Resolution Therapeutics has announced that the Spanish Agency of Medicines and Medical Products (AEMPS) has approved its Clinical Trial Application (CTA) to extend the Phase 1/2 EMERALD study of RTX001 to Spain. This trial aims to assess the safety and efficacy of RTX001, an innovative engineered macrophage cell therapy, in patients suffering from end-stage liver disease.
The EMERALD study is an open-label, first-in-human Phase 1/2 trial. It will primarily focus on evaluating the safety profile of RTX001 and monitoring major clinical events, including mortality. The trial will also assess key biomarkers, such as the Model for End-Stage Liver Disease (MELD) score, a critical tool for evaluating disease severity and prioritizing patients for liver transplantation.
"We are excited to have received approval from the AEMPS to expand our Phase 1/2 EMERALD study for RTX001 into Spain," said Dr. Clifford Brass, Chief Medical Officer of Resolution Therapeutics. "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."
RTX001: Engineered Macrophage Therapy
RTX001 is an autologous regenerative macrophage therapy engineered to enhance its anti-fibrotic and anti-inflammatory properties. The therapy involves modifying macrophages with IL-10-MMP9 mRNA to amplify their natural regenerative capabilities, potentially leading to improved efficacy and durability in treating liver disease.
The AEMPS approval follows the presentation of preclinical data on RTX001 at The Liver Meeting® 2024, demonstrating the superior anti-fibrotic and anti-inflammatory effect of IL-10-MMP9 engineered macrophages over non-engineered macrophages.
EMERALD Study Details
The EMERALD study is currently recruiting patients in the U.K. since October 2024, following initial authorization from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA). The expansion into Spain is anticipated to begin in the second quarter of 2025. The study targets patients with end-stage liver disease who have recently experienced hepatic decompensation.
