Cara Therapeutics Inc. (NASDAQ: CARA) shares jumped on Wednesday after the firm announced topline data from its late-stage trial in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP). Specifically, this is a Phase 3 study of Korsuva.
Some quick background: CKD-aP is an intractable systemic itch condition that occurs with high frequency and intensity in patients undergoing hemodialysis and peritoneal dialysis. Multiple studies estimate that at least 40% of patients with end-stage renal disease suffer from pruritus.
The study achieved its primary endpoint of patients achieving a three-point or greater improvement from baseline in the weekly mean of the daily 24-hour Worst Itching Intensity Numeric Rating Scale (WI-NRS) score. At week 12, it was 51%, versus 28% for patients on placebo.
The secondary endpoint saw 39% of patients achieving a four-point or greater improvement from baseline in the weekly mean of the daily 24-hour WI-NRS score at week 12, versus 18% for patients on the placebo.
Note that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Korsuva Injection for this indication.
Derek Chalmers, Ph.D., D.Sc., president and CEO of Cara, commented:
We are extremely pleased with the robust topline results from our first pivotal Phase 3 trial of KORSUVA Injection and are particularly encouraged by the early anti-pruritic response with KORSUVA Injection, which resulted in statistically significant separation from placebo after only one week of treatment and a sustained significant benefit through 12 weeks,” “We look forward to reporting topline data from our second global Phase 3 trial, KALM-2, in the second half of this year and, assuming positive results, moving towards an NDA submission as quickly as possible thereafter.
Shares of Cara Therapeutics were up 18% at $21.23 Wednesday morning, in a 52-week range of $12.19 to $24.30. The consensus price target is $26.20.
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