Resolution Therapeutics completes enrolment in EMERALD liver trial
Resolution Therapeutics has completed enrolment in EMERALD, its Phase I/II clinical trial evaluating RTX001 in patients with end-stage liver disease (ESLD) who have a history of decompensated liver cirrhosis. All 15 patients have now been dosed, and the London and Edinburgh-based company expects to release interim data in the fourth quarter of 2026.
RTX001 is an engineered Regenerative Macrophage Therapy (RMT) designed to address both inflammation and fibrosis simultaneously. The candidate is engineered with IL-10 and MMP-9 to enhance its anti-inflammatory and anti-fibrotic properties. Notably, it is administered via a peripheral intravenous infusion lasting fewer than 10 minutes, requiring no pre-conditioning, bridging therapy, or lymphodepletion. Resolution says the manufacturing process was designed from the outset with commercial-scale production in mind and that ongoing refinements have reduced cost-of-goods by 40% to date.
The clinical case
ESLD represents a significant unmet medical need. Liver transplantation remains the only established disease-modifying intervention, yet it is severely constrained by donor availability, access to specialist centres, and the cost and complexity of surgery. Resolution cites a US patient population of more than 500,000, projected to reach 600,000 by 2040. The prognosis following decompensation is stark: the company reports that 37% of patients die and only 5% receive a transplant within two years of their first decompensation event, while median survival falls to nine months after a second event.
Chief executive Amir Hefni said the completion of dosing "marks a significant milestone for Resolution Therapeutics and reflects our progress toward a potential new treatment paradigm for end-stage liver disease." The company is positioning RTX001 as a potential first-in-class therapy, though that characterisation rests on preclinical data and will require clinical validation. Interim readouts from EMERALD will be the first test of whether the efficacy signals observed in the laboratory translate in patients.
Regulatory path and competitive landscape
Resolution has already held a pre-IND meeting with the FDA and plans to initiate a US pivotal study in 2027, with site selection to be finalised after the pivotal design is agreed. The EMERALD study itself is being conducted across multiple hepatology centres in the UK and Spain.
The macrophage therapy field is relatively uncrowded compared with other cell-based modalities such as CAR-T, but it sits within a broader wave of interest in cell therapies for fibrotic and inflammatory disease. Academic spinouts and early-stage biotechs are exploring macrophage-based approaches across liver, lung, and kidney indications, and Resolution is one of the few to reach first-in-human testing in ESLD specifically. The company is also advancing a preclinical RMT programme in lung fibrosis and developing an in vivo RMT platform, giving it potential optionality beyond the liver.
The Q4 2026 interim data release will be closely watched. Safety and tolerability data from the full 15-patient cohort will be the primary focus at this stage; any early signals on liver function or fibrosis markers would carry significant weight for the company's fundraising position and its ability to attract a US clinical partner ahead of the planned pivotal study.