Benzinga | Jan 26, 2022 08:06AM EST

Aligos Therapeutics Begins Dosing In Chronic Hepatitis B Patients In Its Phase 1 Antisense Oligonucleotide Study

Aligos Therapeutics, Inc. (NASDAQ:ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that the first chronic hepatitis B (CHB) patient has been dosed in the multiple ascending dose (MAD) portion of Study ALG-020572-401 (NCT05001022) which is evaluating antisense oligonucleotide (ASO) ALG-020572.

"We are pleased to have initiated the MAD phase of this study in CHB patients," said Lawrence M. Blatt, Ph.D., MBA, Chairman and CEO of Aligos. "As with our earlier CHB portfolio drugs entering Phase 1 studies, we plan to evaluate multiple dose levels in patients to determine the risk-benefit profile for ALG-020572 before advancing it into combination studies with other drugs."

Study ALG-020572-401 is a Phase 1a/1b umbrella study, which is evaluating the safety, pharmacokinetics, and pharmacodynamics (Phase 1b) of the ASO ALG-020572 when given subcutaneously as single doses to healthy volunteers (HVs) or 7 doses over 29 days in CHB patients. Dosing in HVs is nearly complete, with the highest administered dose level being 480 mg. Multiple cohorts are planned in the MAD portion of the study to evaluate the risk-benefit profile of ALG-0202572, including its dose-response effect on viral markers, potentially in multiple CHB subpopulations. The first MAD cohort will evaluate a dose of 210 mg in HBeAg negative, virologically suppressed CHB patients. Results of this and subsequent cohorts will be presented at a future scientific conference.