monotherapy without TCS in different indications and patient populations, namely notalgia paresthetica (NP) and advanced chronic kidney disease (CKD),” said Joana Goncalves, MD, Chief Medical Officer of Cara Therapeutics. “On behalf of the Cara team, I would like to thank the patients and investigators who participated in this trial and our team for their unwavering commitment to its execution.”

KIND 1 was a Phase 3, two-part, multicenter, randomized, double-blind, controlled study to evaluate the efficacy and safety of oral difelikefalin as adjunct therapy to TCS for moderate-to-severe pruritus in adults with AD. In Part A, patients (n=287) were randomized to receive oral difelikefalin 0.25 mg tablets twice a day (BID) plus TCS, difelikefalin 0.5 mg tablets BID plus TCS, placebo tablets BID plus TCS or placebo tablets BID plus vehicle. The primary endpoint was the proportion of patients with a ≥4-point improvement at Week 12 from baseline in the worst itch NRS.