REG - Renalytix PLC - First use of KidneyIntelX in new CKD therapy trial

RenalytixAnnouncement

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RNS Number : 3033J  Renalytix PLC  20 May 2025

Renalytix plc

("Renalytix" or the "Company")

 

First use of KidneyIntelX in a clinical trial for new CKD therapy

 

Key milestone in partnered pharma programme with AION Healthspan

 

First patient treated in clinical trial of AION Healthspan`s novel
investigational cell therapy, REJUVXL(TM)

 

LONDON and NEW YORK, 20 May 2025 - Renalytix plc (LSE: RENX) (OTCQB: RNLXY), a
precision medicine company with lead testing service kidneyintelX.dkd, the
only FDA-approved and Medicare reimbursed prognostic test to support
early-stage risk assessment in chronic kidney disease, announces that a key
milestone has been reached in the very first use of KidneyIntelX in a clinical
trial, following the successful enrollment and treatment of the first patient
to determine the safety and efficacy of a novel cell therapy for patients with
Chronic Kidney Disease ("CKD").

 

Renalytix and AION Heathspan, Inc, a US-based clinical-stage biotech company
dedicated to advancing regenerative medicine for acute and chronic
degenerative diseases, are partnering in the use of KidneyIntelX as a
precision medicine solution in the clinical development programme for AION
Healthspan`s REJUVXL(TM) (AION-301), including helping monitoring of
therapeutic efficacy. This partnered programme represents the first instance
where KidneyIntelX is incorporated into a clinical trial of a new therapy in
CKD. Change in KidneyIntelX risk levels is included as an outcome measure in
this first-in-human clinical trial. Under the terms of the agreement,
Renalytix will be responsible for determining KidneyIntelX risk levels in
subjects enrolled in the study and supporting analysis of the data in
accordance with the clinical protocol.

 

The announcement from AION Healthspan can be viewed here:

https://www.wboy.com/business/press-releases/ein-presswire/813815808/aion-healthspan-announces-first-patient-treated-in-phase-i-ii-clinical-trial-for-cell-therapy-in-chronic-kidney-disease/
(https://urldefense.proofpoint.com/v2/url?u=https-3A__www.wboy.com_business_press-2Dreleases_ein-2Dpresswire_813815808_aion-2Dhealthspan-2Dannounces-2Dfirst-2Dpatient-2Dtreated-2Din-2Dphase-2Di-2Dii-2Dclinical-2Dtrial-2Dfor-2Dcell-2Dtherapy-2Din-2Dchronic-2Dkidney-2Ddisease_&d=DwMF-g&c=euGZstcaTDllvimEN8b7jXrwqOf-v5A_CdpgnVfiiMM&r=fSst1AtlXyuqcs3cHJXcCRilbI1Qm1WfjNYkVgQfiLE&m=SvC7EdzcFrWbZH2z02gFlKZmT4_TIoDaWMqBhSTPajZA5zGiwpQwzRLhqsP1h1AH&s=x4He815KbgSKvZLdlWvgvnDHGP-XzooxCeM538Wek0Q&e=)

 

Fergus Fleming, Chief Technology Officer of Renalytix, commented: "We are
delighted to congratulate AION on meeting this very significant milestone in
the development of their novel immunomodulatory and regenerative cell therapy
technology targeted at CKD. If successful, this therapy will add to the
growing therapeutic options for patients, further highlighting the need for
the KidneyIntelX precision medicine platform to accelerate clinical
development and enable optimized treatment and outcomes for patients.
Renalytix is in a strong position to support pharmaceuticals companies looking
to incorporate a precision medicine solution, like KidneyIntelX, into their
clinical development and commercial programmes, activity which supports the
increasing diversification of our revenue streams."

Giacomo Lanzoni, Chief Scientific Officer of AION Healthspan, Inc, stated: "We
are thrilled to partner with Renalytix in our first‐in‐human clinical
trial of REJUVXL™, and to be the first cell therapy development program to
leverage KidneyIntelX for risk stratification and analyses of efficacy.
Integrating this robust biomarker strategy into our protocol will deepen our
understanding of patient response and safety, and accelerate our path toward
truly personalized regenerative treatments for chronic kidney disease."

 

Further information on AION Healthspan, REJUVXL(TM), and the active clinical
trial can be found below:

https://clinicaltrials.gov/study/NCT06721143/
(https://clinicaltrials.gov/study/NCT06721143/)

 

This announcement contains inside information for the purposes of Article 7 of
Regulation (EU) 596/2014, as it forms part of domestic law by virtue of the
European Union (Withdrawal) Act 2018.

 

 

For further information, please contact:

 

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

 Stifel (Nominated Adviser and Joint Broker)               Tel: 020 7710 7600
 Nicholas Moore / Nick Harland / Brough Ransom / Ben Good

 Oberon Capital (Joint Broker)                             Tel: 020 3179 5300
 Mike Seabrook / Nick Lovering

 Walbrook PR Limited                                       Tel: 020 7933 8780 or renalytix@walbrookpr.com
 Paul McManus / Alice Woodings                             Mob: 07980 541 893 / 07407 804 654

 

About Renalytix (www.renalytix.com (http://www.renalytix.com) )

Renalytix (LSE: RENX) (OTCQB: RNLXY) is an artificial intelligence-enabled in
vitro diagnostics company, focused on optimizing clinical management of kidney
disease to drive improved patient outcomes. Renalytix has received FDA
approval and Medicare reimbursement for kidneyintelX.dkd which is now offered
commercially in the United States.

 

Unrecognized and uncontrolled kidney disease remains one of the largest
barriers to controlling cost and suffering in the United States and the United
Kingdom's medical system, affecting over 14 million and 8 million people,
respectively. After five years of development and clinical validation,
kidneyintelX.dkd is the only FDA-approved and Medicare reimbursed prognostic
tool capable of understanding a patient's risk with kidney disease early where
treatment has maximal effect. kidneyintelX.dkd is now being deployed across
large physician group practices and health systems in select regions of the
United States.

 

The over 15,000 patients that have been tested by kidneyintelX.dkd have
produced a substantial body of real-world performance data. In patient
populations where kidneyintelX.dkd has been deployed, a demonstrated and
significant increase in diagnosis, prognosis, and treatment rates have been
recorded. kidneyintelX.dkd now has full reimbursement established by Medicare,
the largest insurance payer in the United States, at $950 per reportable
result. kidneyintelX.dkd is also recommended for use in the international
chronic kidney disease clinical guidelines (KDIGO).

 

KidneyIntelX is based on technology developed by Mount Sinai faculty and
licensed to Renalytix AI, Inc. Mount Sinai faculty members are co-founders and
equity owners in the Company. In addition, the Icahn School of Medicine at
Mount Sinai has equity ownership in Renalytix.

 

About AION Healthspan, Inc. (www.aionhealthspan.com
(http://www.aionhealthspan.com) )

AION Healthspan, Inc. is a clinical-stage biotechnology company dedicated to
advancing regenerative medicine for acute and chronic degenerative diseases.
Built on decades of pioneering cell therapy research at the Diabetes Research
Institute Cell Transplant Center, University of Miami Miller School of
Medicine, AION Healthspan is led by a team of world-renowned scientists and
industry leaders.

 

AION's proprietary technology platform, REJUVXL™, targets inflammation,
fibrosis, immunity, and aging at the cellular level. While its first clinical
focus is on CKD, AION Healthspan plans to expand into additional indications.

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