- 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.
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