Resolution Therapeutics, a UK-based clinical-stage biopharmaceutical company involved in Regenerative Macrophage Therapy (RMT) to treat inflammatory and fibrotic diseases, announced on Wednesday that the first patient has been dosed and safety cleared in its Phase I/II EMERALD study.

EMERALD will evaluate RTX001, a first-in-class engineered RMT for patients with a history of decompensated liver cirrhosis. 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, Resolution Therapeutics' CEO, 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 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.

Resolution says that 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 thereby enable improved patient outcomes and longevity of effect in end-stage liver disease.