Positive clinical outcome data for KidneyIntelX
("RenalytixAI" or the "Company")
KidneyIntelX Demonstrates Performance and Informs Treatment Decisions
in Multinational CANagliflozin CardioVAScular Assessment Study (CANVAS)
Data from 1,325 CANVAS Participants with Baseline DKD Scored with KidneyIntelX
Presented at
Results presented showed comparable risk-stratification with prior validation studies,2 in which participants identified by KidneyIntelX as high risk (15% of the study population, which was comprised of adults with type 2 diabetes and DKD stages 1-3 from 667 centers in 30 countries) had more than an 8-fold higher rate of disease progression compared with those that scored low risk (42% of the population). In contrast, the application of the guideline-recommended KDIGO (Kidney Disease: Improving Global Outcomes) risk classification tool, based on kidney function and urine albumin concentration, only provided a 2.5-fold gradient for DKD progression among study participants identified as high risk compared with those scored as low risk.
This data, presented at the
Dr.
Access to the CANVAS trial cohort, which compared the SGLT2i inhibitor canagliflozin versus a placebo, and collected blood samples in most participants, supported that baseline risk stratification with KidneyIntelX identified individuals most likely to benefit from canagliflozin vs. placebo. Canagliflozin is FDA approved to reduce the risk for end-stage renal disease, worsening of kidney function, cardiovascular death, and hospitalization for heart failure among adults with type 2 diabetes and DKD. Data presented also showed that there was a 3-fold greater magnitude in the protective effect of canagliflozin on longitudinal eGFR slope (a measure of kidney function and cardiovascular risk) for study participants at high baseline risk who received SGLT2i therapy compared with those who scored as low risk.
The data was shared in a poster presentation titled "Clinical Utility of KidneyIntelX in Patients with Early Stages of Diabetic Kidney Disease in CANVAS Participants." The poster can be found through the KidneyIntelX site and the study abstract is available through Kidney International Reports.
For further information, please contact:
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Via Walbrook PR |
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Stifel (Nominated Adviser, Joint Broker) |
Tel: 020 7710 7600 |
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Investec Bank plc (Joint Broker) |
Tel: 020 7597 4000 |
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Walbrook PR Limited |
Tel: 020 7933 8780 or renalytix@walbrookpr.com |
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Mob: 07980 541 893 / 07584 391 303 |
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About Kidney Disease
Kidney disease is now recognized as a public health epidemic affecting over 850 million people globally. The
About KidneyIntelX
KidneyIntelX, is a first-of-kind, bioprognosticTM platform that employs a proprietary artificial intelligence-enabled algorithm to combine diverse data inputs, including validated blood-based biomarkers, inherited genetics, and personalized patient data from electronic health record, or EHR, systems, to generate a unique patient risk score. This patient risk score enables prediction of progressive kidney function decline in chronic kidney disease, or CKD, allowing physicians and healthcare systems to optimize the allocation of treatments and clinical resources to patients at highest risk.
About RenalytixAI
Sources
1. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes | NEJM
2. https://link.springer.com/article/10.1007/s00125-021-05444-0
3. https://www.cdc.gov/kidneydisease/publications-resources/2019-national-facts.html
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Examples of these forward-looking statements include statements concerning: the potential for KidneyIntelX to receive regulatory approval from the FDA, the commercial prospects of KidneyIntelX, if approved, including whether KidneyIntelX will be successfully distributed and marketed, our expectations regarding reimbursement decisions and the ability of KidneyIntelX to curtail costs of chronic and end-stage kidney disease, optimize care delivery and improve patient outcomes. Words such as "anticipates," "believes," "estimates," "expects," "intends," "plans," "seeks," and similar expressions are intended to identify forward-looking statements. We may not actually achieve the plans and objectives disclosed in the forward-looking statements, and you should not place undue reliance on our forward-looking statements. Any forward-looking statements are based on management's current views and assumptions and involve risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, among others: that KidneyIntelX is based on novel artificial intelligence technologies that are rapidly evolving and potential acceptance, utility and clinical practice remains uncertain; we have only recently commercially launched KidneyIntelX; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises. These and other risks are described more fully in our filings with the
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