Aligos Therapeutics Announces IND Clearance for NASH lead, ALG-055009

- Phase 2a NASH protocol on track to be submitted to the IND in Q4 2023, enrollment expected to begin in Q1 2024

SOUTH SAN FRANCISCO, Calif., Sept. 21, 2023 (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 it has received clearance of its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) for ALG-055009, it’s thyroid hormone receptor beta agonist (THR-β), intended for the treatment of nonalcoholic steatohepatitis (NASH).

“This is an important milestone for the development of our potentially best-in-class THR-β agonist, ALG-055009,” said Lawrence Blatt, Ph.D., MBA, Chairman & Chief Executive Officer of Aligos Therapeutics. “Equally important, we remain on track to submit the Phase 2a protocol to the IND in Q4 2023 and expect to initiate enrollment in Q1 2024. We look forward to sharing topline proof of concept data from the study in Q4 2024.”

Matthew W. McClure, M.D., Chief Medical Officer of Aligos, added, “ALG-055009 is the most potent known THR-β agonist in clinical development and has demonstrated enhanced beta selectivity preclinically and favorable pharmacokinetics in the recently completed Phase 1 first-in-human study. Our focus now is on successfully conducting the Phase 2a study alongside Dr. Stephen Harrison, the trial’s Principal Investigator.”

The study is designed to evaluate the safety and efficacy of up to 4 dose levels of ALG-055009, compared to placebo, over a 12-week treatment period in presumed NASH patients. As is typical for studies at this phase of development, the study’s primary endpoint will be change in MRI-PDFF, which has been shown to correlate with liver histology with other THR-β agonists in development.

About Aligos

Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of liver and viral diseases. Aligos’ strategy is to harness the deep expertise and decades of drug development experience its team has in liver and viral diseases to discover and develop potentially best in class therapeutics for nonalcoholic steatohepatitis (NASH) and viruses with high unmet medical need such as coronaviruses and chronic hepatitis B (CHB).