Aligos Therapeutics Announces First Subjects Dosed in the Phase 2a HERALD Study of ALG-055009 in MASH Subjects

SOUTH SAN FRANCISCO, Calif., April 03, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced that dosing in the Phase 2a HERALD study of ALG-055009 has been initiated in subjects with metabolic dysfunction-associated steatohepatitis (MASH).

“Dosing the first subjects in our Phase 2a HERALD study is an important milestone for Aligos,” said Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer at Aligos Therapeutics. “We are pleased by the engagement of the clinicians and subjects, demonstrating the need for additional oral MASH therapies. We look forward to continuing to advance this potent, potential best-in-class drug candidate through the clinic.”

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-055009 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 Q4 2024.

About ALG-055009
ALG-055009 appears to be a best-in-class thyroid hormone receptor beta (THR-ß) agonist discovered by Aligos for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). ALG-055009 recently completed a Phase 1 first in human study, with preliminary data after single and multiple daily doses showing that ALG-055009 was well tolerated, had dose proportional pharmacokinetics (PK) and low variability, and demonstrated expected thyromimetic effects. Aligos has begun dosing in the Phase 2a HERALD study of ALG-055009 to assess safety, PK, and multiple efficacy biomarkers such as Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF). Topline safety and efficacy data from this study are expected in Q4 2024.