back

January 7, 2022

Positive Topline Results from Japanese Phase III Clinical Study (double-blind period) of Difelikefalin (MR13A9) in Hemodialysis Patients with Pruritus

Kissei Pharmaceutical Co., Ltd. (Head Office: Matsumoto, Nagano, Japan; Chairman and CEO: Mutsuo Kanzawa; "Kissei") and Maruishi Pharmaceutical Co., Ltd. (Head Office: Tsurumi, Osaka, Representative Director and President: Katsuhito Inoue; "Maruishi") today announced that the primary endpoint was achieved in a Japanese Phase III Clinical Study (double-blind period) of Difelikefalin (generic name, Product Code: MR13A9) for the treatment of pruritus in dialysis patients.

Difelikefalin is a kappa opioid receptor agonist originated and developed by Cara Therapeutics, Inc. (Head Office: USA, President and CEO: Christopher Posner: "Cara"), and is the first intravenous formulation product in the world for the treatment of pruritus in dialysis patients. It was approved by the US Food and Drug Administration in August 2021 for the treatment of moderate to severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis, and is under review for MAA in Europe.

This phase III study was conducted in 178 patients with pruritus in hemodialysis patients. During double-blind period, patients are administered with difelikefalin or placebo for 6 weeks followed by open-label extension period of difelikefalin administration for 52 weeks. Double-blind period was finished this time, and the primary endpoint, which is "Change in itch Numerical Rating Scale (NRS) score" and the secondary endpoint, which is "Change in itching scores of Shiratori severity criteria" were significantly improved from baseline compared to placebo group. Difelikefalin demonstrated a safe and well-tolerated profile.

Kissei and Maruishi strive to expand treatment options for uremic pruritus to contribute to improving QOL (Quality of Life) of patients on dialysis.




《 Reference 》

About uremic pruritus in dialysis patients
Uremic pruritus is a common itching condition in the absence of obvious skin lesion that occurs with the patient of end-stage renal disease undergoing hemodialysis.
Long-lasting and intense distressing itching in these patients is related to low QOL with poor sleep quality, depression, and an increased risk of death.

About Difelikefalin (generic name, Product Code: MR13A9)
Difelikefalin is a new compound originated and developed by Cara Therapeutics, Inc. and is a selective kappa opioid receptor (KOR) agonist. It is considered that endogenous opioids are related to pruritus as one of the expression mechanisms of pruritus in dialysis patients. Difelikefalin selectively activates KOR which is one of the subtypes of opioid receptors, and is expected to suppress pruritus.

About NRS (Numerical Rating Scale) score for itch
The NRS score for itch is a score that evaluates with an integer from 0 to 10 where "no itch" is 0 and "the worst itch" is 10 for the most intensely itching felt in the day.

About Shiratori severity criteria score
Shiratori severity criteria score is a score that evaluates once a day with an integer from 0 to 4 where "no symptoms" is score of 0 and "severe itching" is 4 for each degree of itching during the day and night.

About Kissei Pharmaceutical Co., Ltd.
Kissei is a Japanese pharmaceutical company based on the management philosophy "contributing to society through high-quality, innovative pharmaceutical products" and "serving society through our employees." As a strong R&D-oriented corporation, it concentrates on providing innovative pharmaceuticals to patients worldwide in the focus fields of urology, nephrology/dialysis, gynecology and rare/intractable diseases.
For more details about Kissei Pharmaceutical Co., Ltd., please visit https://www.kissei.co.jp/

About Maruishi Pharmaceutical Co., Ltd.
Maruishi is a specialty pharma that has a strong presence in the perioperative and infection control area, and is known as a leading producer of Japanese Pharmacopoeia drugs. Making use of the technology, knowledge, and know-how that have been cultivated over 130 years of history, Maruishi continues to contribute to the healthcare and improvement of QOL of the patients.
For more details about Maruishi Pharmaceutical Co., Ltd., please visit https://www.maruishi-pharm.co.jp/

About Cara Therapeutics, Inc.
Cara Therapeutics is an early commercial-stage biopharmaceutical company leading a new treatment to improve the lives of patients suffering from pruritus. The company's novel KORSUVA™ (difelikefalin) injection is the first and only FDA-approved treatment for moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis.
For more information, visit https://www.caratherapeutics.com and follow the company on Twitter, LinkedIn and Instagram.