Cara Therapeutics and Vifor Fresenius Medical Care Renal Pharma Announce Positive Results From Global KALM-2 Pivotal Phase 3 Trial of KORSUVATM Injection in Hemodialysis Patients with Pruritus

• Statistically significant improvement in primary endpoint of proportion of patients with three point or greater reduction in mean Worst Itching Intensity NRS score vs. placebo (p=0.02) -
  
  
• Statistically significant improvement in key secondary endpoint of proportion of patients with four point or greater reduction in mean worst itching intensity NRS score vs. placebo (p=0.01) -
  
  
• KORSUVA Injection NDA and MAA submission expected in the second half of 2020 -
  
  
• Cara to host conference call today at 8:30 a.m. ET -

STAMFORD, Conn. and ST. GALLEN, Switzerland, April 21, 2020 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq:CARA) and Vifor Fresenius Medical Care Renal Pharma (VFMCRP), today announced positive topline data from Cara’s KALM-2 pivotal Phase 3 trial of KORSUVA (CR845/difelikefalin) Injection in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP).

“We are very pleased with the positive topline data from our global, pivotal Phase 3 trial of KORSUVA Injection, which reinforce the robust results we reported from our U.S. KALM-1 Phase 3 trial last year,” said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. “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.”

“I continue to be very impressed by the robust efficacy of KORSUVA for the treatment of pruritus in our patients undergoing hemodialysis,” said Steven Fishbane, M.D., 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.”

“We are delighted with this outcome and congratulate the Cara team on the positive topline Phase 3 data on KORSUVA Injection in hemodialysis patients with moderate-to-severe pruritus,” said Stefan Schulze, Vifor Pharma President of Executive Committee and Chief Operating Officer. “KORSUVA Injection has the potential to serve as a breakthrough therapeutic for treating this serious itching condition in hemodialysis patients, and is a natural fit to our leading nephrology-focused product portfolio. We are committed to making KORSUVA Injection available as quickly as possible to hemodialysis patients, who urgently need effective therapy.”