“We are very pleased with the positive topline data from our global, pivotal Phase III trial of Korsuva Injection, which reinforce the robust results we reported from our U.S. KALM-1 Phase III trial last year,” said Derek Chalmers, president and chief executive officer of Cara.
Korsuva Injection is now FDA approved to treat itching in kidney disease patients.
Cara Therapeutics and Vifor Fresenius Medical Care Renal Pharma (VFMCRP) announced positive topline data from Cara’s KALM-2 Phase III trial. The study evaluated Korsuva Injection(CR845/difelikafalin) injection in hemodialysis patients with pruritus (severe itching) from moderate-to-severe chronic kidney disease (CKD-aP).
CKD-aP, which is stubborn, severe systemic itching, occurs in at least 40% of kidney dialysis patients. It has also been reported in patients with stage III-V chronic kidney disease (CKD) who are not on dialysis.
“We are very pleased with the positive topline data from our global, pivotal Phase III trial of Korsuva Injection, which reinforce the robust results we reported from our U.S. KALM-1 Phase III trial last year,” said Derek Chalmers, president and chief executive officer of Cara. “With these data in hand, we remain on track to submit our New Drug Application (NDA) for Korsuva Injection in the second half of this year to the U.S. Food and Drug Administration (FDA) and, working with our partner Vifor Fresenius Medical Care Renal Pharma, plan to submit for marketing Authorization Approval (MAA) to the European Medicines Agency (EMA) shortly thereafter.”
Cara licensed worldwide rights outside of the U.S., Japan and South Korea, to VFMCRP in May 2018. VFMCRP specializes in kidney therapies. Cara holds full development and commercialization rights for the drug for the treatment of CKD-aP in the U.S. except in the Fresenius Medical Care North America (FMCNA) dialysis clinic. There, the two organizations will project the drug’s use under a profit-sharing deal based on net FMCNA clinic sales recorded by Cara. Otherwise, Cara will have sole promotion responsibilities of Korsuva Injection in all non-FMC clinics in the U.S. and keep all profits from those sales.
At the time, Vifor paid Cara $50 million up front with another $20 million in common stock. Cara was eligible for up to $740 million in milestone payments in addition to tiered sales royalties.
The KALM-2 trial was a global, multicenter, randomized, double-blind, placebo-controlled, 12-week trial with a 52-week open label extension phase. It evaluated 473 hemodialysis patients with moderate-to-severe pruritus. The primary efficacy endpoint was the percentage of patients achieving at least a three-point improvement from baseline for the weekly mean of the daily 24-hour WI-NRS score at week 12.
“I continue to be very impressed by the robust efficacy of Korsuva Injection for the treatment of pruritus in our patients undergoing hemodialysis,” said Steven Fishbane, chief, division of Kidney Disease and Hypertension, Northwell Health and professor of Medicine at Hofstra/Northwell. “Itching is a real issue for our hemodialysis patients and there are no approved treatments in the U.S. or Europe so I am encouraged by the potential of this drug to address a significant unmet need for our patients.”
This was a pivotal trial. In May 2019, Cara announced positive topline results from KALM-1, a Phase III trial as well. It showed statistically significant separation from placebo after a single week of treatment, with the results holding through 12 weeks.
The FDA granted Korsuva Injection Breakthrough Therapy designation for this indication.
