Aligos Completes Enrollment for ALG-055009 Phase 2a HERALD MASH Study

Aligos Therapeutics, Inc., a clinical stage biopharmaceutical company based in South San Francisco, recently announced the completion of enrollment for its Phase 2a HERALD study. This trial investigates ALG-055009, a potential treatment for metabolic dysfunction-associated steatohepatitis (MASH). The company expects the topline safety and efficacy data to be available in early Q4 2024. Dr. Rohit Loomba will serve as the Principal Investigator for the study.

Dr. Lawrence Blatt, Chairman, President, and CEO of Aligos Therapeutics, expressed his gratitude to the patients, their families, and the investigators involved in reaching this milestone. He also welcomed Dr. Loomba, highlighting his significant contributions to the MASH field, particularly his pioneering work with MRI-PDFF as a noninvasive test to assess liver steatosis.

Dr. Loomba is a prominent figure in gastroenterology and hepatology. He holds the position of Chief of the Division of Gastroenterology and Hepatology and is a Professor of Medicine at the University of California, San Diego (UCSD). In addition, he directs the UCSD NAFLD Research Center. Dr. Loomba's educational background includes a fellowship in gastroenterology at UCSD and a hepatology fellowship at the National Institutes of Health (NIH). He earned his medical degree from the Armed Forces Medical College in India and a Master of Health Science in clinical research from Duke University School of Medicine.

The HERALD study is a randomized, double-blind, placebo-controlled trial that enrolled approximately 100 participants with presumed MASH and stage 1-3 liver fibrosis. The subjects were randomized to receive one of four doses of ALG-055009 or a placebo, administered orally once daily for 12 weeks. The primary endpoint of the study is the relative change in liver fat content measured by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) at week 12. Additionally, the study will evaluate safety, pharmacokinetics (PK), and other non-invasive biomarkers.

ALG-055009, which has shown promising results in earlier stages, aims to serve as a best-in-class thyroid hormone receptor beta (THR-ß) agonist for MASH treatment. Preliminary data from Phase 1 trials indicated that ALG-055009 was well tolerated, with dose-proportional pharmacokinetics and low variability, demonstrating the expected thyromimetic effects. The Phase 2a HERALD study aims to further assess the safety, PK, and multiple efficacy biomarkers of ALG-055009.

MASH, a severe condition resulting from the accumulation of fat in the liver due to poor diet and lack of exercise, affects a significant portion of the global population. As of 2019, about 30% of the global population was estimated to have metabolic dysfunction-associated steatotic liver disease (MASLD). Between 1.5% and 6.5% of these individuals develop MASH, characterized by an ongoing inflammatory response to excess fat deposits in the liver. In the U.S., the prevalence of MASH is expected to rise from approximately 16.5 million in 2015 to 27.0 million by 2030. Without changes in diet and exercise, MASH can lead to progressive liver fibrosis and cirrhosis, resulting in serious health complications such as hepatocellular carcinoma, the need for liver transplants, and increased mortality.

Founded in 2018, Aligos Therapeutics aims to become a leader in treating liver and viral diseases. The company's strategy leverages its team's extensive expertise in developing therapeutics for MASH and viruses with high unmet medical needs, such as hepatitis B and coronaviruses.