10 Mar 2022 07:00
REDX PHARMA PLC
("Redx" or "the Company")
Redx Presents Encouraging Phase 1 Safety Data for RXC007
Data presented at ILD Summit shows this novel anti-fibrotic drug candidate possesses excellent safety and pharmacokinetic profile
Phase 2 study expected to commence in 2022
Alderley Park, 10 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, today announces encouraging data from the Phase 1 clinical study of its lead fibrosis asset, RXC007, which was presented at the Virtual Interstitial Lung Disease Drug Development (ILD) Summit on 9 March 2022 by Nicolas Guisot PhD, Research Fellow at Redx. Highlights from the data were also presented at the Cowen 42nd Annual Health Care Conference by Lisa Anson, Chief Executive Officer, on 9 March 2022.
The Phase 1 trial (clinicaltrials.gov NCT04931147) is evaluating the safety and tolerability of RXC007, an orally bioavailable selective ROCK2 (Rho Associated Protein Kinase 2) inhibitor, in healthy volunteers. Initial data from this study was presented at Redx's Virtual R&D Day in October 2021 and the data presented at the ILD Summit were from the now completed Phase 1 Single Ascending Dose (SAD) and multiple dose cohorts.
The data presented showed RXC007 has an excellent safety and pharmacokinetic profile in both the SAD and multiple dose phase. No adverse events were observed following single doses of 2-70mg (dosed once or twice in a day), and no serious adverse events were observed in the multiple dose phase (dosed at 50mg twice daily for 14 days), with only transient, reversible mild adverse events observed. The pharmacokinetics observed were as predicted from preclinical data, with essentially linear exposure for 2-70mg, with biologically relevant exposures achieved at higher doses. No significant effect on exposure was seen when dosed with food. The data also showed a half-life of approximately 9 hours, suitable for once-daily dosing.
Additional open-label cohorts will assess the potential for drug-drug interaction in Part C of the study, which has not yet opened.
Based on this profile, Redx confirms plans to commence a staged Phase 2 clinical development program for idiopathic pulmonary fibrosis in 2022. An initial 12-week randomised placebo-controlled Phase 2a study will assess early efficacy, safety and tolerability, in addition to target and disease biomarker engagement, both with and without standard of care agents. The Phase 2a dose-ranging study will inform the dose selection for subsequent randomised trials.
Lisa Anson, Chief Executive Officer of Redx Pharma, said: "Clinical data from our Phase 1 study suggests that RXC007 is safe and well-tolerated at the drug doses we have selected. Importantly, this data supports progressing into Phase 2 studies later this year to assess the safety and efficacy of RXC007 in patients with idiopathic pulmonary fibrosis, a disease with high unmet medical need."
For further information, please contact: |
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Redx Pharma Plc ir@redxpharma.com
UK Headquarters Lisa Anson, Chief Executive Officer | T: +44 (0)1625 469 918 | |||
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 Spång/ 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 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 program 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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