Aligos Therapeutics Announces Positive Topline Results from the Phase 2a HERALD Study of ALG-055009 for the Treatment of MASH
- ALG-055009 dose groups met the primary endpoint with statistically significant reductions in liver fat at Week 12 as measured by MRI-PDFF
- Placebo-adjusted median relative reductions in liver fat were up to 46.2% with a clear dose response
- ALG-055009 was well-tolerated with no serious adverse events or dose reductions. Importantly, ALG-055009 dose groups had a similar incidence of gastrointestinal-related adverse events with less diarrhea compared to placebo
- Significant reductions in atherogenic lipids, including LDL-C, lipoprotein (a), and apolipoprotein B were observed
- Conference call scheduled for 8:30am ET/5:30am PT today
Excerpt from the Press Release:
SOUTH SAN FRANCISCO, Calif., Sept. 19, 2024 (GLOBE NEWSWIRE) — Aligos Therapeutics, Inc. (Nasdaq: ALGS) a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today announced positive topline results from the Phase 2a HERALD study of ALG-055009, a thyroid hormone receptor beta (THR-β) agonist, in metabolic-dysfunction associated steatohepatitis (MASH) subjects.
HERALD (NCT06342947) is a randomized, double-blind, placebo-controlled trial that enrolled 102 subjects with presumed MASH and stage 1-3 liver fibrosis (F1-F3). Subjects were 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 for 12 weeks. Only subjects weighing >85 kg were enrolled in the 0.9 mg dose group, with no body weight restrictions implemented in the other dose groups. Key endpoints assessed were safety, tolerability, pharmacokinetics, relative change in liver fat content by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF), and other non-invasive biomarkers/tests.
Doses of 0.5 mg to 0.9 mg ALG-055009 demonstrated statistically significant reductions in liver fat at Week 12, with placebo-adjusted median relative reductions up to 46.2% as measured by MRI-PDFF. Up to 70% of subjects achieved ≥30% relative reduction in liver fat compared to baseline.
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