Benzinga | Oct 30, 2020 08:02AM EDT

Aligos Therapeutics Doses First Subject in Phase 1 Proof-of-Concept Study of Small Molecule Drug Candidate ALG-000184 for Chronic Hepatitis B

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 it has dosed its first subject in a first-in-human Phase 1a/b clinical trial, ALG-000184-201 (NCT04536337). The study will evaluate ALG-000184, a small molecule class II capsid assembly modulator (CAM) that targets hepatitis B virus (HBV) capsid assembly as well as the establishment of covalently closed circular DNA (cccDNA).

"We are excited to advance ALG-000184 into clinical studies," said Lawrence Blatt, Ph.D., MBA, Chief Executive Officer of Aligos. "In collaboration with Dr. Raymond Schinazi's laboratory at Emory University, our experienced discovery and development team has optimized ALG-000184 to have best-in-class pharmacological potential. We look forward to learning how these optimized drug properties may translate into benefits for patients living with chronic hepatitis B."

Matthew W. McClure, M.D., Chief Medical Officer at Aligos, noted, "ALG-000184-201 is a multipart Phase 1a/1b umbrella trial that will evaluate the safety and pharmacokinetics of single and multiple ascending doses of ALG-000184 in healthy volunteers, and the antiviral activity of ALG-000184 given once-daily over 28 days in patients with chronic hepatitis B (CHB). This is Aligos' second CHB drug candidate to enter the clinic this year and we expect the 201 study will provide important proof of concept data related to the antiviral activity of ALG-000184. We look forward to sharing initial topline results from this study in the second half of 2021."

ALG-000184 is one of several drug candidates in Aligos' chronic hepatitis B (CHB) portfolio, which targets different clinically validated mechanisms of action in the HBV life cycle. The portfolio also includes: ALG-010133, a S-antigen Transport-inhibiting Oligonucleotide Polymers (STOPSTM) molecule, which entered clinical development earlier this year; ALG-020572, an antisense oligonucleotide (ASO); and ALG125097, a small interfering RNA (siRNA). Initially, Aligos plans to evaluate the antiviral activity of each of these drug candidates individually in Phase 1 umbrella trials before evaluating them in combination in subsequent trials.