Kidney disease affects more than 850 million people worldwide. According to estimates from the Centers for Disease Control and Prevention, 15% of American adults, or about 37 million people, have chronic kidney disease (CKD). About 95% of people with CKD are in the early stages of the disease. Despite its enormity, early-stage CKD (1–3) still remains underdiagnosed and undertreated, mainly because of its asymptomatic nature at this stage of the disease. It is estimated that up to 9 in 10 adults with CKD and 2 in 5 adults with severe CKD do not know they have the condition. Now, a consortium of industry, academic and clinical research leaders aims to change that by developing a personalized drug response test in CKD.
Renalytics plc (London, UK) announces the launch of Prime-CKD, a consortium of industry, academic and clinical research leaders aiming to validate and implement new biomarker-based tests into clinical practice that enhance the efficacy of existing drugs Let’s guess the reaction of. by patients diagnosed with CKD. PRIME-CKD is funded by Horizon Europe, the EU’s flagship funding program for research and innovation. The project has a total budget of $10 million over an estimated period of five years, with approximately 10% of the budget reserved for commercial translation activities by Renalytix.
The consortium brings together leading experts from 11 academic institutions as well as partners from representative patient foundations and regulatory agencies. The PRIME-CKD consortium will focus on demonstrating the utility of new biomarkers as tools to enable better selection of drug treatment for patients, in daily clinical practice as well as clinical trials. Can also be used in If some biomarkers are successful, the PRIME-CKD program will seek their qualification through the European Medicines Agency and the US FDA for this purpose. The PRIME-CKD program builds on groundbreaking findings from the Innovative Medicines Initiative 2 BEAt-DKD program launched in 2016, which identified new biomarkers of disease progression and treatment response in patients with diabetic kidney disease. The project is expected to benefit from Renalytics’ expertise in biomarker research and translation of existing Urinary Epidermal Growth Factor (UEGF) intellectual property, to which the company has exclusive access.
This project is closely aligned with Renalytics’ goal of expanding the clinical utility of the KidneyIntelX platform beyond forecasting to predict and monitor drug response. KidneyIntelX is a laboratory-developed test that has been shown to be a reliable bioprognostic method that produces an easy-to-understand, personalized risk score to predict whether adults with T2DM and early CKD (stages 1-3) Patients at risk have a low, intermediate, or high degree of rapid and progressive decline in renal function. By combining information from KidneyIntelX with new heart and kidney protective therapies, physicians will have more information to determine which patients are at higher or lower risk of rapid disease progression. Based on the information, clinicians can better target guideline-recommended resources and treatments to promote kidney health. KidneyIntelX has demonstrated a 72% improvement in identifying patients at high risk of rapid and progressive decline in kidney function compared to current standard therapy (eGFR and RACU).
“The results of this project are expected to translate into significant benefits for patients and a reduction in the societal costs associated with CKD by helping to ensure that patients do not develop or prevent kidney failure requiring dialysis or transplantation.” The most effective therapy is received at the right time.” said Hiddo JL Herspink, program coordinator at the University Medical Center Groningen, The Netherlands.
“The opportunity to participate in the PRIME-CKD program, coupled with the continued development of novel biomarkers through our collaboration with the Joslin Diabetes Center and planned data generation in full clinical studies expected in 2023, is poised to serve as a precision medicine platform in CKD. further strengthens KidneyIntelX in the U.S.,” added Fergus Fleming, CTO of Renalytics, who will serve on the Prime-CKD Steering Committee and lead the implementation of research results into clinical practice.
