Cara Therapeutics Initiates Pivotal Phase 3 Efficacy Trial of KORSUVA™ (CR845/difelikefalin) Injection in Hemodialysis Patients with Chronic Kidney Disease-Associated Pruritus
January 31, 2018 at 05:30 pm IST
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Cara Therapeutics, Inc. announced the initiation of its first pivotal Phase 3 efficacy trial of KORSUVA™ (CR845/difelikefalin) injection in hemodialysis patients suffering from moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP) in the United States (U.S.). The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to KORSUVA™ injection for this indication, for which there are currently no approved therapies in the U.S. KALM-1 Phase 3 Trial Design: 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) in the U.S. designed to evaluate the safety and efficacy of 0.5 mcg/kg of KORSUVA 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 with respect to 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 eight was statistically significantly higher in the KORSUVA 0.5 mcg/kg group compared to the placebo group (64% vs. 29%; p<0.01). Secondary endpoints of the Phase 3 trial include assessment of itch-related quality of life changes measured using 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. The FDA has conditionally accepted KORSUVA™ as the trade name for difelikefalin injection. CR845/difelikefalin is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.
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 Initiates Pivotal Phase 3 Efficacy Trial of KORSUVA™ (CR845/difelikefalin) Injection in Hemodialysis Patients with Chronic Kidney Disease-Associated Pruritus