Aligos Launches Phase 2a HERALD Trial for ALG-055009 in MASH Patients

Aligos Therapeutics, a biopharmaceutical firm, has commenced subject screening for its Phase 2a clinical trial of ALG-055009, a drug designed to treat metabolic dysfunction-associated steatohepatitis (MASH). The study is directed by Dr. Stephen Harrison and is set to evaluate the drug's safety and efficacy in 100 participants with presumed MASH and liver fibrosis stages 1-3. The trial, expected to begin dosing in the second quarter of 2024, will involve oral administration of one of four doses of ALG-055009 or a placebo daily for 12 weeks. Aligos believes that ALG-055009's enhanced potency and selectivity, coupled with favorable pharmacokinetics, could lead to superior therapeutic results for MASH patients.

The study will assess various non-invasive biomarkers, including MRI-PDFF, to gauge the drug's impact. Preliminary Phase 1 results indicate that ALG-055009 is well-tolerated and exhibits dose-proportional pharmacokinetics with low variability. Aligos aims to provide topline data from the HERALD study by the fourth quarter of 2024. The company, founded in 2018, is dedicated to developing leading therapies for liver and viral diseases, focusing on conditions with significant unmet medical needs, such as MASH, chronic hepatitis B, and coronaviruses.

MASH is a consequence of poor diet and lack of exercise, leading to fatty liver deposits, which affect a significant portion of the global population. The condition can lead to liver fibrosis and cirrhosis if inflammation persists. The prevalence of MASH in the U.S. is expected to rise significantly by 2030. Aligos is committed to advancing ALG-055009 as a potential best-in-class treatment for this growing patient demographic.