Resolution Therapeutics, a clinical-stage biopharmaceutical company pioneering Regenerative Macrophage Therapy (RMT) for inflammatory and fibrotic diseases, announced that the first patient has been successfully dosed and cleared for safety in its Phase I/II Emerald study of RTX001. Following this milestone, the trial is now open for full enrolment in the UK and Spain.

As the first engineered RMT to enter human testing, RTX001 represents a groundbreaking advance in the treatment of end-stage liver disease, offering new hope for patients with limited options.

Dr. Amir Hefni, Chief Executive Officer of Resolution Therapeutics, commented: “Dosing the first patient in the Emerald study marks a pivotal step forward in advancing RTX001 as a potential first-in-class therapy for end-stage liver disease, a devastating condition with few treatment options. We are eager to build on this momentum and look forward to sharing our first clinical readouts in 2026.”

The Emerald study is a multi-centre, single-arm, open-label Phase I/II trial designed to evaluate the safety and efficacy of RTX001 in patients who have recovered from recent hepatic decompensation. Conducted at leading hepatology centres across the UK and Spain, the study will enrol up to 25 patients, with the first dose administered at the Royal Infirmary of Edinburgh.

Professor Jonathan Fallowfield, Chief Investigator of the Emerlad study, Chair of Translational Liver Research at the University of Edinburgh, and Honorary Consultant Hepatologist at the Royal Infirmary of Edinburgh, said: “Most hospitalisations and deaths from liver disease result from decompensated cirrhosis, for which no approved therapies exist. Transplantation remains the only option, but it is limited by donor availability and patient eligibility. RTX001 has the potential to stabilise disease at this critical stage, reduce hospitalisations, and delay or even prevent the need for transplantation.”

Dr. Vijay Shah, world-leading hepatologist and member of Resolution’s Advisory Board, added: “If RTX001 can deliver long-term disease stability and lower the risk of serious clinical events, it could dramatically improve both survival and quality of life for patients living with decompensated cirrhosis.”

Vanessa Hebditch, Director of Communications & Policy at the British Liver Trust, commented: “More than three-quarters of people are diagnosed with cirrhosis too late for effective treatment, contributing to over 11,000 deaths annually in the UK. For patients and families facing such limited options, the progress of RTX001 represents an exciting and much-needed breakthrough. We look forward to seeing the results of the Emerald study.”