REDX.L Regulatory News (REDX)

REDX PHARMA PLC

("Redx" or "the Company")

Redx Announces First Patient Dosed in Phase 2a Trial for RXC007 

Study in idiopathic pulmonary fibrosis patients to assess early signals of efficacy, safety and tolerability

RXC007 is Redx's second wholly-owned compound to enter Phase 2 clinical studies

Alderley Park, UK, 11 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, announces the first patient has been dosed in the Phase 2a study assessing RXC007, a wholly-owned Rho Associated Coiled-Coil Containing Protein Kinase 2 (ROCK2) selective inhibitor, as a potential treatment for patients with idiopathic pulmonary fibrosis (IPF). 

The Phase 2a study is a 12-week multi-cohort, randomised, double-blind, placebo-controlled dose ranging study to assess early signals of efficacy as well as the safety and tolerability of RXC007 in IPF patients. Both treatment-naïve patients and patients already on approved IPF therapy will be included in the study. Key endpoints for the study will be safety and pharmacokinetic profile; changes from baseline in lung function of forced vital capacity (FVC) and carbon monoxide diffusion coefficient (DLCO); and changes from baseline in Quantative Lung Fibrosis Score (QLFS), airway volume and resistance on high resolution computerised tomography (HRCT) scan.

In the study three dose escalation cohorts of 16 patients will be assigned a dosing period of three months, with patients potentially continuing for longer if they are seen to be tolerating their assigned treatment and there are no signs of disease progression. 

A translational science sub-study will commence in parallel to evaluate target engagement and disease interaction. Endpoints for this sub-study will include changes from baseline in blood biomarkers, proteins and genes from broncho-alveolar lavage (BAL) fluid, BAL-fluid cells and bronchial epithelial cells.

It is anticipated that headline data from the Phase 2a study will be available in H2 2023.

Lisa Anson, Chief Executive Officer, Redx Pharma commented: "We are extremely pleased to commence this Phase 2a trial for RXC007 in IPF, a truly devastating, rapidly progressing and ultimately deadly disease, where there are few treatment options. ROCK2 is a biologically-validated target shown preclinically to reduce fibrosis, the key pathology of IPF. The encouraging preclinical and translational data for RXC007 have given us confidence to progress into a Phase 2 programme with IPF as the lead indication.

"RXC007 will be the second wholly-owned Redx programme to enter Phase 2 clinical studies, reflecting our strong progress as a Company. It is one of five compounds to come from the Redx discovery engine that are currently at the clinical development stage, a testament to the strength of our world-class medicinal chemistry expertise and drug discovery capabilities."  

Prof Philip Molyneaux, the Asthma and Lung UK Chair of Respiratory Research and director of the NIHR Cardiorespiratory Clinical Research Facility at the Royal Brompton Hospital, the Chief Investigator for the RXC007 trial in the UK, commented: "IPF is a chronic disease with significant unmet medical need and limited therapeutic treatment options. ROCK, a known masterswitch in the fibrotic signalling pathway, is a promising target, which is heavily upregulated in IPF patients but has historically been very difficult to selectively inhibit. RXC007 Phase 1 data showed an excellent safety and pharmacokinetic profile in both the single ascending dose and multiple dose phase, and I look forward to supporting this Phase 2 trial."

About RXC007

RXC007 is an orally available, highly selective small molecule inhibitor that targets Rho Associated Coiled- Coil Containing Protein Kinase 2 (ROCK2) which sits at a nodal point in a cell signalling pathway, believed to be central to fibrosis. ROCK2 selectivity is important to avoid systemic hypotension, a serious cardiovascular side effect which has been seen in product candidates that systemically inhibit both ROCK1 and ROCK2. As a selective ROCK2 inhibitor, RXC007 has the potential to treat several fibrotic diseases and has demonstrated robust anti-fibrotic effects in a range of industry-standard in vivo preclinical models, results of which were recently presented at the International Colloquium on Lung and Airway Fibrosis (ICLAF) Redx intends to evaluate RXC007 initially as a treatment for idiopathic pulmonary fibrosis (IPF), a severe and life-threatening chronic lung condition with limited treatment options, which is estimated to affect 170,000(1) patients globally. IPF has an addressable market opportunity estimated to be worth $3.6 billion by 2029(1).

About Idiopathic Pulmonary Fibrosis

Fibrosis is an internal scarring process, which can occur in response to injury, where excess connective tissue is deposited in an organ or tissue, thereby impairing its function. Most chronic inflammatory diseases will result in fibrosis, with progressive injury resulting in organ failure. Idiopathic pulmonary fibrosis refers to scarring in the lungs which leads to difficulty in breathing. The specific cause of fibrosis is not known, but it can occur as a result of many different diseases and underlying health issues, including obesity or diabetes. Current therapeutic options are limited for these chronic and often life-threatening diseases.

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 interstitial lung disease and commenced a Phase 2a trial for idiopathic pulmonary fibrosis in October 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 an early stage oncology research collaboration.

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1 GlobalData IPF report 2019. IPF Market size forecast data sourced from Global Data (based on 7-8 major markets/2029 estimates)