-=Cara Therapeutics (CARA) : disappointing Korsuva data for kidney disease
- Reports mixed topline results from its Phase 2 dose-ranging trial of Oral KORSUVA (CR845/difelikefalin) for the treatment of pruritus in patients with stage III-V (moderate-to-severe) chronic kidney disease; miss on secondary endpoints overshadows primary endpoint
Cara Therapeutics announced positive topline results from its Phase 2 dose-ranging trial of Oral KORSUVA for the treatment of pruritus in patients with stage III-V (moderate-to-severe) chronic kidney disease
Patients treated with the 1 mg tablet strength of Oral KORSUVA achieved the primary endpoint of statistically significant reduction in weekly mean of the daily WI-NRS scores vs. placebo after the 12-week treatment period (-4.4 KORSUVA vs. -3.3 placebo, p=0.018). The treatment effect was statistically significant after two weeks of treatment and sustained through the 12-week treatment period.
The proportion of patients on 1 mg tablet strength achieving a 3 point or greater improvement from baseline in the weekly mean of the daily WI-NRS score at week 12 was 72% vs. 58% for placebo but did not achieve statistical significance.
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