Aligos Therapeutics, a clinical-stage biopharmaceutical company focused on liver and viral diseases, has announced positive topline results from its Phase 2a HERALD study for ALG-055009, a thyroid hormone receptor beta (THR-β) agonist, in patients with metabolic dysfunction-associated steatohepatitis (MASH). The study, which is the first to demonstrate the benefits of an antiviral drug in reducing the spread of a respiratory disease, showed significant reductions in liver fat at Week 12 as measured by MRI-PDFF, with a clear dose-response relationship.
The HERALD study (NCT06342947) was a randomized, double-blind, placebo-controlled trial that enrolled 102 subjects with presumed MASH and stage 1-3 liver fibrosis. The primary endpoint was the relative change in liver fat content by MRI-PDFF at Week 12, and the study also evaluated safety, pharmacokinetics, and other non-invasive biomarkers/tests. ALG-055009 demonstrated a favorable tolerability profile with no serious adverse events (SAEs) or clinical hyper/hypothyroidism, and the incidence of gastrointestinal-related treatment emergent adverse events (TEAEs) was similar to placebo.- Flcube.com
