CARA - Cara reaches main goal in mid-stage trial for pruritus therapy in nerve disorder

• Commercial-stage biopharma, Cara Therapeutics ( NASDAQ: CARA ) announced on Thursday that the company’s lead product difelikefalin reached the primary endpoint in a Phase 2 trial designed to evaluate it in pruritus in patients with notalgia paresthetica (NP).
• NP is a nerve disorder characterized by long-term pruritus or itching in the upper to middle back with no approved therapies.
• The 8-week study involving nearly 120 patients reached the primary efficacy endpoint of change in the weekly mean of the daily 24-hour Worst Itch-Numeric Rating Scale (WI-NRS) score at Week 8, with statistical significance, the company said.
• According to topline data, the 24-hour WI-NRS change from baseline stood at -4.0 for difelikefalin group vs. -2.4 in the placebo arm (p=0.001).
• Significant improvement was seen as early as Week 1 and sustained through Week 8, Cara ( CARA ) said, adding that the oral therapy was well tolerated with a safety profile consistent with observations seen in prior studies.
• Difelikefalin is commercially available as an FDA approved injection named KORSUVA for pruritus linked to chronic kidney disease in adults undergoing hemodialysis.

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