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

• Screening of subjects has begun at clinical study sites
  
• The Phase 2a study is being led by Principal Investigator, Dr. Stephen Harrison
• Aligos anticipates dosing the first subject in Q2 2024 with topline safety and efficacy data expected in Q4 2024
  

SOUTH SAN FRANCISCO, Calif., March 18, 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 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.

“ALG-055009 has enhanced potency, greater beta selectivity, and a favorable PK profile. We believe that these optimized pharmacologic properties may result in improved therapeutic outcomes for patients living with MASH. The initiation of the HERALD study is an important next step in achieving our goal to create a best-in-class thyroid hormone receptor beta agonist,” stated Lawrence Blatt, Ph.D., MBA, Chairman, President, and CEO of Aligos Therapeutics. “This is an exciting time in the MASH space with the first drug recently approved, but we believe there is still a need for additional treatment options. We look forward to sharing topline HERALD data in Q4 this year.”

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 Q2 2024 and topline safety and efficacy data from this study is 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 initiated 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). Dosing is anticipated to begin in Q2 2024 and topline safety and efficacy data from this study is expected in Q4 2024.