REG - Renalytix PLC - Positive Data Release at NKF Conference

RenalytixAnnouncement

12/04/2023 07:00

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RNS Number : 8895V  Renalytix PLC  12 April 2023

Renalytix plc

("Renalytix" or the "Company")

 

Data Supportive of KidneyIntelX Utility in Minorities and Veterans to Be
Presented at the National Kidney Foundation Spring Clinical Meeting

 

In a clinical decision effectiveness study, KidneyIntelX classified more Black
vs non-Black patients as high risk for progression of chronic kidney disease,
resulting in  increased prescription of SGLT2-inhibitor

drug therapy

 

Additional study results illustrate how KidneyIntelX is aligned with the
Veteran's Health Administration care practice guidelines for risk assessment
in early-stage kidney disease and the introduction of novel therapies and
timely referral to clinical specialists

 

LONDON and SALT LAKE CITY, April 12, 2023 (GLOBE NEWSWIRE) -- Renalytix plc
(NASDAQ: RNLX) (LSE: RENX) today announced that two scientific presentations
have been accepted at the upcoming National Kidney Foundation Spring Clinicals
Conference taking place in Austin, Texas (April 11-15). The studies entitled
the "Impact of KidneyIntelX testing on novel medication prescription in a
diverse patient population" and "Diabetic kidney disease epidemiology in US
veterans" show the importance of using KidneyIntelX bioprognosis in early
stage kidney disease and diabetes patients to blunt the effects of health
inequity, help guide proper drug prescription to patients in need, and support
established clinical guidelines to slow or stop unnecessary progression to
late stage kidney disease, kidney failure and dialysis.

 

During National Kidney Month in March, Renalytix participated at a national
and global level by hosting several events including a national webinar
entitled, "Diabetic Kidney Disease: Importance of Early Risk Assessment for
Optimal Outcomes" with Dr. Joseph Vassalotti, Clinical Professor of Medicine,
in the Division of Nephrology, at Icahn School of Medicine at Mount Sinai and
Chief Medical Officer for the National Kidney Foundation. The webinar is now
on-demand and available on www.kidneyintelx.com (http://www.kidneyintelx.com)
or via this link
(https://attendee.gotowebinar.com/register/6313643586978796376) .

 

National Kidney Foundation Clinical Spring Conference Data Presentations
Include:

 

Impact of KidneyIntelX testing on novel medication prescription in a diverse
patient population

KidneyIntelX was recently introduced into the Wake Forest-Atrium Health System
to predict progressive decline in kidney function. In 590 patients with (type
2 diabetes) T2D and early stage CKD, despite similar eGFR, UACR and HbA1c in
the Black vs. non-Black populations, the proportion of Black patients in the
high-risk category was 3x higher than non-Black (15 vs. 5%). Identifying the
highest risk patients gives the potential to prescribe novel medications, such
as SGLT2-inhibitors to help stop or slow the progression of disease. The
KidneyIntelX risk score identified those patients at highest risk which
resulted in appropriately selecting SGLT2-inhibitors for the right patients.
Due to the KidneyIntelX score, SGLT2-inhibitors usage markedly increased in
Blacks who were scored as high risk (8.3% pre-test to 25% usage post-test) and
increased from 19% to 32% in those scored as intermediate risk. These data
demonstrate that health care providers can use KidneyIntelX for risk
stratification to guide treatment plans and can be implemented in population
health initiatives toward prevention of complications and improved healthcare
equity.

The data will be showcased from April 12-14 in the Poster Hall at the Austin
Convention Center and the e-poster
(https://casehippo.com/spa/courses/resource/2023-spring-clinical-meetings/event/home/posters/abstracts?abstractId=2531)
is now online at the NKF website.

 

Diabetic kidney disease epidemiology in US veterans

Diabetes is the leading cause of chronic kidney disease, which is a major
burden on the US Veterans Health Administration (VHA) at a cost of
approximately $18 billion in 2014 and an area of clinical focus at the VHA.
Identifying veterans at highest risk is essential to define gaps in DKD
management. In a patient cohort of more than 685,000 veterans with T2D and
CKD, the authors identified a gap in current standard of care in which
patients with early stage DKD (stages 1 and 2) may be left underdiagnosed or
undetected, since the majority of patients (79%) were first identified with
CKD at Stage 3a or 3b. More than one out of ten patients at earlier DKD stages
(G1A2 - G3b) progressed to the next or higher stage within a year, and more
than half of patients at earlier DKD stages progressed to advanced stages or
died within five years. These findings demonstrate that T2D and CKD in veteran
populations may progress rapidly due to a higher prevalence of comorbidities
in the veteran population. In accordance with the goals of VHA Directive 1053,
early recognition and management of CKD allows clinicians more opportunities
to protect kidney health and reduce the risk of kidney failure.

 

This study demonstrates that the Renalytix KidneyIntelX solution as a risk
assessment tool for early-stage CKD is well aligned with established Veteran's
Health Administration care guidelines and the 2020 Directive 1053 recommending
a validated risk prediction model to support clinical decision making in the
management of patients with CKD.

 

The data will be showcased from April 12-14 in the Poster Hall at the Austin
Convention Center and the abstract
(https://casehippo.com/spa/courses/resource/2023-spring-clinical-meetings/event/home/posters/abstracts?abstractId=2245)
is now online at the NKF website.

 

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
                                  (mailto:renalytix@walbrookpr.com)
 Paul McManus / Lianne Applegarth                                  Mob: 07980 541 893 / 07584 391 303

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

 

 

 

 

 

About Kidney Disease

Kidney disease is a public health epidemic affecting over 850 million people
globally.(1) The Centers for Disease Control and Prevention estimates that
15% of U.S. adults, or over 37 million people(2), have chronic kidney disease
(CKD). Nearly 95% of people with CKD are in early stages 1-3(3). Despite its
magnitude, early-stage (1-3) CKD is underdiagnosed and undertreated, largely
because it's asymptomatic at this time in the disease. As many as 9 in 10
adults with CKD, and 2 in 5 adults with severe CKD do not know they have the
condition.(3)

 

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
(http://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 rapid 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 a
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). KidneyIntelX has received Breakthrough
Device Designation from the U.S. Food and Drug Administration and Renalytix
has submitted for De Novo marketing authorization. To learn more about
KidneyIntelX and review the evidence, visit www.kidneyintelx.com
(https://www.globenewswire.com/Tracker?data=pnMyL7OiWYuisE2257B76Ame4kcbRTTwSbTT7hL6KmEb4cmWkDDYS85FbnfQlMYKb4dRb2eSDhDgrPVQpups2l3o0K_VzUlT8MnyxWXleEeiHkzoG91Sc5bZ2ARTF7tUIQSrXnMxyPTg_64IzqTmtJPNemx-5z1GgSIs03VaG5-bo_aJ5c5tRALH2_vsZWhUvWWv0TLZF35WVG3fwXZTmayxYzehdOcQuq0wNUhp8VRZptrY1f8TSw4mNzJhmvrWAjcfbH3_l2oXUJTAwwVieg==)
.

 

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.globenewswire.com/Tracker?data=xcCaiDh3GGa380JtGgU6aPw-xQKtjV8wzL24xpir2iWQXgKCdyO5gWumCXeHVS1cDZcS9TtUre-eMntvqDRG6d7e2Qpi1i38krpFEgVHwJiBbm9Nt4awk8WNrf1Kh5bInbFPl6JK0R79RfNUtIzmEwtHG-PLyu--nDvHEGsR-ML5XixC2Lkeg4DvFmnrx5V7yanHPHvR6UzTC0e88IzcLr-GiF-aqKI3NVLntwB8gd_g1FbijT5B5GWNtTTax44mqTRgbp7lBPdaaRnCTg9QieWylEKIk-i3bpPzeUAJQHRHycyfrqBrJ4JJkkTFv2LHB6iFNMHH-_VNdQpiOVniSgMV5TXy9athTCyNZvzNpEYp5NsSK-5BQ7dpQF82z-oC)

2 https://www.cdc.gov/kidneydisease/publications-resources/ckd-national-facts.html
(https://www.globenewswire.com/Tracker?data=xcCaiDh3GGa380JtGgU6aEEeEtgftvKT10sr_Vj9QNpr6-nMZCXy1PE9coV-Y8Op79svle0yOEjRACVl900EGd6_FwhZz71HtvxI_4NDo5WsoMLQCQwZ8seduXib9ZBPL3zRDUzkowMp8ydDmmztzu_anbNfNwvcHRWNb_59dxGn10g911_YPwyzi476Zz6GdSQHjUN0th1CmTthT9sTpVIrrBtYSo1boseMESZ5Kd8C3oYs-gDxtzCml6v6fC1B)

3 https://www.cdc.gov/kidneydisease/basics.html
(https://www.globenewswire.com/Tracker?data=xcCaiDh3GGa380JtGgU6aEEeEtgftvKT10sr_Vj9QNpfbc5OcH3tT_KAsSe9EOfrCmR-M8vBLxcvlUzNsUZTzTvWGKkYK9dtbQtgujeXxYaG0mjg1OKJ0RV6GsVSWBAUG_WBy196R6wrbx4BDwHpvk1pLgIfy4UzNIiiFvh01IQ=)

 

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 of KidneyIntelX, the potential for KidneyIntelX to receive regulatory
approval from the FDA, the commercial prospects of KidneyIntelX, if approved,
including whether and to what extent KidneyIntelX will be successfully adopted
by physicians and distributed and marketed, our expectations regarding the
ability of KidneyIntelX 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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