Positive Phase III Trial of Korsuva in hemodialysis patients with pruritus

29 May 2019

Shares of US biopharma company Cara Therapeutics (Nasdaq: CARA), which were suspended ahead of the announcement, leapt as much as 21% after it released positive top-line data from the KALM-1 pivotal Phase III trial of Korsuva (CR845/difelikefalin) Injection in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP). The stock was still up 16.5% at $20.95 by mid-morning.

Notably, the new data showed that Korsuva Injection achieved a statistically-significant improvement in the primary endpoint with a three-point or greater reduction in mean worst itching score versus placebo (p=0.000019) and a well-tolerated safety profile consistent with earlier Korsuva trials.

At least 40% of people with end-stage renal disease suffer from pruritus. There are no US Food and Drug Administration-approved therapies for dialysis patients with moderate-to-severe pruritus.

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