Cara Therapeutics Inc. (NASDAQ: CARA) has announced that Maruishi Pharmaceuticals Co. Ltd., its licensing partner, and its sublicensee Kissei Pharmaceuticals Co. Ltd have revealed that the primary objective was attained in a Japanese third phase clinical study of difelikefalin injection for pruritus treatment in patients undergoing hemodialysis. The company is committed to creating new treatments that can improve patient lives of those suffering from pruritus. 

Difelikafalin showed improvement in primary and secondary endpoints. 

In the third phase trial, the researcher gave difelikefalin or placebo to 178 patients for six weeks, preceded by a 52-week open-label difelikefalin extension treatment. Compared to the placebo, patients that received difelikefalin showed significant improvement from baseline with both primary objective in itch Numerical Rating Scale score with a secondary endpoint of change in itching score of Shiratori severity criteria also improving. Also, difelikefalin demonstrated a good tolerability profile in patients. 

President and Chief Executive Officer of Cara Therapeutics, Christopher Posner, said, “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. This marks another significant step forward toward bringing a first-in-class therapeutic to patients suffering from pruritus worldwide.” 

Difelikefalin (KORSUVA) injection received US FDA approval in August last year for moderate to severe pruritus treatment related to chronic kidney disease in individuals undergoing hemodialysis. The company’s commercial partner in the US, Vifor Pharma, plans to commercialize KORSUVA in the US beginning Q2 2022. Additionally, the European Medicines Agency is reviewing the difelikafalin Marketing Authorization Application for pruritus related to chronic kidney disease in patients undergoing hemodialysis. 

Cara is developing oral KORSUVA

Cara Therapeutics is developing an ingestible KORSUVA (difelikefalin) formula for pruritus treatment in patients with non-dialysis-dependent chronic kidney disease and atopic dermatitis and aims to start Phase 3 trials in Q1 2022. Also, oral KORSUVA is currently being tested in individuals with moderate-to-severe pruritus who have primary biliary cholangitis or nostalgia paresthetica.

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