The topic is The First-Publishing of KBP-5074 Moderate to Serve Chronic Kidney Disease (CKD) and Hemodialysis Patients Data.
There are about 120 million chronic kidney disease (CKD) patients among which about 18 millions are also uncontrolled hypertension patients in China, and in USA, the numbers are 24 million and 3.5 million. Clinical studies have demonstrated that MRAs have therapeutic effects on CKD, hypertension and heart failure, especially for CKD and CKD patients with Hypertension or Heart Failure. However, currently marketed or under-studied MRAs cause serious side effects of hyperkalemia, which can lead to arrhythmia and cardiac arrest. These MRAs are not suitable for moderate and advanced stage CKD patients with various cardiovascular co-morbidities.
KBP-5074 is a non-steroidal mineralocorticoid receptor antagonist (MRA). 46 healthy volunteers were enrolled in phase 1 clinical trial in USA and the results showed that KBP-5074 has good tolerance and safety, and no effect on serum potassium level was observed even in highest dose. The phase 2a clinical trial was designed to focus on mild to moderate CKD patients with albuminuria who is at high risk of hyperkalemia. The main objective of this clinical trial is to evaluate the safety (including the impact on serum potassium levels) and efficacy (the present change from baseline in Urinary Albumin to Creatinine Ratio (UACR)). To achieve this purpose, the clinical trial was divided into two therapeutic dose cohorts (2.5 mg QD/56 days and 0.5 mg QD/56 days) with 14 patients (10 of them are moderate CKD patients). After 8 weeks’ treatment, the UACR of all tested patients were reduced by 50% to 60%, and there was no hyperkalemia in 0.5 mg QD cohort and 2 out of 7 patients showed transient hyperkalemia in 2.5 mg QD cohort. Besides, KBP-5074 was not detected from the dialysate in another clinical trial in which the hemodialysis patients were dosed 0.5 mg. The result indicates that KBP-5074 can be used for the treatment of hemodialysis patients.
About KBP BioSciences
KBP BioSciences is a clinical stage biotech company dedicated to research and development of internationalized innovative medicines. Based on cutting edge new drug development ideas and its own strength, aimed at meeting unmet medical needs globally, the company devotes its resources in three therapeutic areas, cardiovascular and cerebrovascular diseases, multidrug resistant bacterial infection, and inflammatory& autoimmune disease. KBP has built a proprietary R&D platform aimed at supporting the research and development of global first-in-class compounds.
Headquartered in Jinan, China, KBP’s three clinical stage compounds have all obtained US FDA and CFDA IND approvals and started clinical trials in USA. The management team of KBP’s US affiliate has decades of combined experiences in global clinical development and commercialization. They are in charge of the clinical R&D processes and subsequent marketing operation in USA.
KBP Biosciences Co., Ltd. is looking forward to building cooperation relationships with friends from various areas.
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