Cara Therapeutics reports completion of enrollment of KALM-1 trial of Korsuva for hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus.

Cara Therapeutics, Inc. announced completion of enrollment in the KALM-1 Phase III trial of Korsuva (CR845/ difelikefalin) Injection in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP) . More than 350 hemodialysis patients with CKD-aP have now been randomized across approximately 60 clinical sites in the United States.

Korsuva Injection Phase III Program Update : KALM-1 Phase III Trial : KALM-1 is a multicenter, randomized, double-blind, placebo-controlled 12-week treatment trial in the U.S. with a 52-week open label extension phase that is designed to evaluate the safety and efficacy of 0.5 mcg/kg Korsuva CR845/difelikefalin injection in 350 hemodialysis patients with moderate-to-severe pruritus. The primary efficacy endpoint is the proportion of patients achieving at least a 3?point improvement from baseline in the weekly mean of the daily 24?hour Worst Itch Numeric Rating Scale (NRS) score at week 12. In a completed Phase II trial, the proportion of patients with an improvement from baseline in the weekly mean Worst Itch NRS score of ?3 points at week 8 was statistically significantly higher in the CR845/difelikefalin 0.5 mcg/kg group compared to the placebo group (64% vs. 29%; p<0.01). secondary endpoints include assessment of itch-related quality of life changes measured using the validated self-assessment 5-d itch and skindex-10 scales as well as the proportion of patients achieving> 4-point improvement from baseline in weekly mean of the daily 24-hour Worst Itch NRS score at week 12.

KALM-2 Phase III Trial: In August 2018, Cara announced the dosing of the first patient in its second Phase III efficacy trial (KALM-2), which is similar in design to the KALM-1 trial and will support regulatory filings for approvals worldwide. This global Phase III trial is designed to enroll hemodialysis patients with moderate-to-severe pruritus in the United States, as well as multiple countries in Europe and Asia Pacific. Based on the current patient enrollment rate and future projections, the Company expects to report top-line data from this trial in the second half of 2019.

Phase III Safety Trial : In 2017, the Company initiated a 52-week Phase III safety trial that is designed to enroll up to 240 hemodialysis patients with CKD-aP. This open-label trial is evaluating the long-term safety of Korsuva (CR845/ difelikefalin) Injection at the dose of 0.5mcg/kg and has enrolled more than 200 patients. Thus far, over 100 patients have completed at least six months of treatment, with approximately 40 percent of these through the one-year treatment period. To date, the safety and tolerability have been consistent with data reported in Phase II trials of Korsuva Injection in hemodialysis patients with CKD-aP. Additionally, based on a recent Independent Data Safety Monitoring Board evaluation, no new safety signals have been observed.