RCS - Redx Pharma plc - Redx Unveils Preclinical Data from RXC009

Redx PharmaAnnouncement

06/11/2023 07:15

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RNS Number : 3927S  Redx Pharma plc  06 November 2023

REDX PHARMA PLC

 

("Redx" or the "Company")

 

Redx Unveils Preclinical Data from New Development Candidate, RXC009, a Novel,
Selective Discoidin Domain Receptor 1 Inhibitor

 

Data from translational disease models supports development of RXC009 as a
potential first-in-class treatment for chronic kidney disease

 

Alderley Park, UK, 6 November 2023 Redx (AIM:REDX), the clinical-stage
biotechnology company focused on discovering and developing novel, small
molecule, targeted therapeutics for the treatment of fibrotic disease and
cancer announces preclinical data for RXC009, a recently nominated development
candidate from its Discoidin Domain Receptor (DDR) programme, was presented at
the American Society for Nephrology (ASN) Annual Meeting (2-5 November 2023,
Philadelphia, US).

 

RXC009, a small molecule, orally available, highly potent and selective DDR1
inhibitor, was nominated as a development candidate in October 2023 and has
potential to be a first-in-class treatment option for chronic kidney disease
(CKD) including kidney fibrosis associated with CKD as seen in Alport
Syndrome. DDRs have recently gained traction as druggable targets with the
potential to treat multiple fibrotic conditions, however to date, no selective
inhibitors of DDR1 have entered the clinic.

 

RXC009 demonstrated excellent selectivity for DDR1 compared to other disclosed
DDR inhibitors when tested against kinase and other target panels with limited
off-target pharmacology. In a therapeutic unilateral ureteral obstruction
(UUO) murine model of kidney fibrosis, RXC009 treatment resulted in a
significant reduction in histological markers of both inflammation and
fibrosis. Target engagement was also demonstrated in this model with a 72%
reduction in phospho-DDR1 (p-DDR1). RXC009 has a favourable absorption,
distribution, metabolism and excretion (ADME) and safety profile with a
Drug-Drug Interaction (DDI) assessment completed confirming its suitability
for potential use in combination. These data further validate the hypothesis
that selective inhibition of DDR1 represents an attractive approach for
investigation towards the development of new treatments for CKD and taken
collectively, supports progressing RXC009 into IND-enabling studies.

 

Richard Armer, Chief Scientific Officer, Redx Pharma, commented: "This
compelling preclinical data suggests that our selective DDR1 inhibitor,
RXC009, has the potential to be a first-in-class treatment with an initial
indication in chronic kidney disease and associated fibrosis, which remains a
significant unmet medical need. The nomination of our 10(th) development
candidate again highlights our medicinal chemistry expertise and unique
ability to develop novel drug candidates against historically challenging
disease targets."

 

As previously announced, the Company intends to partner its DDR programme for
further development as it focuses on advancing its differentiated ROCK
portfolio through clinical development.

 

About CKD and Alport Syndrome

CKD affects 8% to 16% of the population worldwide and is most commonly
attributed to diabetes and hypertension. Renal fibrosis, characterised by
tubulointerstitial fibrosis and glomerulosclerosis, is one of the final
manifestations of CKD as it progresses and is associated with high
morbidity(1).

 

Alport Syndrome is an inherited disease that damages the tiny blood vessels in
the kidneys and can lead to kidney disease and kidney failure. There is no
specific approved treatment for Alport Syndrome, with current standard of care
aiming to treat the symptoms and help slow the progression of kidney
disease(2). While there are no reliable prevalence studies are available,
Alport Syndrome is estimated to affect less than 200,000 people in the
U.S.(3), making it a rare disease.

 

 For further information, please contact:

 Redx Pharma Plc                                                      T: +44 (0)1625 469 918

 UK Headquarters

 Caitlin Pearson, Head of Communications

 ir@redxpharma.com (mailto:ir@redxpharma.com)

 Lisa Anson, Chief Executive Officer

 US Office

 Peter Collum, Chief Financial Officer

 SPARK Advisory Partners (Nominated Adviser)                          T: +44 (0)203 368 3550
 Matt Davis/ Adam Dawes

 WG Partners LLP (Joint Broker)                                       T: +44 (0)203 705 9330
 Claes Spång/ Satheesh Nadarajah/ David Wilson

 Panmure Gordon (UK) Limited (Joint Broker)                           T: +44 (0)207 886 2500
 Rupert Dearden/ Freddy Crossley/ Emma Earl

 FTI Consulting                                                       T: +44 (0)203 727 1000
 Simon Conway/ Ciara Martin

 

About Redx Pharma Plc

Redx Pharma (AIM: REDX) is a clinical-stage biotechnology company focused on
the discovery and development of novel, small molecule, targeted therapeutics
for the treatment of fibrotic disease, cancer and the emerging area of
cancer-associated fibrosis, aiming initially to progress them to clinical
proof of concept before evaluating options for further development and
potential value creation. The Company's lead fibrosis product candidate, the
selective ROCK2 inhibitor, zelasudil (RXC007), is in development for
interstitial lung disease and is undergoing a Phase 2a trial for idiopathic
pulmonary fibrosis (IPF) with topline data expected in H1 2024. The Company's
second fibrosis candidate, RXC008, a GI-targeted ROCK inhibitor for the
treatment of fibrostenotic Crohn's disease, is progressing towards a CTA
application during the fourth quarter of 2023. Redx's lead oncology product
candidate, the Porcupine inhibitor RXC004, being developed as a targeted
treatment for Wnt-ligand dependent cancers, is expected to report anti-PD-1
combination Phase 2 data during the first half of 2024, following which Redx
will seek a partner for ongoing development. In October 2023, Redx nominated
its next development candidate, RXC009 a highly potent and selective DDR1
inhibitor for the treatment of chronic kidney disease and associated
fibrosis.

 

The Company has a strong track record of discovering new drug candidates
through its core strengths in medicinal chemistry and translational science,
enabling the Company to discover and develop differentiated therapeutics
against biologically or clinically validated targets. The Company's
accomplishments are evidenced not only by its wholly-owned clinical-stage
product candidates and discovery pipeline, but also by its strategic
transactions, including the sale of pirtobrutinib (RXC005, LOXO-305), a
non-covalent (reversible) BTK inhibitor now approved by the US FDA for adult
patients with mantle cell lymphoma previously treated with a covalent BTK
inhibitor, and AZD5055/RXC006, a Porcupine inhibitor targeting fibrotic
diseases including IPF, which AstraZeneca is progressing in a Phase 1 clinical
study. In addition, Redx has forged collaborations with Jazz Pharmaceuticals,
which includes JZP815, a pan-RAF inhibitor developed by Redx which Jazz is now
progressing through Phase 1 clinical studies, and an early-stage oncology
research collaboration.

 

To subscribe to Email Alerts from Redx, please visit:
www.redxpharma.com/investor-centre/email-alerts/
(http://www.redxpharma.com/investor-centre/email-alerts/) .

 

 

1. Taken in part from Chen TK et al; JAMA. 2019 Oct 1; 322(13): 1294Ð1304.
(https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&retmode=ref&cmd=prlinks&id=31573641)

2. https://www.kidney.org/atoz/content/alport
(https://www.kidney.org/atoz/content/alport)

3. https://alportsyndrome.org/about-alport-syndrome/
(https://alportsyndrome.org/about-alport-syndrome/)

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