Benzinga | Jan 10, 2022 08:34AM EST

Cara Therapeutics Announces Difelikefalin Injection Topline Results In Phase 3 Clinical Study In Japan

Cara Therapeutics, Inc. (NASDAQ:CARA), an early commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced that its licensing partner Maruishi Pharmaceutical Co., Ltd., and its sublicensee Kissei Pharmaceutical Co., Ltd., confirmed the primary endpoint was achieved in a Japanese Phase 3 clinical study (double-blind, placebo-controlled period) of difelikefalin injection for the treatment of pruritus in hemodialysis patients.



In the Phase 3 study, 178 patients were administered difelikefalin or placebo for 6 weeks followed by an open-label extension period of difelikefalin administration for 52 weeks. The primary endpoint, change in itch Numerical Rating Scale score, and the secondary endpoint, change in itching scores of Shiratori severity criteria, were significantly improved from baseline compared to the placebo group. Difelikefalin was well-tolerated.

"We are pleased that our partner has announced positive topline results from its Phase 3 study in Japan that evaluated difelikefalin for the treatment of pruritus in patients undergoing hemodialysis," said Christopher Posner, President and Chief Executive Officer of Cara Therapeutics. "This marks another significant step forward toward bringing a first-in-class therapeutic to patients suffering from pruritus worldwide."

KORSUVA(tm) (difelikefalin) injection was approved by the U.S. Food and Drug Administration in August 2021 for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. Cara's U.S. commercial partner Vifor Pharma is on track to launch KORSUVA injection in the U.S. early in the second quarter of 2022. In addition, the Marketing Authorization Application for difelikefalin injection for the treatment of pruritus associated with chronic kidney disease in hemodialysis patients is undergoing review with the European Medicines Agency.