Resolution Therapeutics has announced that the first patient has been dosed and safety cleared in its phase 1/2 EMERALD study of RTX001, a first-in-class engineered regenerative macrophage therapy (RMT) for end-stage liver disease. The study is now open for enrolment in the UK and Spain.
RTX001 is the first engineered RMT to be evaluated in humans with advanced liver fibrosis. The EMERALD study is a multi-centre, single-arm, open-label trial assessing safety and efficacy in patients who have recovered from hepatic decompensation. Up to 25 patients will be enrolled, with the first dosed at the Royal Infirmary of Edinburgh.
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.”
Professor Jonathan Fallowfield, Chief Investigator of the EMERALD study, said: “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.”
Dr Vijay Shah, Advisory Board Member at Resolution Therapeutics, said: “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, added: “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 1/2 EMERALD study in due course.”
