Redx Presents RXC007 Preclinical and Phase 1 Data

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/

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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