A Phase 2 clinical trial evaluating Cara Therapeutics’ (NASDAQ:CARA) Korsuva (difelikefalin) (formerly CR845) for the treatment of pruritus (itchy skin) in patients with moderate-to-severe chronic kidney disease (CKD) met the primary endpoint.
Specifically, participants receiving the 1 mg strength of Korsuva experienced a statistically significant reduction in the weekly average of daily WI-NRS scores (scale of itching intensity) from baseline at week 12 compared to placebo (-4.4 vs. -3.3, p=0.018). The treatment effect was statistically valid at week 2 and was sustained through the 12-week period.
A key secondary endpoint, the proportion of patients receiving 1 mg who achieved at least a three-point improvement from baseline in the weekly average daily WI-NRS scores at week 12, was not met (72% vs. 58%).
A Phase 3 trial will launch in 2020.
Shares down 19% premarket on light volume.
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