IRR spinout Resolution Therapeutics doses first patient in clinical trial

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, invented by Professor Stuart Forbes of the 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 Edinburgh, 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.

Macrophages are immune cells which act as clean-up cells in the body, eating bacteria and damaged cells. RMT works by taking macrophages out of a patient's body, engineering the macrophages to recognise damaged cells, in this case liver cirrhosis cells, and re-inserting them back into the patient. The engineered macrophages then seek out the damaged liver cells, removing them and promoting regeneration of healthy cells. 

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.

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.

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.

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