Resolution Therapeutics Doses First Patient in Landmark Cell Therapy Trial for Liver Disease

EDINBURGH, Scotland and LONDON, UK — Sep 03, 2025,— Resolution Therapeutics, a clinical-stage biopharmaceutical company, announced today that the first patient has been dosed with its engineered regenerative macrophage therapy, RTX001, in the Phase I/II EMERALD study. Following the successful and safe administration, the study is now open for full enrollment in the UK and Spain.

This marks the first time an engineered regenerative macrophage therapy has been administered to a patient with end-stage liver disease, representing a significant breakthrough in the development of this novel treatment.

“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,” said Dr. Amir Hefni, CEO of Resolution Therapeutics. “This is 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.”

A Novel Approach to End-Stage Liver Disease

The single-arm, open-label EMERALD study aims to evaluate the safety and efficacy of RTX001 in up to 25 patients who have recently recovered from a hepatic decompensation event. The trial is being conducted at leading hepatology centers, including the Royal Infirmary of Edinburgh, where the first patient was dosed.

Liver transplantation is currently the only effective treatment for decompensated cirrhosis, but it’s limited by donor availability and suitability for a small subset of patients.

Professor Jonathan Fallowfield, the study’s Chief Investigator, highlighted this unmet need, stating, “Most liver-related hospitalizations and deaths result from decompensated cirrhosis, yet there are no licensed therapies that stabilize or reverse the disease at this late stage.” He added, “Our hope is that RTX001 can help prevent further clinical events… reducing the risk of further hospitalizations and delaying or avoiding the need for a transplant.”

The therapy is an advancement of a non-engineered version, which showed promising results in earlier academic studies. RTX001 is engineered with IL-10 and MMP-9 mRNA to enhance its natural anti-inflammatory and anti-fibrotic effects, aiming for improved and longer-lasting patient outcomes.

Resolution Therapeutics will host an R&D webinar on September 17, 2025, to provide more information on the study.