Phase 2a HERALD Study Initiates Dosing of ALG-055009 for MASH

3 June 2024
Aligos Therapeutics, a clinical-stage biopharmaceutical firm, has commenced dosing for its Phase 2a HERALD study. This study focuses on ALG-055009, a potential treatment for metabolic dysfunction-associated steatohepatitis (MASH), a liver condition linked to poor diet and lack of exercise. The trial will include approximately 100 participants with presumed MASH and mild to moderate liver fibrosis. They will be assigned to receive one of four dosages of ALG-055009 or a placebo over a 12-week period.

The HERALD study is designed to evaluate the safety and pharmacokinetics of ALG-055009, along with several non-invasive biomarkers, including MRI-PDFF, which measures liver fat content. ALG-055009 has completed a Phase 1 trial, showing promising results in terms of tolerability and pharmacokinetics. The company anticipates releasing preliminary safety and efficacy data by the end of 2024.

MASH is a prevalent condition, with an estimated 30% of the global population affected by the accumulation of fatty liver deposits. The prevalence of MASH in the U.S. is expected to rise from 16.5 million in 2015 to 27 million by 2030. If left untreated, MASH can lead to liver fibrosis, cirrhosis, and other serious health complications.

Founded in 2018, Aligos Therapeutics aims to lead in the treatment of liver and viral diseases. The company is dedicated to leveraging its expertise to develop innovative therapies for MASH and other high-need conditions such as hepatitis B and coronaviruses. ALG-055009 is seen as a candidate for a best-in-class THR-ß agonist, which has recently gained approval for treating MASH.

Aligos Therapeutics is committed to advancing ALG-055009 through clinical trials and is hopeful for its potential as a leading drug in treating MASH. The company's mission is to address significant unmet medical needs in the areas of liver and viral diseases, drawing on its team's extensive experience in drug development.

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