Benzinga | Apr 29, 2021 08:15AM EDT

Cara Therapeutics' Stock Plummets As Korsuva Flunks In Mid-Stage Atopic Dermatitis Study

* Cara Therapeutics Inc (NASDAQ: CARA) shares dive after as investors react to topline results from its KARE Phase 2 trial evaluating oral Korsuva (difelikefalin tablets) for the treatment of moderate-to-severe pruritus in mild-to-severe atopic dermatitis (AD) patients.

* The trial's primary efficacy endpoint was the change from baseline in the weekly mean of the daily 24-hour Itch score at week 12 of the treatment period.

* The study failed to meet the primary endpoint in the ITT patient population.

* But a statistically significant improvement from baseline was evident as early as week 1 for the 1 mg dose group, which was sustained through 75% of the treatment period.

* In a prespecified analysis, a statistically significant change in the primary efficacy endpoint was observed in the mild-to-moderate patient population, which was evident at week 1 and sustained through the treatment period.

* Prespecified analysis by disease severity indicated a statistically significant improvement, with 32% of Korsuva-treated patients achieving a ?4 point reduction in itch score at Week 12 versus 19% in the placebo group.

* A statistically significant improvement was also achieved for the 0.5 mg dose.

* Oral KORSUVA was generally well-tolerated across all doses.

* The company will host a conference call today at 8:00 a.m. ET

* Price Action: CARA shares are down 37% at $16.25 in the premarket session on the last check Thursday.