REG - Renalytix PLC - KidneyIntelX evidence presented at ADA

RenalytixAnnouncement

07/07/2023 07:00

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RNS Number : 2729F  Renalytix PLC  07 July 2023

 

Renalytix plc

("Renalytix" or the "Company")

 

Late-Breaking KidneyIntelX Evidence Released at 83rd American Diabetes
Association Scientific Sessions

12 Months KidneyIntelX™ in vitro prognostic testing continued to demonstrate
clinical actions that lead to improvement in both diabetes (A1C reductions)
and kidney health (eGFR slope improvement) in patients with Type 2 Diabetes
and Chronic Kidney Disease

 

LONDON and SALT LAKE CITY, July 7, 2023 (GLOBE NEWSWIRE) -- Renalytix plc
(NASDAQ: RNLX) (LSE: RENX) today announced late-breaking new clinical data
demonstrating that KidneyIntelX in vitro prognostic use was associated with
post-test actions that led to sustained improvements in both type 2 diabetes
and chronic kidney disease health through 12 months.  The results are from
the evaluation of 2,317 patients being followed in a large real-world evidence
(RWE) study in New York City. The twelve-month outcome data
(https://diabetesjournals.org/diabetes/article/72/Supplement_1/12-LB/150261/12-LB-Clinical-Impact-of-Risk-Profiling-with?searchresult=1)
were presented at the American Diabetes Association (ADA) 83(rd) Scientific
Sessions held June 23-26, 2023, in San Diego, California.

 

There are approximately 14 million adults with diabetic kidney disease in the
U.S. today(1), and that number could more than double by the year 2060(2) due
to rising trends in obesity and diabetes. KidneyIntelX is designed for use in
patients with type 2 diabetes and stages 1-3 of kidney disease (early-stage
diabetic kidney disease, DKD) to assess which patients are at low,
intermediate, or high risk for a rapid progressive decline in their kidney
function.

 

Type 2 Diabetes Improvements Evidenced by Hemoglobin A1c in Higher Risk
Groups:

In patients classified as high risk, median A1C levels improved by 0.7%, a
decrease from 8.2% (pre-test) to 7.5 (post-test) at one year (p< 0.001);
median HbA1c decreased from 7.5% to 7.3% for patients in the intermediate risk
group (p=0.001), and median A1C decreased from 7.1% to 7.0% in the low risk
patients. (p=0.9).

 

These results support that the previously published improvement in A1C levels
observed at six months pre and post KidneyIntelX testing, has been sustained
for the full year, especially in the higher-risk patients.

 

Kidney Disease Improvement or Stability Demonstrated by Median eGFR Slope
Improvement Across all Risk Groups

GFR slope is widely accepted as a clinical measure to determine the
progression of chronic kidney disease (CKD).  In patients classified as high
risk by KidneyIntelX, median eGFR slope improved from -7.1 (pre-test) to
4.5ml/min/1.73m(2  )(post-test) at one year (p=0.01), indicating a slowed
progression of their disease.  For patients with an intermediate risk score,
median eGFR slope was stable at -1.5 (pre vs. post-test) to
-1.4ml/min/1.73m(2) at one year (p=0.6) while patients classified as low risk,
the median eGFR slope improved from -1.9 (pre-test) to -0.28 ml/min/1.73
m(2)/year (p<0.01), further highlighting a need for broad engagement at
both ends of the risk spectrum.

 

This data builds upon the RWE 6-month interim results published in the Journal
of Primary Care and Community Health (November 2022) which demonstrated a
reduction in the amount of urinary (albumin) protein in the low and
intermediate KidneyIntelX risk groups.

 

The authors concluded that the use and deployment of KidneyIntelX to risk
stratify patients with early-stage diabetic kidney disease was associated with
escalation in various actions taken to optimize cardio-metabolic-kidney
health, including guideline-based pharmacy management and specialist
consultation. Furthermore, glycemic control and kidney health improved
post-KidneyIntelX testing, with the largest improvements observed in those
scored as high-risk.

 

Importantly this data demonstrates that implementation of KidneyIntelX in
patient care leads to improved clinician and patient engagement directed to
slowing the progression of diabetic kidney disease and associated
cardiovascular complications.

 

In addition, during the ADA meetings, the Company presented validation data
(https://diabetesjournals.org/diabetes/article/72/Supplement_1/411-P/149700/411-P-Extended-Validation-of-KidneyIntelXTM-in?searchresult=1)
from a new IVD assay developed utilizing the KidneyIntelX platform.  The risk
score calculation was updated to incorporate the new race-free eGFR
calculation, the availability of contemporary patient cohorts reflecting
recent changes in care for diabetic kidney disease, and simplification of test
inputs to enhance clinical adoption in the primary care setting.

 

The updated version of KidneyIntelX utilizes the same three biomarkers, and
three clinical features. It was validated in an external cohort with overall
excellent performance characteristics which included diverse subgroups of the
intended use population.

 

Commenting on the data releases at the American Diabetes Association 83(rd)
Scientific Sessions, Dr. Michael Donovan, Chief Medical Officer at Renalytix
adds, "We are at an important inflection point in the overall understanding
and management of kidney disease progression in the type 2 diabetic patient
population.  Precision based tools such as the KidneyIntelX assay provide a
patient-level biological assessment of (DKD) disease potential for which
population-based algorithms based on standard clinical variables will never be
able to achieve."

 

For further information, please contact:

 

 Renalytix plc                                                  www.renalytix.com (http://www.renalytix.com)
 James McCullough, CEO                                          Via Walbrook PR

 Stifel (Nominated Adviser, Joint Broker)                       Tel: 020 7710 7600
 Alex Price / Nicholas Moore / Nick Harland / Samira Essebiyea

 Investec Bank plc (Joint Broker)                               Tel: 020 7597 4000
 Gary Clarence / Shalin Bhamra

 Walbrook PR Limited                                            Tel: 020 7933 8780 or renalytix@walbrookpr.com
                                                                (http://renalytix@walbrookpr.com)
 Paul McManus / Lianne Applegarth / Alice Woodings              Mob: 07980 541 893 / 07584 391 303 / 07407 804 654

 CapComm Partners
 Peter DeNardo                                                  Tel: 415-389-6400 or investors@renalytix.com (http://investors@renalytix.com)

 

About Chronic 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, more than 38 million people, currently
have chronic kidney disease (CKD). Diabetes is the leading cause of kidney
failure, accounting for 44% of new cases. 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. Every day,
13 patients in the United States die while waiting for a kidney transplant.

 

About Type 2 Diabetes

More than 37 million Americans have diabetes (about 1 in 10), and
approximately 90-95% of them have type 2 diabetes. Type 2 diabetes most often
develops in people over age 45, but more and more children, teens, and young
adults are also developing the disease(2). Type 2 diabetes symptoms often
develop over several years and approximately 23% of adults with Type 2
Diabetes are undiagnosed(3). Type 2 diabetes affects many major organs,
including the heart, blood vessels, nerves, eyes and kidneys. Diabetic Kidney
Disease develops in 30-50% of Type 2 diabetes patients(4).

 

About Renalytix

Renalytix (NASDAQ: RNLX) (LSE: RENX) is an in-vitro diagnostics and laboratory
services company that is the global founder and leader in the new field of
bioprognosis™ for kidney health. The leadership team, with a combined 200+
years of healthcare and in-vitro diagnostic experience, has designed its
KidneyIntelX laboratory developed test to enable risk assessment for rapid
progressive decline in kidney function in adult patients with T2D and early
CKD (stages 1-3). We believe that by understanding how disease will progress,
patients and providers can take action early to improve outcomes and reduce
overall health system costs. For more information, visit www.renalytix.com.

 

About KidneyIntelX™

KidneyIntelX™ is a laboratory developed test demonstrated to be a reliable,
bioprognostic™ methodology that yields a simple-to-understand, custom risk
score, enabling prediction of which adult patients with T2D and early CKD
(stages 1-3) are at low, intermediate or high risk for rapidly progressive
decline in kidney function. By combining information from KidneyIntelX with
newer cardio- and reno-protective therapies, doctors will have more
information in determining which patients are at higher versus lower risk for
rapid disease progression and may be able to more appropriately target
resources and guideline-recommended treatments to advance kidney health.
KidneyIntelX is supported by a growing body of clinical, utility and health
economic studies (including a validation study of two large cohorts) and has
demonstrated a 72% improvement in predicting those patients who are at high
risk for rapid progressive decline in kidney function versus the current
standard of care (eGFR and UACR. To learn more about KidneyIntelX and review
the evidence, visit www.kidneyintelx.com.

Sources

1 https://www.theisn.org/blog/2020/11/27/more-than-850-million-worldwide-have-some-form-of-kidney-disease-help-raise-awareness/
(https://www.theisn.org/blog/2020/11/27/more-than-850-million-worldwide-have-some-form-of-kidney-disease-help-raise-awareness/)

2 https://www.cdc.gov/diabetes/basics/type2.html
(https://www.cdc.gov/diabetes/basics/type2.html)

3 https://www.cdc.gov/diabetes/data/statistics-report/index.html
(https://www.cdc.gov/diabetes/data/statistics-report/index.html)

4 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5297507/
(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5297507/)

 

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 impact KidneyIntelX
can have on patients' care management, the commercial prospects of
KidneyIntelX, including whether and to what extent KidneyIntelX will be
successfully adopted by physicians and distributed and marketed, our
expectations regarding reimbursement decisions and the ability of KidneyIntelX
and other potential tests developed using the KidneyIntelX platform to curtail
costs of chronic and end-stage kidney disease, optimize care delivery, address
systemic inequalities 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 31, 2022, 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.

 

 

 

 

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