- RTX001 is the first engineered Regenerative Macrophage Therapy (RMT) to be evaluated in humans with advanced liver fibrosis
- First patient has successfully cleared safety period with no serious adverse events
- Enrolment is now open for the study, with initial data readout expected in 2026
EDINBURGH, Scotland and LONDON, Sept. 3, 2025 /PRNewswire/ --Resolution Therapeutics ("Resolution" or "Company"), a clinical-stage biopharmaceutical company focused on pioneering Regenerative Macrophage Therapy to treat inflammatory and fibrotic diseases, today announces that the first patient has been dosed and safety cleared in its Phase I/II EMERALD study. EMERALD is evaluating RTX001, a first-in-class engineered RMT for patients with a history of decompensated liver cirrhosis. Following this success, the study is now open for full enrolment in the UK and Spain.
As the first-in-human administration of an engineered RMT, RTX001 represents a breakthrough in the development of this novel therapeutic modality in patients with end-stage liver disease.
Dr Amir Hefni, Chief Executive Officer of Resolution Therapeutics, said: "The first patient dosed represents a significant milestone in advancing RTX001 as a potential first-in-class treatment option for patients with end-stage liver disease, a condition with high mortality and severely limited therapeutic options. We look forward to reporting our first clinical readouts from the EMERALD study in 2026."
The Phase I/II EMERALD study is a multi-centre, single-arm, first-in-human, open-label study designed to evaluate the safety and efficacy of RTX001 in patients with end-stage liver disease who have recovered from a recent hepatic decompensation. The study is being conducted at leading hepatology centres across the UK and Spain and will enrol up to 25 patients, with the first patient dosed at the Royal Infirmary of Edinburgh.
"Most liver-related hospitalisations and deaths result from decompensated cirrhosis, yet there are no licensed therapies that stabilise or reverse disease at this late stage. Liver transplantation is effective but limited by donor availability, cost, and suitability for only a small subset of patients" said Professor Jonathan Fallowfield, Chair of Translational Liver Research and Principal Investigator at the University of Edinburgh, Honorary Consultant Hepatologist at the Royal Infirmary of Edinburgh, and Chief Investigator of the EMERALD study. "Our hope is that RTX001 can help prevent further clinical events in patients with decompensated cirrhosis, reducing the risk of further hospitalisations and delaying or avoiding the need for a transplant."
Dr Vijay Shah, world leading hepatologist, researcher in advanced liver disease, and Resolution Therapeutics Advisory Board Member, said, "If this treatment can help stabilise liver disease for the long term and reduce the risk of clinical events, it could be an incredible benefit for so many patients. RTX001 may give patients suffering from decompensated cirrhosis the ability to live longer and potentially improve quality of life."
Vanessa Hebditch, Director of Communications & Policy at the British Liver Trust, the UK's leading liver health charity, added: "More than three-quarters of people are diagnosed with cirrhosis when it's too late for effective treatment, contributing to more than 11,000 deaths per year in the UK. For patients and their families who currently have very limited treatment options, we are really encouraged by the progress in advancing RTX001 as a novel treatment for liver disease. We are excited to see new data from the Phase I/II EMERALD study in due course."
The Phase I/II EMERALD study builds on promising results in the academic MATCH Phase I & II studies where non-engineered RMT was well tolerated with transformational efficacy in advanced liver cirrhosis. RTX001 has been developed as a commercial product and is engineered with IL-10 and MMP-9 to enhance the anti-inflammatory and anti-fibrotic effects of RMT to therefore enable improved patient outcomes and longevity of effect in end-stage liver disease.
Additional information on the Phase I/II EMERALD study can be found on www.clinicaltrials.gov, NCT identifier NCT06823713.
Resolution Therapeutics has a pipeline of innovative programs developing RMT for additional fibrotic and inflammatory diseases with significant commercial opportunity, with an initial focus on Graft-versus-Host Disease (GvHD) and lung fibrosis.
Resolution is hosting an R&D Webinar on Wednesday 17thSeptember 2025 at 2pm BST / 9am ET / 6am PT alongside world leading clinical hepatologists Professor Jonathan Fallowfield, Chair of Translational Liver Research and Principal Investigator at the University of Edinburgh, Honorary Consultant Hepatologist at the Royal Infirmary of Edinburgh, and Dr. Elliot Tapper, MD, FAASLD, Andrews Family Research Professor of Hepatology and Associate Professor of Internal Medicine at the University of Michigan Medical School.
Please use the following link to register. A replay will be available on the News page of the Resolution Website following the event's completion.
NOTES TO EDITORS
About RTX001
RTX001 is an engineered autologous regenerative macrophage therapy with enhanced anti-fibrotic and anti-inflammatory effects. The product candidate is engineered with IL-10-MMP9 mRNA to enhance the natural regenerative properties of macrophages for superior efficacy and durability. RTX001 is being tested in the Phase I/II study called 'EMERALD', an open-label first-in-human study in end-stage liver disease measuring clinical events as the primary efficacy endpoint. The EMERALD Phase I/II study is now recruiting.
About Resolution Therapeutics
Resolution Therapeutics is a clinical-stage biopharmaceutical company focused on pioneering regenerative macrophage therapy in inflammatory and fibrotic diseases. The Company leverages its proprietary platform to develop macrophages with pro-regenerative properties for superior patient outcomes. Resolution's initial focus is on developing RTX001, its lead product with first-in-class potential supported by preclinical data demonstrating anti-fibrotic and anti-inflammatory advantages relative to non-engineered macrophages, to treat patients with end-stage liver disease. The Company is also advancing efforts to expand the potential of its platform into inflammatory and fibrotic indications beyond liver disease, including graft-vs-host disease (GVHD) and lung fibrosis. Resolution, a spinout from Professor Stuart Forbes's lab at the University of Edinburgh, is based in Edinburgh and London. Learn more by visiting https://resolution-tx.com/ and engage with us on LinkedIn.
View original content:https://www.prnewswire.co.uk/news-releases/resolution-therapeutics-announces-first-patient-dosed-in-phase-iii-emerald-study-of-rtx001-for-the-treatment-of-end-stage-liver-disease-302544026.html
