Outcome from dose-finding part A of KIND 1 study evaluating oral difelikefalin for moderate-to-severe pruritus in patients with atopic dermatitis
Cara Therapeutics, Inc. 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.”