Resolution Therapeutics has announced the approval of its clinical trial application by the Spanish Agency of Medicines and Medical Products (AEMPS) to expand the Phase 1/2 EMERALD study of RTX001 into Spain. This open-label, first-in-human study will assess the safety and efficacy of RTX001 in patients with end-stage liver disease, building on the ongoing recruitment in the UK following MHRA approval earlier in 2024. The expansion aims to further evaluate the potential of engineered macrophage therapy in addressing significant unmet needs in advanced liver disease.
EMERALD Study Design and Objectives
The EMERALD study is designed to evaluate RTX001 in patients who have recovered from a recent hepatic decompensation. The primary focus of the study is to assess the safety profile of RTX001 and monitor major clinical events, including death. Secondary endpoints include the evaluation of biomarkers, such as the Model for End-Stage Liver Disease (MELD) score, which is used to assess disease severity and prioritize patients for liver transplantation. The study began recruiting patients in the UK in October 2024 and anticipates starting recruitment in Spain in the second quarter of 2025.
RTX001: Engineered Macrophage Therapy
RTX001 is an engineered, autologous regenerative macrophage therapy designed to enhance anti-fibrotic and anti-inflammatory effects. The therapy is engineered with IL-10-MMP9 mRNA to augment the natural regenerative properties of macrophages, potentially offering superior efficacy and durability compared to non-engineered macrophages. Preclinical data presented at The Liver Meeting® 2024 demonstrated the superior anti-fibrotic and anti-inflammatory effects of IL-10-MMP9 engineered macrophages.
Resolution Therapeutics' Vision
Dr. Clifford Brass, Chief Medical Officer of Resolution Therapeutics, expressed enthusiasm about the AEMPS approval, stating, "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."
Resolution Therapeutics is focused on pioneering regenerative macrophage therapy for inflammatory and fibrotic diseases. The company's platform aims to develop macrophages with pro-regenerative properties to improve patient outcomes. Beyond liver disease, Resolution is also exploring applications of its platform in other inflammatory and fibrotic indications, including graft-vs-host disease (GVHD) and lung fibrosis.
