TIDMRENX
RNS Number : 7551W
Renalytix AI PLC
21 August 2020
Renalytix AI plc
("RenalytixAI", the "Company")
RenalytixAI to Collaborate with AstraZeneca to Improve
Outcomes
for Patients with Chronic Disease
Parties to adopt multi-phase approach to develop precision
medicine strategies to optimize treatment of cardiovascular, renal
and metabolic disease
NEW YORK, August 21, 2020 - Renalytix AI plc ( LSE: RENX)
(NASDAQ: RNLX), today announced a collaboration with AstraZeneca
(LSE/STO/NYSE: AZN) to develop and launch precision medicine
strategies for cardiovascular, renal and metabolic diseases. The
first stage in the collaboration will use KidneyIntelX, an
artificial intelligence-enabled in vitro diagnostic platform, to
examine further improving outcomes for patients with chronic kidney
disease (CKD) and its complications, in coordination with the Mount
Sinai Health System. The goal of the first stage is to help improve
guideline-based standard-of-care for optimal utilization of
existing and novel therapeutics using the KidneyIntelX testing
platform and proprietary care management software.
An estimated 700 million patients worldwide have CKD,(1) which
is also associated with an increased risk of metabolic and
hematologic complications, such as hyperkalemia (elevated levels of
potassium in the blood) and anemia.(2,3)
The first stage will assess the impact of AI-enabled in vitro
diagnostic solutions to optimize utilization of therapeutics in CKD
under current standard of care protocols. Based on study outcomes,
a multi-center, randomized controlled trial will be initiated to
evaluate uptake and adherence to new potassium-binding agents in
patients with CKD and hyperkalemia. The studies will be conducted
in coordination with the Mount Sinai Health System, where
KidneyIntelX testing and care management software are currently
being deployed for commercial clinical use.
"We believe this collaboration will define how we can leverage
KidneyIntelX to improve the care and outcomes for patients affected
by chronic diseases, such as kidney disease, diabetes, and
cardiovascular disease ," said Barbara Murphy, MD, Chair of the
Samuel Bronfman Department of Medicine, Dean for Clinical
Integration and Population Health Management at the Icahn School of
Medicine at Mount Sinai, and board member of RenalytixAI . "By
using a more personalized approach, our initial goal is to help
realize improved outcomes for more than 240,000 patients with
chronic kidney disease within the Mount Sinai Health System."
RenalytixAI and AstraZeneca will use KidneyIntelX with the aim
to:
-- Help improve physician uptake and patient adherence to
existing potassium-binding therapeutics and other approved products
in CKD through early identification of previously hidden high-risk
patient groups
-- Accelerate patient identification and recruitment for clinical trials
-- Complement commercialization efforts with outcomes from KidneyIntelX results
"This collaborative approach reflects the shared vision of
AstraZeneca and RenalytixAI to develop meaningful solutions to
tackle significant challenges in healthcare in a holistic way,"
said Tarek Rabah, Vice President, AstraZeneca US Renal-Cardio. "We
are committed to revolutionizing kidney care by continuing to drive
innovation. An important component of our work is identifying
patients with significant unmet need and providing them with more
personalized interventions."
Results from the program are anticipated in early 2021.
For further information, please contact:
Renalytix AI plc www.renalytixai.com
James McCullough, CEO Via Walbrook PR
Stifel (Nominated Adviser, Joint Broker Tel: 020 7710 7600
)
Alex Price / Nicholas Moore
N+1 Singer (Joint Broker) Tel: 020 7496 3000
Aubrey Powell / George Tzimas (Corporate
Finance)
Tom Salvesen (Corporate Broking)
Walbrook PR Limited Tel: 020 7933 8780 or renalytix@walbrookpr.com
Paul McManus / Lianne Cawthorne Mob: 07980 541 893 / 07584
391 303
About Chronic Kidney Disease
CKD is a serious, progressive condition defined by decreased
kidney function (shown by reduced eGFR or markers of kidney damage,
or both, for at least three months).(5) I n the United States
alone, nearly 37 million American adults (15%) currently have
CKD.(6) Meanwhile, on a global scale, the total number of
individuals with CKD, acute kidney injury (AKI), and those on renal
replacement therapy (RRT) exceeds 850 million.(7)
The disease often has no symptoms in its early stages and can go
undetected until it is very advanced requiring dialysis or a kidney
transplant. The Centers for Disease Control and Prevention (CDC)
reports that 9 out of 10 adults with CKD go undiagnosed, and half
of patients with very low kidney function, who are not on dialysis,
do not know they have CKD.(6) For this reason, kidney disease is
often referred to as a "silent disease."(8)
As kidney function declines, patients face an increased risk of
developing other associated CKD complications, such as anemia or
hyperkalemia.(2,3) Anemia is a serious medical condition in which
patients have insufficient red blood cells and low levels of
hemoglobin ("Hb"), a protein in red blood cells that carries oxygen
to cells throughout the body.(3) If left untreated, anemia of CKD
can cause increased hospitalization, morbidity and mortality.(9)
Hyperkalemia can also be a dangerous condition, characterized by
elevated potassium levels in the blood.(2) If left untreated, it
can cause an irregular heartbeat and can be fatal.
About RenalytixAI
We are a commercial-stage artificial intelligence-enabled in
vitro diagnostics company, focused on optimizing clinical
management in chronic kidney disease to help drive improved patient
outcomes and significantly lower healthcare costs. KidneyIntelX,
our first-in-class diagnostic platform, employs a proprietary
artificial intelligence-enabled algorithm that combines diverse
data inputs, including validated blood-based biomarkers, inherited
genetics and extensive personalized patient data from electronic
health record systems to generate a unique patient risk score.
KidneyIntelX is based on technology developed by Mount Sinai
faculty and licensed to RenalytixAI. Mount Sinai and Mount Sinai
faculty, including a small number of inventors and Barbara Murphy,
MD, have a financial interest in RenalytixAI.
About the Mount Sinai Health System
The Mount Sinai Health System is New York City's largest
academic medical system, encompassing eight hospitals, a leading
medical school and a vast network of ambulatory practices
throughout the greater New York region. Mount Sinai is a national
and international source of unrivaled education, translational
research and discovery and collaborative clinical leadership
ensuring that we deliver the highest quality care-from prevention
to treatment of the most serious and complex human diseases. The
Health System includes more than 7,200 physicians and features a
robust and continually expanding network of multispecialty
services, including more than 400 ambulatory practice locations
throughout the five boroughs of New York City, Westchester and Long
Island. The Mount Sinai Hospital is ranked No. 14 on U.S. News
& World Report 's "Honor Roll" of the Top 20 Best Hospitals in
the country and the Icahn School of Medicine as one of the Top 20
Best Medical Schools in country. Mount Sinai Health System
hospitals are consistently ranked regionally by specialty and our
physicians are in the top 1% of all physicians nationally by U.S.
News & World Report .
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: our ability to improve outcomes for
patients with chronic disease and develop precision medicine
strategies to optimize treatment of cardiovascular, renal and
metabolic disease, as well as the anticipated benefits of the
collaboration with AstraZeneca, including optimizing utilization of
existing and novel therapeutics, accelerating patient
identification and recruitment for clinical trials and
complementing commercialization efforts. 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 not yet 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 final prospectus filed with the Securities and Exchange Commission (SEC) on July 17, 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:
RenalytixAI United States:
Jennifer Moritz
Zer0 to 5ive for RenalytixAI
(917) 748-4006
jmoritz@0to5.com
Mount Sinai Hospital System
Phone: +1 212-241-9200
Email: NewsMedia@mssm.edu
References:
1. Global, regional, and national incidence, prevalence, and
years lived with disability for 354 diseases and injuries for 195
countries and territories, 1990-2017: asystematic analysis for the
Global Burden of Disease Study 2017.The Lancet. 2018; 392:1789-858.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)32279-7/fulltext#seccestitle10.
Published November 10, 2018. Accessed August 4, 2020.
2. National Kidney Foundation. Clinical Update on Hyperkalemia. 2016. https://www.kidney.org/sites/default/files/02-10-7260%20Clinical%20Bulletin.pdf
3. National Institute of Diabetes and Digestive and Kidney
Disease. Anemia in Chronic Kidney Disease.
https://www.niddk.nih.gov/health-information/kidney-disease/anemia#::text=What%20causes%20anemia%20in%20chronic,
of%20the%20oxygen%20it%20needs. Published November 8, 2014.
Accessed August 4, 2020.
4. Desai NR, Reed P, Alvarez PJ, et al. The Economic
Implications of Hyperkalemia in a Medicaid Managed Care Population.
American Health & Drug Benefits. 2019.12(7)352-361.
http://www.ahdbonline.com/issues/2019/november-2019-vol-12-no-7/2862-the-economic-implications-of-hyperkalemia-in-a-medicaid-managed-care-population.
Accessed August 4, 2020.
5. Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work
Group. KDIGO 2012 clinical practice guideline for the evaluation
and management of chronic kidney disease. Kidney International
Supplement 2013; (3):1-150. Accessed August 4, 2020.
6. Centers for Disease Control and Prevention. Chronic Kidney
Disease in the United States, 2019. Atlanta, GA: US Department of
Health and Human Services, Centers for Disease Control and
Prevention; 2019. Accessed August 4, 2020.
7. A Hidden Epidemic: More than 850 Million Suffer from Kidney
Diseases Worldwide, Organizations Report. ASN Kidney News.
https://www.kidneynews.org/kidneynews/10_8/4/4.pdf. Published
August 2018. Accessed August 4, 2020.
8. National Institute of Diabetes and Digestive and Kidney
Disease. Kidney Disease Statistics for the United States.
https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease.
Updated 2020. Accessed August 4, 2020.
9. Thorp M, Johnson S, Yang X, et al. Effect of anaemia on
mortality, cardiovascular hospitalizations and end-stage renal
disease among patients with chronic kidney disease. APSN.
2009;14(2):240-246. doi:10.1111/j.1440-1797.2008.01065.x.
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END
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