WinHealth Pharma's licensed Difelikefalin injection significantly improves pruritus associated with chronic kidney disease in hemodialysis patients in Phase III clinical study in China
On September 3, 2024, WinHealth Pharma announced the latest research data from the KOR-CHINA-301 study, which aimed to evaluate the efficacy and safety of Difelikefalin injection in pruritus associated with chronic kidney disease in hemodialysis patients. The results of this Phase III confirmatory clinical study in China met the primary endpoint, showing significant superiority over the placebo (P=0.0003). Difelikefalin was well tolerated and showed a safety profile generally consistent with its known safety profile.
Difelikefalin has been approved in the United States, the European Union, and other countries. If it is approved in China, it will offer a safe and effective treatment option with a convenient mode of administration for hemodialysis patients who suffer from itching.
The key findings of the study are as follows:
Primary endpoint：Change from baseline in the Weekly Mean of the Daily 24-hour worst itching intensity numerical rating scale (WI-NRS) Score at Week 4 of the double-blind period was significantly greater in subjects treated with difelikefalin compared to placebo (Difelikefalin minus placebo, LS mean difference (SE) -0.81(0.223), 95%CI (-1.25, -0.37), P=0.0003).
Secondary endpoint: Difelikefalin takes effect rapidly, the difference between difelikefalin and placebo in reducing WI-NRS was significant starting from Week 2 (P＜0.05).
Safety: The safety profile of Difelikefalin in Chinese hemodialysis patients with moderate-to-severe pruritus was acceptable and generally consistent with the known safety profile of the product.
Vifor Fresenius Medical Care Renal Pharma is the sponsor of the trial, Winhealth Pharma is the co-development partner in China, and Tigermed is the CRO. With the joint efforts of the three parties and various research centers, the double-blind phase of the study has been completed. The results of this study will serve as an important reference for the approval and marketing of Difelikefalin in China. It is hoped that the drug will be approved and marketed as soon as possible after the relevant approvals are granted. Winhealth Pharma will provide new treatment options for Chinese hemodialysis patients with moderate-to-severe pruritus, better meeting the clinical treatment needs of patients.
Regarding Difelikefalin
As of February 22, 2024, Difelikefalin, which is globally marketed as KORSUVA®/KAPRUVIA® injection has been approved in 41 countries, including the United States, the European Union (incl. Iceland, Norway, and Liechtenstein), the United Kingdom, Canada, Switzerland, Singapore, Australia, and Japan, for the treatment of adult hemodialysis patients with chronic kidney disease (CKD)-associated pruritus. It is the first peptidic kappa opioid receptor (KOR) agonist therapy to be approved for this indication in China.
Difelikefalin is a KOR agonist that inhibits the sensation of itching by binding to receptors [1]. The hydrophilic peptide structure of Difelikefalin limits its penetration into the central nervous system (CNS), distinguishing it from centrally active KOR agonists. Compared to most opioids, Difelikefalin is not a controlled substance and does not cause adverse effects such as respiratory depression [2-4]. This injection intravenous administration via the dialysis circuit after routine hemodialysis effectively addresses long-term compliance issue caused by the high pill burden in hemodialysis patients.
Winhealth Pharma and Vifor Fresenius Medical Care Renal Pharma signed a long-term exclusive license agreement for the development and commercialization of Difelikefalin injection on January 16, 2023, for the treatment of moderate to severe pruritus in adult hemodialysis patients in China. Winhealth Pharma holds exclusive rights for the development and commercialization of Difelikefalin injection in China.
Regarding chronic kidney disease associated pruritus
Chronic kidney disease-associated pruritus manifests as generalized and persistent itching, which has a significant negative impact on patients' quality of life and can lead to depression, anxiety, sleep disorders, and increased mortality rates. In China, approximately 42%, 21%, 11%, and 8% of hemodialysis patients are suffering from mild, moderate, severe, or very severe pruritus, respectively [5]. Other studies have also reported pruritus prevalence rates in dialysis patients ranging from 36% to 80% [6,7].
Current treatment options vary, including the use of topical treatments (emollients, topical corticosteroids, local anesthetics) for patients with mild or localized symptoms, and optimization of dialysis parameters and systemic therapy for more severe or generalized pruritus [8]. However, existing treatments (topical or systemic) do not fully meet clinical needs, and many patients continue to be troubled by pruritus.
Regarding Winhealth Pharma
WinHealth Pharma is a China-based integrated pharmaceutical company with a core focus on kidney diseases and strategic expansion into hematology and other major therapeutic areas. It possesses comprehensive capabilities across the entire pharmaceutical value chain from research and development to manufacturing and commercialization. Guided by its “Patients-First” philosophy and the mission of “Advancing Health, Empowering Lives,” the company is dedicated to improving patients' quality of life through innovative therapies. By leveraging a multi-strategy-driven business model, WinHealth Pharma connects with global innovations to continuously build a diverse, differentiated, and highly competitive product portfolio. Anchoring a strong presence in China, the company is actively expanding into other Asian markets and key international regions, including Switzerland and Japan. WinHealth Pharma is committed to fostering an open and collaborative healthcare ecosystem, driving industry innovation to meet the evolving needs of patients worldwide. For more information, please visit www.winhealth.hk.
Reference:
1.https://www.ema.europa.eu/en/medicines/human/EPAR/kapruvia
2.https://ir.caratherapeutics.com/static-files/62d3f790-49dc-4882-952b-023e92329efd
Presented at the 8th World Congress on Itch; September 27-29, 2015; Nara, Japan
3.https://ir.caratherapeutics.com/static-files/a713f5b9-f084-4982-bcac-fd2d47490013
4.New England Journal of Medicine 2020; 382:222-232
5. Rayner HC, Larkina M, Wang M, Graham-Brown M, van der Veer SN, Ecder T, et al. International comparisons of prevalence, awareness, and treatment of pruritus in people on hemodialysis. Clin J Am Soc Nephrol. 2017 Dec; 12:2000-7.
6. Li J, Guo Q, Lin J, Yi C, Yang C, Yang X, Yu X. Prevalence and associated factors of uraemic pruritus in continuous ambulatory peritoneal dialysis patients. Intern Med. 2015 Mar 1; 54:2827-33.
7. Wen Y, Liu C, Lin Z, Zhang Z, Sun W, Qin X, et al. Uremic pruritus in Chinese chronic haemodialysis population: a single-centre series study. Acta Medica Mediterranea. 2020; 36:1569.
8. Weisshaar E, Szepietowski JC, Dalgard F, Garcovich S, Gieler U, Giménez -Arnau A, et al. European S2k guideline on chronic pruritus. Acta Derm Venereol. 2019; 99:469- 506.