Novel Biomarker-Based Tests to Predict Response to Drugs for Treatment of Chronic Kidney Disease

Kidney disease affects over 850 million people globally. According to estimates by the Centers for Disease Control and Prevention estimates, 15% of U.S. adults, or about 37 million people, suffer from chronic kidney disease (CKD). Almost 95% of people with CKD are in the early stages of the disease. Despite its magnitude, early-stage (1-3) CKD still remains underdiagnosed and undertreated, mainly due to its asymptomatic nature at this time in the disease. It is estimated that as many as 9 out of 10 adults with CKD, and about 2 out of 5 adults with severe CKD are unaware that they have the condition. Now, a consortium of industry, academic and clinical research leaders aims to change that by developing personalized drug response tests in CKD.

Renalytix plc (London, UK) has announced the launch of PRIME-CKD, a consortium of industry, academic and clinical research leaders, which aims to validate and implement in clinical practice, novel biomarker-based tests that predict response to existing drugs used by patients diagnosed with CKD. PRIME-CKD is funded by Horizon Europe, the European Union’s key funding program for research and innovation. The project has a total budget of USD 10 million over a projected five-year period with approximately 10% of the budget set aside for commercial translation activities to be undertaken by Renalytix.

The consortium brings together leading experts from 11 academic institutions, along with partners from patient representative foundations and regulatory agencies. The PRIME-CKD consortium will focus on demonstrating the utility of novel biomarkers as tools to enable better selection of drug therapies for patients, for use in daily clinical practice as well as clinical trials. If some of the biomarkers are successful, then the PRIME-CKD program will seek their qualification through the European Medicines Agency and the U.S. FDA for this purpose. The PRIME-CKD program builds on breakthrough findings in the Innovative Medicine Initiative 2 program BEAt-DKD initiated in 2016 that identified novel biomarkers of disease progression and treatment response in patients with diabetic kidney disease. The project is expected to benefit from Renalytix’s expertise in biomarker research translation and existing intellectual property on urinary Epidermal Growth Factor (uEGF) for which the company enjoys exclusive access.

The project is closely aligned with Renalytix’s objective of expanding the clinical utility of the KidneyIntelX platform beyond prognosis to prediction and monitoring of drug response. KidneyIntelX is a laboratory developed test which has shown to be a reliable, bioprognostic methodology that yields a simple-to-understand, custom risk score, enabling prediction of which adult patients with T2D and early CKD (stages 1-3) are at low, intermediate or high risk for a rapid progressive decline in kidney function. By combining information from KidneyIntelX with newer cardio- and reno-protective therapies, physicians will gain access to more information for determining which patients are at higher or lower risk for rapid disease progression. Based on the information, physicians could then target resources and guideline-recommended treatments to advance kidney health in a more appropriate manner. KidneyIntelX has shown a 72% improvement in identifying patients at a high risk for rapid progressive decline in kidney function versus the current standard of care (eGFR and UACR).

“Results from this project are expected to translate into significant patient benefits and decreased societal costs associated with CKD by helping ensure that patients receive the most effective therapy, at the right time, to slow or prevent the kidney failure requiring dialysis or transplant,” said Hiddo J.L Heerspink, the program coordinator from the University Medical Center Groningen, Netherlands.

“The opportunity to participate in the PRIME-CKD program combined with ongoing development of novel biomarkers from our collaboration with Joslin Diabetes Center and planned data generation in completed clinical studies expected in 2023, further strengthens KidneyIntelX as a precision medicine platform in CKD,” added Fergus Fleming, Chief Technology Officer of Renalytix who will serve on the steering committee for PRIME-CKD and lead the implementation of the research outputs into clinical practice.

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