Aligos Therapeutics, Inc. announced the initiation of the Phase 2a HERALD study of ALG-055009 in subjects with metabolic dysfunction-associated steatohepatitis (MASH). Screening of subjects has begun at clinical study sites across the U.S. The 12-week randomized, placebo-controlled trial will enroll 100 subjects with presumed MASH and liver fibrosis at stages 1-3 (F1-F3). Subjects will be randomized to receive one of four doses (0.3, 0.5, 0.7, 0.9 mg) of ALG-055009 or placebo (~20 subjects/arm) given orally once daily.

In addition to collecting safety and pharmacokinetics (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. Dosing is anticipated to begin in second quarter 2024 and topline safety and efficacy data from this study is expected in fourth quarter 2024.