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Cara Therapeutics Presents Late-Breaking Results of the KOMFORT Phase 2 Trial of Oral Difelikefalin for Pruritus in Notalgia Paresthetica at the 31st EADV Congress
– Study achieved primary endpoint of Worst Itch-Numeric Rating Scale score change from baseline at Week 8 (p=0.001) – – Significant reduction of itch
About this update from Tvardi Therapeutics, Inc.
[{"type":"text","content":"– Study achieved primary endpoint of Worst Itch-Numeric Rating Scale score change from baseline at Week 8 (p=0.001) – – Significant reduction of itch intensity was evident at Day 1 and effect was maintained through Week 8 – – Significantly greater proportion of patients who received oral difelikefalin vs. placebo achieved a complete response in WI-NRS at Week 8 – STAMFORD, Conn., Sept. 08, 2022 (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 results from the KOMFORT Phase 2 clinical trial of oral difelikefalin for the treatment of moderate-to-severe pruritus in notalgia paresthetica (NP). The data will be presented today by Mark Lebwohl, M.D., the lead investigator and Professor and Dean for Clinical Therapeutics and Chairman Emeritus of the Department of Dermatology at the Icahn School of Medicine at Mount Sinai, during a late-breaking news session at the 31st European Academy of Dermatology and Venereology (EADV) Congress. The presentation includes data from 125 patients with NP and moderate-to-severe pruritus who were randomized to receive oral difelikefalin 2 mg twice daily or placebo over an 8-week treatment period. The primary efficacy endpoint of change from baseline in the weekly mean of the daily 24-hour Worst Itch-Numeric Rating Scale (WI-NRS) score at Week 8 was achieved (-4.0 difelikefalin vs. -2.4 placebo, p=0.001). A statistically significant reduction in itch intensity was observed with oral difelikefalin at Day 1 compared to placebo and the effect was maintained through Week 8. Other endpoints included a ≥4-point improvement in WI-NRS, complete response in WI-NRS and safety assessments. A significantly greater proportion of patients achieved a ≥4-point improvement in WI-NRS score at Week 8 with oral difelikefalin vs. placebo (41% difelikefalin vs. 18% placebo, p=0.007). In addition, oral difelikefalin met the complete response endpoint, defined as a WI-NRS score of 0 or 1 for 70% of the daily non-missing WI-NRS scores for the week. At Week 8, a significantly greater proportion of patients receiving oral difelikefalin vs. placebo achieved a complete response (22% difelikefalin vs. 5% placebo, p","length":2859,"tagName":"div"}]