Aligos Therapeutics Announces the Completion of Enrollment in the ALG-055009 Phase 2a HERALD Study for the Treatment of MASH

Topline data now projected in early Q4 2024

Rohit Loomba, MD, MHSc to serve as Principal Investigator

SOUTH SAN FRANCISCO, Calif., May 21, 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 it has completed enrollment in the ALG-055009 Phase 2a HERALD study for metabolic dysfunction-associated steatohepatitis (MASH) with topline safety and efficacy data anticipated in early Q4 2024. The company also announced that Dr. Rohit Loomba will serve as Principal Investigator for the study.

“Completing enrollment in our first Phase 2a trial is a tremendous accomplishment for the Aligos team,” said Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer at Aligos Therapeutics. “We thank the patients, their families and our investigators for their efforts. In addition, I’d like to welcome Dr. Rohit Loomba as our Principal Investigator for the HERALD study. Dr. Loomba has a broad track record of contributions to the MASH field, having pioneered the use of MRI-PDFF as a noninvasive test to assess liver steatosis. We look forward to his insights and contributions to the HERALD study and beyond.”

Dr. Loomba is the Chief of the Division of Gastroenterology and Hepatology and Professor of Medicine at the University of California, San Diego (UCSD). He is also the Director of the UCSD NAFLD Research Center. Dr. Loomba completed a fellowship in gastroenterology at the UC San Diego School of Medicine and a fellowship in hepatology at the National Institutes of Health (NIH) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Dr. Loomba 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.

“I am pleased to serve as the Principal Investigator for the Phase 2a HERALD study,” stated Rohit Loomba, MD, MHSc, Chief, Division of Gastroenterology and Hepatology, University of California, San Diego. “The excellent potency and PK profile makes ALG-055009 a compelling potential treatment option for MASH patients. I look forward to working with the team to complete this study.”

HERALD (NCT06342947) is a randomized, double-blind, placebo-controlled trial that has enrolled approximately 100 subjects with presumed MASH and stage 1-3 liver fibrosis (F1-F3). Subjects were 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. The primary endpoint is relative change in liver fat content by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) at week 12. Safety, pharmacokinetics (PK) and other non-invasive biomarkers/tests previously shown to be impacted by treatment with thyroid hormone receptor beta (THR-ß) agonists will also be evaluated.