Cara Therapeutics Announces Successful End-of-Phase 2 Meeting with FDA for I.V. CR845 in Chronic Kidney Disease-Associated Pruritus
Phase 3 pivotal program in hemodialysis patients expected to commence in Q4 2017
STAMFORD, Conn., Oct. 16, 2017 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting peripheral kappa opioid receptors, today announced the successful completion of its End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (FDA). The Company, in consultation with the FDA, has established the key elements of the Phase 3 program to support a New Drug Application (NDA) for I.V. CR845 for the treatment of moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP) in hemodialysis patients. The FDA previously granted Breakthrough Therapy designation to I.V CR845 for moderate-to-severe CKD-aP, for which there are currently no approved therapies in the United States (U.S.).
"We are very pleased with the productive guidance we have received from the FDA during our recent End-of-Phase 2 meeting," said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. "We expect to initiate our pivotal Phase 3 program of I.V. CR845 for the treatment of CKD-aP in hemodialysis patients in the U.S. by the end of 2017, and will continue working closely with the agency to develop CR845 as a potential new therapeutic option for this highly debilitating aspect of CKD as quickly as possible."
The End-of-Phase 2 discussion was supported by positive top-line results from an eight-week clinical trial of I.V. CR845 in 174 hemodialysis patients with moderate-to-severe pruritus. The trial met both its primary endpoint, with a 68 percent reduction in worst itching scores versus placebo after an eight-week treatment period (p < 0.0019), and its secondary endpoint, with a 100 percent improvement in quality of life domains versus placebo (p < 0.0007). I.V. CR845 was well-tolerated in the trial.
About the Ongoing Safety Trial of I.V. CR845 in Hemodialysis Patients
The 52-week Phase 3 safety study, which was initiated in the second quarter of 2017, is enrolling hemodialysis patients with CKD-associated pruritus (CKD-aP) who previously completed one of the Company's prior studies (CR845-CLIN2101 Part A or CR845-CLIN2005 Part B). This open-label trial is evaluating the long-term safety of I.V. CR845 at the 0.5 mcg/kg dose, which met both primary and secondary efficacy endpoints (reduction of itch and improved quality of life, respectively) in the completed Phase 2 trial in hemodialysis patients with moderate-to-severe CKD-aP, and is the selected dose for the planned Phase 3 pivotal trial.
