Resolution Therapeutics has secured approval from the Spanish Agency of Medicines and Medical Products (AEMPS) to extend its Phase I/II EMERALD study of RTX001 into Spain. This open-label, first-in-human trial aims to evaluate the safety and efficacy of RTX001, a regenerative macrophage therapy, in patients with end-stage liver disease.
EMERALD Study Details
The EMERALD study's primary endpoints are centered on safety and the incidence of 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 crucial for assessing disease severity and prioritizing patients for liver transplantation. The trial is already underway in the UK, with the first patients recruited in October.
RTX001: A Novel Macrophage Therapy
RTX001, Resolution Therapeutics' lead product, is an engineered, autologous regenerative macrophage therapy. It is designed for patients with end-stage liver disease. The therapy leverages the anti-fibrotic and anti-inflammatory effects of IL-10-MMP9 engineered macrophages, which, according to research presented at The Liver Meeting 2024, have shown superior effects compared to non-engineered macrophages.
Company Perspective
Clifford Brass, chief medical officer of Resolution Therapeutics, stated, "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 UK, where patient recruitment is underway, 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."
Context of Liver Disease Treatment
The expansion of the RTX001 trial comes amid ongoing efforts to improve treatments for liver diseases. For instance, Novo Nordisk has reported positive outcomes from part one of the ESSENCE trial of semaglutide 2.4mg in treating metabolic dysfunction-associated steatohepatitis (MASH) alongside moderate to advanced liver fibrosis, highlighting the continued need for innovative therapies in this area.
