Scottish biopharmaceutical company Resolution Therapeutics has received approval from Spain’s Agency of Medicines and Medical Products (AEMPS) to expand its Phase I/II EMERALD study of RTX001, a regenerative macrophage therapy, into Spain.
RTX001 is Edinburgh-based Resolution’s lead product. It is described as an engineered, autologous regenerative macrophage therapy for patients living with end-stage liver disease.
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The approval of the open-label, first-in-human trial in Spain marks the second country for the early stages of the trial after Resolutionpreviously secured its first clinical trial authorisation from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) earlier this year with the first patients recruited in October.
The company’s EMERALD study will seek to investigate the safety and efficacy of RTX001 in patients with end-stage liver disease, with primary endpoints centered on safety and major clinical events, including death. It will also look to 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.
Clifford Brass, chief medical officer of Resolution Therapeutics, said: “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.”
The announcement comes after a presentation before the American Association for the Study of Liver Disease (AASLD) The Liver Meeting 2024. Held in San Diego in November,research presented by the company found that its therapy system showed superior anti-fibrotic and anti-inflammatory effects of IL-10-MMP9 engineered macrophages over non-engineered macrophages.
Elsewhere in the treatment of liver diseases, 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.
