Redx Pharma Regulatory News (REDX)

REDX PHARMA PLC

("Redx" or "the Company")

First RXC006 data suggests it has great potential for the treatment of fibrosis

First-in-man studies earmarked for 2020

Alderley Park, 30 November 2018 Redx (AIM: REDX), the drug discovery and development company focused on cancer and fibrosis, announces that it presented pre-clinical data for its newly nominated development candidate RXC006 at the Advances in Fibrosis Drug Discovery Conference in Cambridge, USA on 29 November 2018. RXC006, a novel inhibitor of the porcupine enzyme, will be developed as an orally administered, first-in-class treatment for the orphan disease, idiopathic pulmonary fibrosis (IPF). IPF is a severe and life-threatening chronic lung condition with very poor prognosis and limited treatment options. The company expects to commence first-in-man studies with RXC006 during 2020.

In the first public disclosure of data on RXC006, Dr Peter Bunyard, Head of Fibrosis at Redx, presented results from preclinical studies in a plenary session as well as a poster which showed that RXC006 was highly effective at suppressing the Wnt pathway (porcupine sits on the Wnt pathway) and that RXC006 was able to suppress lung fibrosis, in vivo. Suppression of fibrosis has also been shown in animal models of both liver and kidney fibrosis.

More specifically, it was shown that RXC006 was able to suppress the release of Wnt-5a (another protein on the Wnt pathway) from human lung fibroblasts at nanomolar concentrations and reduce fibroblast activation. In two separate mouse models of disease, RXC006 strongly reduced collagen deposition and significantly impacted Ashcroft scores (a validated scale for estimating the severity of pulmonary fibrosis), when dosed therapeutically.

Dr Jörg Distler, Professor of Internal Medicine, University of Erlangen-Nuremberg, Germany and a key opinion leader in the development of novel anti-fibrotic therapies, commented: "Wnt pathway inhibition presents a novel and exciting opportunity to treat fibrotic diseases, I truly support the idea of targeting the porcupine enzyme."

Dr Richard Armer, Chief Scientific Officer, Redx Pharma plc added: "The data suggests that RXC006 has great potential to treat fibrosis in human patients. Redx are progressing RXC006 towards the clinic for the treatment of Idiopathic Pulmonary Fibrosis and plan to initiate first in man clinical trials during 2020."

There is strong scientific evidence that the Wnt pathway is critically involved in the scarring process (fibrosis) in the lung that is the hallmark of IPF.1 Over time, this leads to the lungs being unable to function effectively, ultimately resulting in suffocation and death. RXC006 represents a novel approach to treat this debilitating and progressive disease through targeting porcupine, a component enzyme of the Wnt pathway. Porcupine inhibition suppresses the release of all Wnt ligands and therefore should eliminate one of the major drivers of fibrosis in IPF. The median survival from IPF diagnosis is 3 years and the annual incidence is between 6.8-16.3/100,000 population in the U.S.2

The poster presentation is available via this link here: RXC006 AFDD Meeting Poster.

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About Redx Pharma Plc 

Redx is a UK based biotechnology company whose shares are traded on AIM (AIM:REDX). Redx's vision is to become a leading biotech focused on the development of novel precision medicines that have the potential to transform treatment in oncology and fibrotic diseases.

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About IPF

IPF is a life threatening fibrotic lung condition with diagnosed prevalence projected to increase from 119,000 (2015) to 138,000 (2025). Current treatment options are OFEV®(nintedanib) and Esbriet® (pirfenidone); both slow progression of disease by approximately 50%. Product sales in IPF are projected to increase from US$ 0.9b (2015) to US$3.2b (2025). 2

About RXC006

Redx has invested into research to target the Wnt /ß-Catenin signalling pathway by inhibition of the upstream porcupine enzyme and has built considerable knowledge and expertise in this scientific area. Our most advanced porcupine inhibitor, RXC004, is currently being investigated clinically for the treatment of a range of cancers. RXC006 is a potent porcupine inhibitor protected by discrete Intellectual Property and has a predicted human PK profile which will allow flexibility in dosing regimens to balance efficacy with potential side effects. RXC006 is the first porcupine inhibitor aimed at treating IPF.

References

1. Newman DR, Sills WS, Hanrahan K, Ziegler A, Tidd KM, Cook E, Sannes PL.

Expression of WNT5A in Idiopathic Pulmonary Fibrosis and Its Control by TGF-β and WNT7B in Human Lung Fibroblasts. J Histochem Cytochem. 2016 Feb;64(2):99-111.

2. Global Data Opportunity Analyser 2015, based on 7 major markets