EDINBURGH and LONDON, UK — September 11, 2026
Resolution Therapeutics Limited announced that the final patient has been treated in the Phase I/II EMERALD clinical trial evaluating RTX001, an engineered Regenerative Macrophage Therapy (RMT) for patients with end-stage liver disease (ESLD) and a history of decompensated liver cirrhosis. A total of 15 patients have been dosed in the first-in-human study, with interim clinical data expected in Q4 2026. EMERALD is a multicenter, single-arm, open-label study designed to evaluate the safety and efficacy of RTX001 in patients who have recovered from a recent hepatic decompensation. The trial is being conducted at leading hepatology centers across the UK and Spain, marking an important clinical development milestone for Resolution as it evaluates a potential therapeutic approach for a population with limited disease-modifying options beyond liver transplantation.
RTX001 Targets Inflammation and Liver Fibrosis
RTX001 is engineered to enhance the anti-inflammatory and anti-fibrotic activity of regenerative macrophages through the incorporation of IL-10 and MMP-9. The therapy is designed to address two key biological drivers of advanced liver disease: persistent inflammation and fibrosis. Unlike conventional cell therapies that may require intensive preparative treatment, RTX001 is administered through a peripheral intravenous infusion without pre-conditioning, bridging therapy or lymphodepletion. The outpatient infusion takes less than 10 minutes, potentially simplifying treatment delivery for patients with advanced disease. Resolution said preclinical studies have shown no significant safety signals and no requirement for prolonged monitoring. The company has also developed the manufacturing process with commercial-scale production in mind, reporting a 40% reduction in cost of goods to date through ongoing process improvements. These manufacturing and administration characteristics are central to Resolution’s strategy for developing RMT as a potentially scalable treatment platform.
EMERALD Data to Guide Pivotal Development
The completion of patient dosing positions Resolution Therapeutics to generate the next clinical evidence for RTX001 in end-stage liver disease. The company expects interim EMERALD data in the fourth quarter of 2026, with safety and efficacy findings expected to inform subsequent regulatory and clinical development decisions. Liver transplantation remains the only disease-modifying treatment option for ESLD, but access is constrained by donor availability, transplant-center capacity and the complexity and cost of surgery. Resolution is therefore pursuing RTX001 as a potential alternative therapeutic strategy for patients who have limited options beyond transplantation and symptom management. Following a planned pre-IND meeting with the U.S. FDA, the company intends to initiate a pivotal RTX001 study in the United States in 2027. Resolution expects to finalize the pivotal study design and clinical-site selection following regulatory discussions, making the upcoming EMERALD readout an important milestone for the program.
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Resolution Expands Regenerative Macrophage Platform
RTX001 is the lead clinical program within Resolution Therapeutics’ broader Regenerative Macrophage Therapy platform, which the company is developing for inflammatory and fibrotic diseases. Beyond end-stage liver disease, Resolution is advancing additional RMT programs targeting conditions including lung fibrosis, while also developing an in vivo RMT approach. These programs remain in preclinical development as the company focuses on advancing RTX001 through clinical evaluation. The EMERALD enrollment milestone strengthens the company’s transition toward late-stage development and provides an opportunity to demonstrate whether engineered regenerative macrophages can deliver durable biological and clinical benefits in advanced fibrotic disease. With 15 patients treated, interim data expected in Q4 2026 and a U.S. pivotal study planned for 2027, Resolution Therapeutics is positioning RTX001 as the foundation of a potentially differentiated regenerative medicine strategy for end-stage liver disease.
Source: Crossbow Therapeutics press release
