Resolution Therapeutics completes enrollment in Phase I/II EMERALD clinical trial evaluating RTX001 in end-stage liver disease

• 15 patients dosed with RTX001, an engineered Regenerative Macrophage Therapy designed to address inflammation and fibrosis
• EMERALD is evaluating safety and efficacy of RTX001 in patients with end-stage liver disease and a history of decompensated liver cirrhosis
• Interim clinical data expected in Q4 2026
  
  

LONDON and EDINBURGH, United Kingdom, Sept. 11, 2026 (GLOBE NEWSWIRE) -- Resolution Therapeutics Limited (“Resolution” or “Company”), a clinical-stage biopharmaceutical company pioneering Regenerative Macrophage Therapy (RMT) in inflammatory and fibrotic diseases, today announced that the final patient has been treated in EMERALD, the Company’s Phase I/II clinical trial evaluating its engineered RMT, RTX001, in patients with end-stage liver disease (ESLD) and a history of decompensated liver cirrhosis. Interim data are expected in the fourth quarter of 2026.

Liver transplantation remains the only disease-modifying treatment Option for patients with ESLD. Transplantation, however, is severely constrained by limited access to transplant centers, donor availability, and the complexity and cost of surgery, leaving many patients with no Option beyond symptom management.

Amir Hefni, Chief Executive Officer of Resolution Therapeutics, said: “Dosing the final patient in the EMERALD trial marks a significant milestone for Resolution Therapeutics and reflects our progress toward a potential new treatment paradigm for end-stage liver disease. Patients with this condition face very limited options beyond transplantation and symptom management, and RTX001 has the potential to offer a differentiated, transformational therapeutic approach. We are working with urgency to advance the clinical program and bring this therapy closer to the patients who need it.”

EMERALD is a multi-center, single-arm, first-in-human, open-label study evaluating the safety and efficacy of RTX001 in patients with end-stage liver disease who have recovered from a recent hepatic decompensation. The study is being conducted at leading hepatology centers across the UK and Spain.

RTX001 is engineered with IL-10 and MMP-9 to enhance the anti-inflammatory and anti-fibrotic effects of RMT, with the aim of improving patient outcomes and durability of response in end-stage liver disease. RTX001 is administered via peripheral IV requiring no pre-conditioning, bridging therapy, or lymphodepletion; the outpatient infusion takes less than 10 minutes. The manufacturing process was developed with commercial-scale production in mind, and ongoing process refinements have reduced cost-of-goods by 40% to date. In pre-clinical studies, RTX001 has demonstrated no significant safety signals and did not require prolonged monitoring.

Resolution plans to initiate a pivotal study for RTX001 in patients with end-stage liver disease across the U.S. in 2027, following a pre-IND meeting between Resolution and the FDA. Subsequently, the Company will finalize the pivotal study design and specific clinical trial site selection.

Beyond RTX001, Resolution is advancing additional RMT programs in inflammatory and fibrotic diseases, including lung fibrosis, while continuing development of its in vivo RMT. These programs are in preclinical evaluation.

For further information, please contact:

Company
Louise Rowe
Vice President, Operations
contact@resolution-tx.com

Media
Optimum Strategic Communications
Stephen Adams, Joshua Evans, Aoife Minihan
resolution@optimumcomms.com
+44 (0) 20 3821 6420

NOTES TO EDITORS

About ESLD

The end stage liver disease (ESLD) patient population in U.S. is more than 500,000 and expected to grow to 600,000 by 2040. Patients face high mortality rates and limited transplant-free survival. Following a patient’s first decompensation, disease progresses rapidly towards death (37%) or liver transplant (5%) within two years. Furthermore, median survival drops from two years after first decompensation to nine months after the second decompensation event.

About Regenerative Macrophage Therapy (RMT)

Resolution is pioneering a differentiated scientific approach focused on resolving inflammation and fibrosis at the microenvironment level. The therapeutic strategy aims to restore macrophages so they can restart the body’s natural repair process.

Macrophages have a dual anti-inflammatory and anti-fibrotic effect. By addressing both inflammation and fibrosis, Regenerative Macrophage Therapy is designed to enable tissue regeneration rather than targeting a single disease pathway. Its multimodal mechanism acts on the disease microenvironment, creating potential across a broad range of chronic inflammatory and fibrotic diseases.

About Resolution Therapeutics

Resolution Therapeutics is a clinical-stage biopharmaceutical company focused on pioneering Regenerative Macrophage Therapy in inflammatory and fibrotic diseases. The Company leverages its proprietary platform to develop macrophages with pro-regenerative properties for superior patient outcomes. Resolution’s initial focus is on developing RTX001, its lead product with first-in-class potential supported by preclinical data demonstrating anti-fibrotic and anti-inflammatory advantages relative to non-engineered macrophages, to treat patients with end-stage liver disease. The Company is also advancing efforts to expand the potential of its platform into inflammatory and fibrotic indications beyond liver disease, including lung fibrosis. Resolution, a spinout from Professor Stuart Forbes’s lab at the University of Edinburgh, is based in Edinburgh and London. Learn more by visiting https://resolution-tx.com/ and engage with us on LinkedIn.