Resolution Therapeutics, a clinical-stage biopharmaceutical company developing regenerative macrophage therapy for inflammatory and fibrotic diseases, has announced that the first patient has been dosed in its Phase 1/2 Emerald study of RTX001. The patient has successfully cleared the safety period with no serious adverse events.

The Emerald study is evaluating RTX001, a first-in-class engineered regenerative macrophage therapy (RMT) in patients with a history of decompensated liver cirrhosis. Enrolment is now open in the UK and Spain, with an initial data readout expected in 2026.

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 1/2 Emerald study is a multi-centre, single-arm, 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. Up to 25 patients will be enrolled, with the first dosed at the Royal Infirmary of Edinburgh.

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, 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. 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, hepatologist, researcher in advanced liver disease, and Resolution Therapeutics advisory board member, added: “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 and policy at the British Liver Trust, said: “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 1/2 Emerald study in due course.”

The Emerald study builds on earlier Match Phase 1 and 2 studies, where non-engineered RMT was well tolerated and showed signs of efficacy in advanced liver cirrhosis. RTX001 has been engineered with IL-10 and MMP-9 to enhance anti-inflammatory and anti-fibrotic effects, aiming to improve patient outcomes and durability of response in end-stage liver disease.