Aligos Therapeutics, Inc. announced that dosing in the Phase 2a HERALD study of ALG-055009 has been initiated in subjects with metabolic dysfunction-associated steatohepatitis (MASH). HERALD (NCT06342947) is a randomized, placebo-controlled trial that will enroll 100 subjects with presumed MASH and stage 1-3 liver fibrosis (F1-F3). Subjects will be randomized to receive one of four doses (0.3, 0.5, 0.7, 0.9 mg) of ALG-05500 9 or placebo (20 subjects/arm) given orally once daily for 12 weeks.

In addition to collecting safety and pharmacokinetic (PK) data, this study will also assess multiple non-invasive biomarkers, which include Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) and other tests previously shown to be impacted by treatment with thyroid hormone receptor beta (THR-ß) agonists. Topline safety and efficacy data from this study are expected in fourth quarter 2024.