Cara Therapeutics Inc. (NASDAQ: CARA) shares jumped on Wednesday after the firm announced a key update in its late-stage chronic kidney disease trial.
The firm announced the completion of an interim statistical analysis of its pivotal Kalm-1 Phase 3 trial of Korsuva (CR845/difelikefalin) injection in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP).
Based on the recommendation of the Independent Data Monitoring Committee (IDMC), the trial will continue as planned with no changes to the original enrollment target of 350 patients. The committee’s recommendation was based on the results of a prespecified interim conditional power assessment conducted after roughly 50% of the targeted patient number completed the designated 12-week treatment period.
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Derek Chalmers, Ph.D., D.Sc., president and CEO of Cara, commented:
CKD-associated pruritus is a significant unmet need in patients undergoing hemodialysis, with no effective therapies approved in the United States or Europe. We are very pleased with the IDMC recommendation that the KALM-1 trial proceed as planned with no modifications, and we look forward to completing the study and reporting top-line data in the first half of this year.
The primary efficacy endpoint is the proportion of patients achieving at least a three‑point improvement from baseline in the weekly mean of the daily 24‑hour worst itching intensity Numeric Rating Scale score at week 12. The secondary endpoints include assessment of itch-related quality of life changes.
Shares of Cara were last seen up about 13% at $14.66, with a consensus analyst price target of $26.89 and a 52-week trading range of $11.46 to $24.30.
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