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Aligos Therapeutics Announces the Selection of Stephen Harrison, MD as Principal Investigator of Ph2a Study and Key Study Design Elements/Milestones for NASH Drug Candidate, ALG-055009
- Phase 1 study conduct complete with preliminary data indicating THR-beta agonist ALG-055009 was well-tolerated with a favorable PK profile and dose
About this update from Aligos Therapeutics, Inc.
[{"type":"text","content":"- Phase 1 study conduct complete with preliminary data indicating THR-beta agonist ALG-055009 was well-tolerated with a favorable PK profile and dose responsive changes in relevant biomarkers -Upcoming randomized, double blind, placebo-controlled Ph2a study will evaluate the safety, PK, and efficacy (MRI-PDFF and other biomarkers) of ALG-055009 in NASH subjects after dosing x 12 weeks -Dr. Stephen Harrison appointed Principal Investigator of Ph2a study -US IND on track to be filed in Q4 2023 -Anticipated Ph2a topline results in Q4 2024 SOUTH SAN FRANCISCO, Calif., July 19, 2023 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced the selection of Stephen Harrison, MD as principal investigator of, and key design elements for, its upcoming Ph2a study of NASH drug candidate ALG-055009. The company has now completed Phase 1 testing (NCT05090111), where single oral ≤4 mg doses and 14 daily ≤1.0 mg doses of ALG-055009 were found to be well tolerated with linear PK, low variability and expected effects on biomarkers, including generally dose responsive reductions in various atherogenic lipids and increases in sex hormone binding globulin, a marker of target engagement. “We have made significant progress over the past several months wrapping up the Ph1 study and defining the upcoming Ph2a study of our oral THR-β drug candidate, ALG-055009,” noted Matthew W. McClure, MD, Chief Medical Officer of Aligos Therapeutics. “Thanks to the expertise of the study’s Principal Investigator, Dr. Stephen Harrison, who is a world-class thought leader in NASH drug development, we have recently been able to define many of the key design elements of this important study. Specifically, the preliminary design is as a US-based, randomized, double blind, placebo-controlled Ph2a study in NASH subjects that will evaluate the safety, PK, and efficacy (as measured by MRI-PDFF and other biomarkers) after dosing for 12 weeks with ALG-055009. The trial will assess a broad range of ALG-055009 dose levels across parallel arms in order to define the optimal risk-benefit profile before initiating longer term, biopsy-based clinical trials. We remain on track to file the Ph2a protocol in Q4 2023 and antici...