Benzinga | Jan 11, 2022 08:26AM EST

Renalytix Highlights Study Results For Co.'s KidneyIntelX Published In 'The American Journal Of Nephrology,' Showed 'KidneyIntelX successfully monitors patient response to SGLT2 therapy in 1,325 CANagliflozin CardioVAScular Assessment...'

Renalytix (NASDAQ:RNLX) (LSE: RENX) announced the publication of positive study results for KidneyIntelX(tm) as a risk monitoring tool to assess impact and response to novel treatments for patients with diabetes and chronic kidney disease (CKD) at increased risk for cardiovascular events. These peer-reviewed findings were published in The American Journal of Nephrology.

"This positive study is further demonstration that KidneyIntelX can be used to provide the most effective care pathway for physicians, so patients get the right treatment, at the right time, early in the disease cycle," said Michael J. Donovan, Chief Medical Officer, Renalytix. "Monitoring response to new medications over time is a core part of precision medicine utility for chronic kidney disease control, which could be enabled by KidneyIntelX to provide improved patient care."

"To deliver effective care and cost savings, population health and primary care need to work together to implement simple, straightforward care pathways that can significantly improve patient outcomes," said Jennifer Houlihan, Vice President of Value Based Care and Population Health for Wake Forest Baptist Health. "The CANVAS study results show that risk assessment and monitoring with KidneyIntelX can help primary care physicians and our care team deliver proactive therapeutic management in early-stage diabetic kidney disease. We know that by treating chronic diseases early, the benefits to the patient, health system and payers will be most significant."

The data supports the value of KidneyIntelX to risk stratify disease, monitor treatment response, and assess changes in risk over time, proving clinical utility not only as a bioprognostic(tm) risk assessment tool, but also as a longitudinal monitoring tool. The study identified samples from patients with baseline diabetic kidney disease (DKD) to assess the association of baseline and changes in KidneyIntelX with subsequent DKD progression. This represents the third published, peer-reviewed clinical validation study and the first multinational study for KidneyIntelX.

The CANVAS (CANagliflozin cardioVascular Assessment Study) multinational clinical trial design provided the framework to demonstrate the role of KidneyIntelX risk stratification and response to the novel therapeutic in 1,325 participants from the trial with concurrent DKD and available baseline plasma samples. KidneyIntelX accurately risk-stratified this large multinational cohort for progression of DKD. Greater numerical differences in the eGFR slope for canagliflozin versus placebo were observed in those with higher baseline KidneyIntelX scores. Canagliflozin treatment reduced KidneyIntelX risk scores over time and changes in the KidneyIntelX score from baseline to one year were correlated with future risk of DKD progression, independent of the baseline risk score and treatment arm. These data also show that repeat testing of KidneyIntelX has prognostic and likely clinical utility, and serves as a known benefit in treating those living with DKD.

KidneyIntelX combines three proprietary biomarkers (sTNFR1, sTNFR2, and KIM-1), and seven clinical variables from a patient's electronic health record with machine learning to generate a patient-specific risk score. In May 2019, KidneyIntelX was granted Breakthrough Device designation by the U.S. Food and Drug Administration, recognizing it as a clinically effective diagnostic tool for kidney disease with no other alternative in the U.S.