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
Excerpt from the Press Release:
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.”
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