Why Mixed Results From This Chronic Kidney Disease Study Aren’t That Great

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Cara Therapeutics Inc. (NASDAQ: CARA) shares were crushed on Tuesday after the firm announced results from its midstage trial in patients with chronic kidney disease. Specifically, the results come from the Phase 2 trial of Korsuva for the treatment of pruritus in patients with stage III–V (moderate-to-severe) chronic kidney disease.

The primary efficacy endpoint was the change from baseline in the weekly mean of the daily 24-hour Worst Itching Intensity Numeric Rating Scale (WI-NRS) score at Week 12 of the treatment period for any of the three tablet strengths versus the placebo.

Secondary endpoints included change from baseline in itch-related quality of life scores at the end of Week 12, as assessed by the total Skindex-10 and 5-D itch scales, as well as the proportion of patients achieving an improvement from baseline of three points with respect to the weekly mean of the daily 24-hour Worst Itch NRS score at Week 12.

Ultimately, the treatment effect was statistically significant after two weeks of treatment and sustained through the 12-week treatment period, meeting the primary endpoint.

Although, the secondary endpoint did not achieve statistical significance, with only 72% of the treatment group and 58% of the placebo achieving a three-point or greater improvement of the baseline for the WI-NRS score.

According to the Centers for Disease Control and Prevention, about 30 million Americans suffer from chronic kidney disease.

Shares of Cara Therapeutics traded down about 29% to $18.36 Tuesday morning, in a 52-week range of $12.19 to $27.55. The consensus price target is $32.11.


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