Cara Therapeutics' Difelikefalin Aces Mid-Stage Study In Patients With Itchy Skin Disorder

Cara Therapeutics Inc CARA announced topline results from its Phase 2 proof-of-concept trial (KOMFORT) of difelikefalin for moderate-to-severe pruritus in patients with notalgia paresthetica, a nerve disorder characterized by chronic pruritus (itchy skin) of the upper to middle back.
The primary efficacy endpoint was the change from baseline in the weekly mean of the daily 24-hour itch scale (WI-NRS) score at Week 8. Other endpoints included the ≥4-point responder analysis, itch-related quality of life scores, and safety assessments.
Related: Cara Therapeutics' Difelikefalin Improves Itch, Inflammatory Biomarkers In Skin Disorders.
Patients treated with oral difelikefalin achieved the primary endpoint (-4.0 vs. -2.4 placebo), with significant improvement observed as early as Week 1 and sustained through Week 8.
In addition, a statistically significantly greater proportion of patients treated with oral difelikefalin achieved a ≥4-point improvement in WI-NRS score at Week 8 vs. placebo (41% vs. 18%)
Oral difelikefalin was generally well tolerated with a safety profile consistent with that seen in earlier clinical trials. The most common treatment-emergent adverse events reported were: nausea, headache, dizziness, constipation, and increased urine output.
Price Action: CARA shares are down 1.04% at $9.50 during the market session on the last check Thursday.