REG - Redx Pharma plc - Nomination of Clinical Development Candidate

Redx PharmaAnnouncement

30/03/2022 07:00

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RNS Number : 4701G  Redx Pharma plc  30 March 2022

REDX PHARMA PLC

("Redx" or "the Company")

 

Redx Nominates GI-targeted ROCK Inhibitor, RXC008, as Clinical Development
Candidate

 

RXC008 will be developed as a potential first in class treatment for
fibrostenotic Crohn's disease

 

RXC008 was designed to act exclusively in the GI tract, and has the potential
to halt or reverse disease progression, avoiding the need for surgical
intervention

 

Phase 1 clinical studies planned to commence at the end of 2023

 

Alderley Park, 30 March 2022 Redx (AIM: REDX), the clinical-stage
biotechnology company focused on discovering and developing novel, small
molecule, highly targeted therapeutics for the treatment of cancer and
fibrotic disease, is pleased to announce the nomination of RXC008, a potential
first in class treatment for fibrostenotic Crohn's disease, as its next
clinical development candidate. RXC008 is a Gastrointestinal (GI) targeted Rho
Associated Coiled-Coil Containing Protein Kinase (ROCK) inhibitor designed to
act exclusively in the GI tract at the site of fibrosis in Crohn's disease
patients.

 

Up to 50% of patients with Crohn's disease* can develop significant fibrosis
and stricture formation within ten years after diagnosis; this fibrosis
associated with Crohn's disease is known as fibrostenotic Crohn's Disease. The
current management of fibrotic strictures of the GI tract is primarily
surgical as no drugs are specifically approved for fibrosis, which can
progress despite intervention with anti-inflammatory therapies. RXC008 is
designed to work specifically at the site of fibrosis in the GI tract and to
degrade quickly, if absorbed into the bloodstream, through enzyme-mediated
metabolism. Preclinical data from Redx's GI-targeted ROCK inhibitor research
project shows strong anti-fibrotic therapeutic effects in multiple animal
models of inflammatory bowel disease. RXC008 could address the high unmet need
in the treatment of fibrostenotic Crohn's disease by potentially slowing or
reversing disease progression and avoiding the need for surgical intervention,
thereby improving patients' quality of life.

 

The Company plans to initiate a Phase 1 study with RXC008 at the end of 2023.
This programme will be the third development candidate that Redx has
progressed in the area of fibrosis. RXC007, an orally available, selective
ROCK2 inhibitor for development in idiopathic pulmonary fibrosis (IPF),
commenced first in human studies in June 2021 and RXC006, an orally available
porcupine inhibitor is being progressed in Phase 1 studies by AstraZeneca,
following a partnership deal in August 2020.

 

Lisa Anson, Chief Executive Officer of Redx, commented: "Crohn's disease
associated fibrosis is an area with high unmet need, with no treatment
currently available except for invasive surgery. We are therefore delighted to
announce this exciting new candidate, RXC008, which has the potential to help
address this high unmet need, as the latest novel drug development candidate
discovered by Redx. RXC008's progression demonstrates the power of our
discovery platform and further strengthens our clinical development pipeline
as we progress towards our goal of submitting three new INDs by 2025."

 

*Rieder et al, Gut. 2013 Jul; 62(7): 1072-1084.
doi:10.1136/gutjnl-2012-304353.

 

 For further information, please contact:

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

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

 UK Headquarters

 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 GI-targeted ROCK inhibitors

GI-targeted ROCK1/2 inhibition is a novel therapeutic approach where the drug
is selectively active only in the gut without material systemic exposure.
ROCK1 and ROCK2 are intracellular kinases with multiple functions, shown to be
implicated at various points in pathways leading to fibrosis. However,
systemic ROCK1/2 inhibitors (or pan-ROCK inhibitors) are known to induce
hypotension and are therefore unlikely to be tolerated by patients. Redx's
GI-targeted ROCK inhibitor is designed to only work at the site of action in
the GI tract and to degrade quickly, if absorbed into the bloodstream, through
enzyme-mediated metabolism. GI-targeted ROCK inhibitors are designed to reduce
or reverse fibrosis, prevent disease progression and avoid surgical
intervention, thereby improving patients' lives.

 

About Redx Pharma Plc

Redx Pharma (AIM: REDX) is a clinical-stage biotechnology company focused on
the discovery and development of novel, small molecule, highly targeted
therapeutics for the treatment of cancer and fibrotic diseases, aiming
initially to progress them to clinical proof of concept before evaluating
options for further development and potential value creation. Redx's lead
oncology product candidate, the Porcupine inhibitor RXC004, commenced a Phase
2 programme in November 2021. The Company's selective ROCK2 inhibitor product
candidate, RXC007, is in development for idiopathic pulmonary fibrosis and
commenced a Phase 1 clinical trial in June 2021. Encouraging safety and
pharmacokinetic data has been reported, and a Phase 2 clinical programme is
confirmed to start in 2022.

 

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 two wholly-owned clinical-stage
product candidates and rapidly expanding pipeline, but also by its strategic
transactions, including the sale of pirtobrutinib (RXC005, LOXO-305), a BTK
inhibitor now in Phase 3 clinical development by Eli Lilly following its
acquisition of Loxo Oncology and RXC006, a Porcupine inhibitor targeting
fibrotic diseases including idiopathic pulmonary fibrosis (IPF), which
AstraZeneca is progressing in a Phase 1 clinical study. In addition, Redx has
forged collaborations with Jazz Pharmaceuticals.

 

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(http://www.redxpharma.com/investor-centre/email-alerts/)

 

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