Biopharmaceutical spinout Resolution Therapeutics has announced the first patient has been dosed and safety cleared in the Phase I/II EMERALD study of its novel therapy for end-stage liver disease.
EMERALD is evaluating RTX001, a regenerative macrophage therapy (RMT) to treat inflammatory and fibrotic diseases, developed from work by Professor Stuart Forbes of the University of Edinburgh’s Institute for Regeneration and Repair, who co-founded Resolution in 2020.
Following this early trial success, with the first patient dosed at the Royal Infirmary of Edinrbugh, 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 liver cirrhosis.
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, Chair of Translational Liver Research 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. ”
Lizzie Withington, Director of Venture Creation at Edinburgh Innovations (EI), said:
This is a huge milestone in the journey of a potential treatment from lab to clinic. EI is proud to support Professors Forbes and Fallowfield and the Resolution team as they continue to offer hope to patients and their families who currently have very limited treatment options. ”
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.
Resolution is hosting an R&D Webinar on Wednesday 17th September 2025 at 2pm BST / 9am ET / 6am PT alongside Professor Fallowfield 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.
