Redx Pharma Regulatory News (REDX)

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.

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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