Renalytix plc
(NASDAQ: RNLX) (LSE: RENX) today
announced the presentation of new clinical data for
KidneyIntelX™ bioprognostic™ 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
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.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 RenalytixRenalytix
(NASDAQ: RNLX) (LSE: RENX) is the global founder and leader in the
new field of bioprognosis™ 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.html2
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 otherwise, except as required by
law.
Media Contacts:United States:Chloe
BeaudoinRenalytix(207) 333-7947cbeaudoin@renalytix.com
Outside of the United States:Walbrook PR Limited
Paul McManus / Lianne Applegarth / Alice Woodings
Tel: 020 7933 8780 or renalytix@walbrookpr.comMob: 07980 541 893
/ 07584 391 303 / 07407 804 654
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