Resolution Therapeutics has dosed the first subject and cleared for safety in its multi-centre Phase I/II EMERALD trial, assessing RTX001, an engineered regenerative macrophage therapy (RMT), for individuals with a decompensated liver cirrhosis history.
The subject was dosed at the Royal Infirmary of Edinburgh, UK. The trial is now actively recruiting participants and will be carried out at hepatology centres in Spain and the UK.
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Resolution Therapeutics aims to enrol up to 25 subjects and anticipates sharing initial clinical readouts from the trial in 2026.
The open-label, single-arm, first-in-human trial was designed to assess the efficacy and safety of the RMT.
It builds upon the encouraging outcomes of the MATCH Phase I and II academic trials, which demonstrated that non-engineered RMT was tolerated well and showed potential transformative efficacy in treating advanced liver cirrhosis.
The therapy has been refined for commercial use and is engineered to incorporate interleukin-10 (IL-10) and matrix metalloproteinase-9 (MMP-9), which are expected to improve the anti-inflammatory and anti-fibrotic properties of RMT.
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By GlobalDataResolution Therapeutics CEO Dr Amir Hefni said: “The first patient dosed represents a significant milestone in advancing RTX001 as a potential first-in-class treatment option for patients with end-stage liver disease, a condition with high mortality and severely limited therapeutic options.”
Resolution Therapeutics is not only focused on liver cirrhosis but is also developing RMT for other fibrotic and inflammatory conditions with significant commercial prospects.
Its initial targets include lung fibrosis and graft-versus-host disease (GvHD).
Last year, the company received approval from Spain’s Agency of Medicines and Medical Products (AEMPS) to extend its Phase I/II EMERALD trial of RTX001 to Spanish participants.
