CARA - Cara Therapeutics plunges after the setback in mid-stage atopic dermatitis trial

Cara Therapeutics (CARA) has lost ~36.8% in the pre-market after the company announced that its Oral KORSUVA (difelikefalin tablets) failed to meet the primary endpoint in Phase 2 dose-ranging clinical trial in atopic dermatitis patients with moderate-to-severe pruritus.The randomized, double-blind, placebo-controlled study involved 401 adult subjects with atopic dermatitis., who were randomized to three tablet strengths of Oral KORSUVA: 0.25 mg, 0.5 mg, and 1 mg against placebo.Following a recommendation from Independent Data Monitoring Committee (“IDMC”), the company has reduced the sample size for the 0.5mg dose and the placebo groups by ~60%, respectively.No dose group has reached the primary efficacy endpoint: the change from baseline in the weekly mean of the daily 24-hour Itch NRS score at week 12 of the treatment period.The key secondary endpoint was the percentage of patients who achieved an improvement from a baseline of ?4 points in the weekly mean of the daily 24-hour Itch NRS

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Cara Therapeutics plunges after the setback in mid-stage atopic dermatitis trial