TIDMRENX
RNS Number : 6330C
Renalytix PLC
24 February 2022
KidneyIntelX(TM) Clinical Results Presented at World Congress of
Nephrology Demonstrate Improved Prediction of Kidney Function Over
Standard of Care
Data highlights strength of KidneyIntelX for clinical use in
early-stage diabetic kidney disease patients beyond commonly used
markers UACR and historical eGFR change over time
NEW YORK, NY and SALT LAKE CITY, UT February 24, 2022 -
Renalytix plc (NASDAQ: RNLX) (LSE: RENX) today announced the
presentation of new clinical data for KidneyIntelX(TM)
bioprognostic(TM) testing at the World Congress of Nephrology
Annual Meeting. The results provide robust prognostic information
demonstrating the value of KidneyIntelX to predict the future rate
of decline in kidney function compared with current standard
diagnostics in patients with early-stage chronic kidney disease and
type 2 diabetes (diabetic kidney disease), including estimated
glomerular filtration rate (eGFR), urine albumin-creatinine ratio
(UACR), and eGFR slope.
Advanced risk assessment tools, such as KidneyIntelX, enable
primary care physicians to make optimized treatment decisions
through accurate determination of individual patient risk and
provide the opportunity to change intensity of care management
based on that risk. In the short term, KidneyIntelX can more
efficiently assess the integrated impact of changes in key risk
factors (glucose, blood pressure, and albuminuria) on overall
kidney health, which often do not manifest in kidney function
improvements for several years.
"The key takeaway is that historical measurements commonly used
today to understand kidney disease do not provide a clear picture
of the future, " said Steven Coca, DO, MS, Icahn School of Medicine
at Mount Sinai and Co-Founder, Renalytix. "Without KidneyIntelX, it
is very difficult for physicians, especially busy primary care
physicians, to really understand how quickly a patient's kidney
disease will progress, which can contribute to confusion and
undertreatment."
The data results presented also showed the ability to use
KidneyIntelX in conjunction with clinical features to reinforce the
beneficial effects of new therapeutics in the same population.
"Enabling optimal pharmacy management via KidneyIntelX may
ultimately decrease hospital admissions, emergency room visits,
dialysis and kidney failure risks," said Tom McLain, President,
Renalytix. "Most importantly, KidneyIntelX can help improve the
quality of life for patients by enabling primary care physicians to
mitigate risk at the earliest stages of kidney disease."
KidneyIntelX is the only early-stage, bioprognostic solution for
kidney health, and has received Breakthrough Device Designation
from the U.S. Food and Drug Administration.
2022 World Congress of Nephrology presentations are available
for download at:
https://www.kireports.org/issue/S2468-0249(22)X0004-1
Highlights from the abstracts are as follows:
Abstract WCN22-0561: "Added Value of KidneyIntelX for Predicting
Future Kidney Function Decline Compared with Historical eGFR
Trajectories"
-- Traditional kidney metrics, such as high albuminuria or low
estimated eGFR, or historical rate of eGFR decline, do not
adequately determine "future progression" of kidney disease
-- The independent prognostic value of KidneyIntelX was assessed
for future outcomes above and beyond traditional kidney metrics
-- The KidneyIntelX risk score provided robust prognostic
information for future eGFR trajectories and adverse kidney
outcomes beyond ascertainment of baseline kidney function,
glomerular injury, or historical kidney function trajectories
-- This shows additional utility of KidneyIntelX for clinical
care risk stratification and enrichment for clinical trials beyond
commonly used measures
Abstract WCN22-0564 : "Association of Changes in Modifiable
Factors with Changes in KidneyIntelX Risk Scores in the CANVAS
Participants with Prevalent Diabetic Kidney Disease"
-- Prior analyses from the CANVAS trial cohort have shown that
changes in a patient's KidneyIntelX score over time were
informative of prognosis above and beyond the baseline KidneyIntelX
score
-- The associations between changes in common clinical treatment
targets such as systolic blood pressure (SBP), HbA1c, and UACR with
early improvements in kidney health, as measured by KidneyIntelX,
were not previously explored
-- Longitudinal improvements to target SBP, HbA1c and UACR
resulted in meaningful and robust changes in the KidneyIntelX risk
score, particularly in individuals randomized to canagliflozin, in
this post hoc analysis
-- In sum, these data suggest that KidneyIntelX can be used in
conjunction with clinical features to reinforce the beneficial
effects accrued from the treatments in patients with DKD
For further information, please contact:
Renalytix plc www.renalytix.com
James McCullough, CEO Via Walbrook PR
Stifel (Nominated Adviser, Joint Broker Tel: 020 7710 7600
)
Alex Price / Nicholas Moore
Investec Bank plc (Joint Broker) Tel: 020 7597 4000
Gary Clarence / Daniel Adams
Walbrook PR Limited Tel: 020 7933 8780 or renalytix@walbrookpr.com
Paul McManus / Lianne Applegarth / Mob: 07980 541 893 / 07584 391
Alice Woodings 303 / 07407 804 654
CapComm Partners
Peter DeNardo Tel: 415-389-6400 or investors@renalytix.com
About Kidney Disease
Kidney 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.(1)
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.(2) Every day, 13 patients in the United States die while
waiting for a kidney transplant.(3)
About Renalytix
Renalytix (NASDAQ: RNLX) (LSE: RENX) is the global founder and
leader in the new field of bioprognosis(TM) for kidney health. The
company has engineered a new solution that successfully enables
early-stage chronic kidney disease, progression risk assessment.
The Company's lead product, KidneyIntelX, has been granted
Breakthrough Designation by the U.S. Food and Drug Administration
and is 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.renalytix.com.
About KidneyIntelX
KidneyIntelX, is a first-of-kind solution that enables
early-stage diabetic kidney diseases (DKD) progression risk
assessment by combining diverse data inputs, including validated
blood-based biomarkers, inherited genetics, and personalized
patient data from electronic health record, or EHR, systems, and
employs a proprietary algorithm to generate a unique patient risk
score. This patient risk score enables prediction of progressive
kidney function decline in CKD, allowing physicians and healthcare
systems to optimize the allocation of treatments and clinical
resources to patients at highest risk.
Sources
1. https://www.cdc.gov/kidneydisease/publications-resources/ckd-national-facts.html
2. https://www.nicresearch.com/clinical-research-necessary-nephrology/
3. https://optn.transplant.hrsa.gov/
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 benefits, including
economic savings, of KidneyIntelX, the potential for KidneyIntelX
to receive regulatory approval from the FDA, the commercial
prospects of KidneyIntelX, if approved, including whether
KidneyIntelX will be successfully adopted by physicians and
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 21, 2021,
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
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