Cara Therapeutics Announces Outcome of Part A of KOURAGE-1 Study Evaluating Oral Difelikefalin in Notalgia Paresthetica

Core Insights - Cara Therapeutics announced that oral difelikefalin did not show meaningful clinical benefit compared to placebo in the KOURAGE-1 Part A study, leading to the decision to discontinue the clinical program for notalgia paresthetica (NP) [3][4][8] Company Overview - Cara Therapeutics is a development-stage biopharmaceutical company focused on improving the lives of patients suffering from pruritus, with an IV formulation of difelikefalin approved for treating moderate-to-severe pruritus associated with advanced chronic kidney disease in adults undergoing hemodialysis [2] Clinical Study Details - The KOURAGE-1 Part A study was a multicenter, randomized, double-blind, placebo-controlled trial involving 214 patients, assessing the efficacy of oral difelikefalin at doses of 2 mg, 1 mg, and 0.25 mg twice daily over 8 weeks [1] - The primary endpoint was the proportion of patients achieving a ≥4-point improvement in the weekly mean of the daily 24-hour Itch-Numeric Rating Scale (I-NRS) score at Week 8 [1] Financial Position - As of March 31, 2024, the company reported approximately $70 million in cash, cash equivalents, and marketable securities [9] Future Directions - Following the disappointing results, the company plans to wind down the Phase 2/3 clinical program in NP and explore strategic alternatives to maximize shareholder value [8]