Aligos Therapeutics announced positive topline results from its Phase 2a HERALD study of ALG-055009 for metabolic-dysfunction associated steatohepatitis (MASH). Doses of 0.5 mg to 0.9 mg of ALG-055009 demonstrated statistically significant reductions in liver fat at Week 12. Placebo-adjusted median relative reductions reached up to 46.2% as measured by MRI-PDFF.
Up to 70% of subjects in the study achieved a 30% or greater relative reduction in liver fat compared to baseline. The study also showed significant reductions in atherogenic lipids, including LDL-C, lipoprotein (a), and apolipoprotein B. These lipid reductions suggest potential cardiovascular benefits in addition to liver fat reduction.
ALG-055009 demonstrated a favorable tolerability profile, with no serious adverse events or clinical hyper/hypothyroidism reported. The company is now evaluating options, including potential out-licensing, to fund the continued development of this program. Aligos plans to complete activities required for a Phase 2b study by mid-2025.
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