KidneyIntelX Demonstrates Performance and Informs Treatment Decisions in Multinational CANagliflozin CardioVAScular Assessmen...
April 20 2021 - 6:00AM
Renalytix AI plc (LSE: RENX) (NASDAQ: RNLX) announces the findings
of a new study in which the commercially available KidneyIntelX
test accurately predicted progression of diabetic kidney disease
(DKD) in a multinational cohort from the CANagliflozin
CardioVAScular Assessment Study (CANVAS)1 with early-stage DKD
(stages 1-3). The clinical outcome data suggests that KidneyIntelX
risk assessment could support primary care physicians in making
appropriate therapeutic intervention decisions with early-stage DKD
patients to effectively delay progression and reduce the risk of
adverse events.
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 International Society of Nephrology
World Congress of Nephrology 2021 (WCN ’21), is the first of a
series of outcomes from the analysis of the CANVAS cohort in
conjunction with Janssen Research and Development including the
role of KidneyIntelX in treatment decisions and monitoring
therapeutic effect.
“KidneyIntelX performed very well in a multinational cohort of
individuals with type 2 diabetes and early-stage DKD,” said Dr.
David W. Lam, MD, Medical Director Mount Sinai Clinical Diabetes
Institute and first author on the presentation. “The new data from
CANVAS supports primary care physicians using the KidneyIntelX
score to risk stratify and make informed care decisions with their
patients. The results also advance the concept that there is most
to be gained from early-stage intervention and the protective
effects of SGLT2i on kidney function decline in those that score as
highest risk for progression with KidneyIntelX.”
Access to the CANVAS trial cohort, which compared the SGLT2i
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.
About Kidney DiseaseKidney disease is now
recognized as a public health epidemic affecting over 850 million
people globally. The Centers for Disease Control and Prevention
(CDC) estimates that 15% of US adults, or 37 million people,
currently have chronic kidney disease (CKD). Further, the CDC
reports that 9 out of 10 adults with CKD do not know they have it
and one out of two people with very low kidney function who are not
on dialysis do not know they have CKD.3 Kidney disease is referred
to as a "silent killer" because it often has no symptoms and can go
undetected until a very advanced stage. Each year kidney disease
kills more people than breast and prostate cancer. Every day, 13
patients in the United States die while waiting for a kidney
transplant.
About KidneyIntelXKidneyIntelX, is a
first-of-kind, bioprognostic™ 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 RenalytixAIRenalytixAI (LSE: RENX)
(NASDAQ: RNLX) is a developer of artificial intelligence-enabled
clinical in vitro diagnostic solutions for kidney disease, one of
the most common and costly chronic medical conditions globally. The
Company’s lead product is KidneyIntelX, which has been granted
Breakthrough Designation by the U.S. Food and Drug Administration
and which is being designed to help make significant improvements
in kidney disease prognosis, transplant management, clinical care,
patient stratification for drug clinical trials, and drug target
discovery (visit www.kidneyintelx.com). For more information,
visit www.renalytixai.com
Sources1. Canagliflozin and Cardiovascular and
Renal Events in Type 2 Diabetes | NEJM2.
https://link.springer.com/article/10.1007/s00125-021-05444-03.
https://www.cdc.gov/kidneydisease/publications-resources/2019-national-facts.html
Forward-Looking StatementsStatements 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 Securities and Exchange
Commission (SEC), including the “Risk Factors” section of our
annual report on Form 20-F filed with the SEC on October 28, 2020,
and other filings we make with the SEC from time to time. All
information in this press release is as of the date of the release,
and we undertake no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events, or otherwise, except as required by law.
Media Contacts:United States:Jennifer
MoritzZer0 to 5ive for RenalytixAI(917)
748-4006jmoritz@0to5.com
Outside of the United States:Walbrook PR LimitedPaul McManus /
Lianne CawthorneTel: 020 7933 8780 or renalytix@walbrookpr.comMob:
07980 541 893 / 07584 391 303
Renalytix (NASDAQ:RNLX)
Historical Stock Chart
From Apr 2024 to May 2024
Renalytix (NASDAQ:RNLX)
Historical Stock Chart
From May 2023 to May 2024