REG - Redx Pharma plc - Redx Presents RXC007 Preclinical and Phase 1 Data

Redx PharmaAnnouncement

03/10/2022 07:00

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RNS Number : 4572B  Redx Pharma plc  03 October 2022

REDX PHARMA PLC

("Redx" or "the Company")

Redx Presents Preclinical Data Confirming Anti-Fibrotic Effects of RXC007 in
Immune Mediated Models, and Final Phase 1 Safety Data

Preclinical data presented at ICLAF showed pleiotropic effects of RXC007 in
GvHD model

Phase 1 data confirmed RXC007 is safe and well-tolerated

Alderley Park, UK, 3 October 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, today announces preclinical efficacy data in immune mediated
models for RXC007. The data on RXC007, the Company's lead fibrosis asset, was
presented alongside encouraging final Phase 1 safety and pharmacokinetic data
at the International Colloquium on Lung and Airway Fibrosis (ICLAF) on 2
October by Dr Nicolas Guisot, Research Fellow at Redx.

 

The data presented showed the pleiotropic, anti-fibrotic effects of RXC007, an
orally bioavailable selective ROCK2 (Rho-Associated Protein Kinase 2)
inhibitor in murine bleomycin-induced lung fibrosis and in murine
sclerodermatous chronic graft versus host disease (GvHD) models. The murine
sclerodermatous cGvHD model recapitulates aspects of human scleroderma with
prominent skin thickening, lung fibrosis, and upregulation of cutaneous
collagen. Furthermore, the underlying disease mechanisms that drive pathology
in the model show similarities to those observed in auto-immune driven
fibrotic diseases such as systemic sclerosis and interstitial lung disease
(ILD).

 

RXC007, dosed orally and therapeutically, was able to significantly reduce
skin thickness, fibrosis and collagen deposition in the skin and lungs as
measured by hydroxyproline (a key fibrotic marker), histological staining and
scoring (Trichome, H&E and Ashcroft score).

 

RXC007 is currently in development for lung fibrosis, including idiopathic
pulmonary fibrosis (IPF) and auto-immune related interstitial lung disease
(ILD), and the poster also discussed Phase 1 safety data in healthy volunteers
which highlighted an excellent safety and pharmacokinetic profile.

 

No adverse events were observed in the Single Ascending Dose phase, following
single doses of 2-70 mg (dosed once or twice in a day), and no serious adverse
events were observed in the multiple dose phase (dosed at 50 mg twice daily
for 14 days), with only transient, reversible, mild adverse events observed.
The pharmacokinetics were as predicted from preclinical data, with linear
exposure for 2-70 mg, and biologically relevant exposures achieved from 20 mg.
No significant effect on exposure was seen when dosed with food. The data also
showed a half-life of approximately 9-11 hours, suitable for once-daily
dosing.

 

Redx has previously confirmed plans for a staged Phase 2 clinical development
program in IPF. A 12-week randomised placebo-controlled Phase 2a dose-ranging
study assessing early efficacy, safety and tolerability, in addition to target
and disease biomarker engagement, both with and without standard of care
agents, is expected to commence in Q4 2022. Topline data from this study is
expected to be available in H2 2023. The Phase 2a study will inform the dose
selection for a subsequent larger Phase 2b 12-month study.

 

Dr Jane Robertson, Chief Medical Officer, Redx, commented: "We are excited by
this new preclinical data which supports our current and future clinical
development plans. RXC007 has now shown anti-fibrotic effects in a range of
preclinical models which, combined with the encouraging Phase 1 safety and
pharmacokinetic profile, underpins our plan to commence a Phase 2a trial in
IPF during Q4 2022. IPF only accounts for about a third of patients who have
significant fibrotic lung pathology, and this new preclinical data supports
broader clinical development of RXC007 in lung fibrosis including progressive
fibrotic interstitial lung disease, which we intend to explore during our
future Phase 2b study."

 

A full copy of the poster presented can be found on the Company's website:
https://www.redxpharma.com/scientific-publications/
(https://www.redxpharma.com/scientific-publications/)

 

 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 SpŒng/ 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, 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 lead fibrosis product candidate,
the selective ROCK2 inhibitor 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 program is confirmed to start in 2022. Redx's third drug candidate,
RXC008, a GI-targeted ROCK inhibitor for the treatment of fibrostenotic
Crohn's disease, is currently in pre-IND stage, with Phase 1 clinical studies
expected to commence in 2023.

 

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 AZD5055/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, which includes
JZP815, a preclinical pan-RAF inhibitor, which has received IND clearance from
the US FDA, and a further oncology programme which is in early stage
research.

 

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www.redxpharma.com/investor-centre/email-alerts/

 

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