Resolution Therapeutics Gets AEMPS Approval to Expand RTX001 Phase 1/2 EMERALD Study in Spain

Resolution Therapeutics Limited (Resolution), a clinical-stage biopharmaceutical company based in Edinburgh and London, has received approval from the Spanish Agency of Medicines and Medical Products (AEMPS) to commence the Phase 1/2 EMERALD Study in Spain. This study aims to evaluate the safety and efficacy of their lead candidate, RTX001, an engineered macrophage cell therapy, in patients suffering from end-stage liver disease. The EMERALD study had already received authorization from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) and began recruiting patients in the U.K. in October 2024.

The EMERALD Study is designed as an open-label, first-in-human Phase 1/2 clinical trial. It focuses primarily on assessing the safety of RTX001 and observing key clinical events such as mortality. Additionally, the study will evaluate various biomarkers, including the Model for End-Stage Liver Disease (MELD) score, which is crucial for determining the severity of liver disease and prioritizing patients for liver transplants. The recruitment of patients in Spain is expected to begin in the second quarter of 2025.

RTX001 is a unique, autologous regenerative macrophage therapy developed with enhanced anti-fibrotic and anti-inflammatory properties. It is engineered with IL-10-MMP9 mRNA to bolster the natural regenerative capabilities of macrophages, aiming for superior efficacy and durability in treatment outcomes. The ongoing EMERALD study is the first clinical trial to test RTX001 in human patients who have recently recovered from hepatic decompensation.

Dr Clifford Brass, the Chief Medical Officer of Resolution Therapeutics, expressed enthusiasm about the AEMPS approval, stating that the expansion of the Phase 1/2 EMERALD study into Spain marks a significant milestone. The endeavor builds on the existing clinical trial authorization in the U.K., where patient recruitment is already in progress. Dr Brass emphasized that the approval signifies Resolution's commitment and momentum as they advance into 2025, aiming to develop macrophage therapies to significantly improve the outcomes for patients with inflammatory and fibrotic diseases.

The approval from AEMPS follows the presentation of promising preclinical data on RTX001 at The Liver Meeting® 2024, organized by the American Association for the Study of Liver Disease (AASLD) in San Diego. The data highlighted the superior anti-fibrotic and anti-inflammatory effects of IL-10-MMP9 engineered macrophages compared to non-engineered macrophages. These findings underscore the potential of engineered macrophages to meet significant unmet medical needs in treating end-stage liver disease.

Resolution Therapeutics is dedicated to pioneering regenerative macrophage therapies for inflammatory and fibrotic diseases. The company leverages its proprietary platform to develop macrophages with enhanced pro-regenerative properties, aiming for superior patient outcomes. RTX001 is their lead product and has demonstrated first-in-class potential, backed by preclinical data. The company is expanding its platform to address other inflammatory and fibrotic conditions beyond liver disease, such as graft-vs-host disease (GVHD) and lung fibrosis. Resolution Therapeutics originated from Professor Stuart Forbes's lab at the University of Edinburgh and operates out of Edinburgh and London.