Cara Therapeutics Announces No Modifications in Trial Size After Completion of Interim Statistical Assessment For KALM-1 Phase 3 Trial Of KORSUVA™ Injection in Hemodialysis Patients with Pruritus
January 02, 2019 at 12:00 pm
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Cara Therapeutics, Inc. 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 IDMC’s recommendation was based on the results of a prespecified interim conditional power assessment conducted after approximately 50% of the targeted patient number completed the designated 12-week treatment period. The Phase 3 U.S. study is a multicenter, randomized, double-blind, placebo-controlled 12-week treatment trial (with a 52-week open label extension phase) that is designed to evaluate the safety and efficacy of 0.5 mcg/kg 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 itching intensity Numeric Rating Scale (NRS) score at week 12. In a completed Phase 2 trial, the proportion of patients with an improvement from baseline in the weekly mean worst itching intensity 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). The Phase 3 trial’s 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 itching NRS score at week 12.
Cara Therapeutics, Inc. is a development-stage biopharmaceutical company. The Company is focused on treatment paradigm to improve the lives of patients suffering from chronic pruritus. It is developing an oral formulation of difelikefalin, a selective, predominantly peripherally acting, non-scheduled Kappa opioid receptor agonist, for the treatment of chronic neuropathic pruritus associated with Notalgia Paresthetica (NP), a common, underdiagnosed neuropathy affecting the upper back. It is conducting Phase II/III Clinical Program in NP. The program is comprised of two studies - KOURAGE 1 and KOURAGE 2, which are double-blind, placebo-controlled, eight-week studies with patients allowed to roll-over into open-label 52-week extensions. It has developed an IV formulation of difelikefalin, for the treatment of moderate-to-severe pruritus associated with advanced chronic kidney disease in adults undergoing hemodialysis. The IV formulation is out-licensed worldwide.
Cara Therapeutics Announces No Modifications in Trial Size After Completion of Interim Statistical Assessment For KALM-1 Phase 3 Trial Of KORSUVA™ Injection in Hemodialysis Patients with Pruritus