Resolution Therapeutics Announces Approval of Clinical Trial Application by AEMPS to Expand Phase 1/2 EMERALD Study of RTX001 into Spain

-  EMERALD Study will investigate the safety and efficacy of RTX001, an engineered macrophage cell therapy, in patients with end-stage liver disease

-  Recruitment already underway in the U.K., following recent MHRA approval

EDINBURGH, Scotland and LONDON, Nov. 19, 2024 /PRNewswire/ -- Resolution Therapeutics Limited ("Resolution"), a clinical-stage biopharmaceutical company pioneering regenerative macrophage therapies in inflammatory and fibrotic diseases, today announces it has received approval of a clinical trial application from the Spanish Agency of Medicines and Medical Products (AEMPS) to commence the Phase 1/2 EMERALD Study evaluating its lead candidate RTX001 in Spain.

EMERALD is an open-label, first-in-human Phase 1/2 study which will investigate the safety and efficacy of RTX001 in patients with end-stage liver disease. The primary analysis will focus on safety and major clinical events, including death. The study will also evaluate biomarkers, such as the Model for End-Stage Liver Disease (MELD) score, which is used to assess disease severity and prioritise patients for a liver transplant.

The EMERALD study received its first clinical trial authorisation from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) earlier this year, and started recruiting patients in October 2024 in the U.K. It is expected to start recruiting patients in Spain in the second quarter of 2025.

Dr Clifford Brass, Chief Medical Officer of Resolution Therapeutics, commented: "We are excited to have received approval from the AEMPS to expand our Phase 1/2 EMERALD study for RTX001 into Spain. This builds on the existing clinical trial authorisation in the U.K, where patient recruitment is under way, and further demonstrates the momentum Resolution looks to carry into 2025, as we  deliver on our mission of developing macrophage therapies to transform the outcomes of patients with inflammatory and fibrotic diseases."

The AEMPS approval follows the presentation of preclinical data on RTX001 at the American Association for the Study of Liver Disease (AASLD) The Liver Meeting® 2024, held in San Diego from 15-19 November 2024, demonstrating the superior anti-fibrotic and anti-inflammatory effect of IL-10-MMP9 engineered macrophages over non-engineered macrophages. Together, these data underscore the potential of engineered macrophages to address high unmet medical needs in end-stage liver disease.

About RTX001 

RTX001 is an engineered, autologous regenerative macrophage therapy with enhanced anti-fibrotic and anti-inflammatory effect. The product candidate is engineered with IL-10-MMP9 mRNA to enhance the natural regenerative properties of macrophages for superior efficacy and durability. RTX001 is being evaluated in the ongoing Phase 1/2 EMERALD study.

About EMERALD

EMERALD is a first-in-human, open-label Phase 1/2 interventional study assessing the safety and efficacy of RTX001 in patients with end-stage liver disease who have recovered from a recent hepatic decompensation. It is conducted in the UK and Spain and began recruiting patients in October 2024. For more information, please visit https://resolution-tx.com/patients/.

About Resolution Therapeutics

Resolution Therapeutics is a clinical-stage biopharmaceutical company 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 its platform into inflammatory and fibrotic indications beyond liver disease, including graft-vs-host disease (GVHD) and 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.