Aligos Therapeutics Begins Dosing with Antisense Oligonucleotide Drug Candidate, ALG-020572, in Healthy Volunteers in a Phase 1 Proof-of-Concept Study
- Category: DNA RNA and Cells
- Published on Tuesday, 12 October 2021 11:11
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Aligos now evaluating three of its four chronic hepatitis B (CHB) portfolio drug candidates in clinical trials
SOUTH SAN FRANCISCO, CA, USA I October 11, 2021 I 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 company has started dosing in the first cohort of healthy volunteers in Study ALG-020572-401 (NCT05001022). The trial is evaluating ALG-020572, a proprietary antisense oligonucleotide (ASO) therapeutic candidate that is designed to reduce circulating HBsAg (Hepatitis B surface antigen) levels.
“This is the second drug candidate we have advanced to clinical development that targets HBsAg reductions in chronic hepatitis B patients,” said Lawrence Blatt, Ph.D., MBA, Chairman and Chief Executive Officer of Aligos. “The mechanism of our ASO molecule is specifically designed to selectively seek out and destroy viral messenger RNA and utilizes third generation XNA chemistry devised to improve the pharmacological characteristics of the molecule. We are hopeful these enhanced properties will augment the candidate’s antiviral activity in the clinic.”
Professor Ed Gane, MB ChB, Principal Investigator for the ALG-020572-401 study, added, “I believe that reducing HBsAg levels is an essential step in achieving functional cure. Other ASOs have demonstrated substantial HBsAg reductions in the clinic. Given that ALG-020572 appears to have more potent antiviral activity and enhanced hepatocyte targeting via GalNAc than other ASOs, a combination regimen containing ALG-020572 may have the potential to achieve higher rates of functional cure.”
Study ALG-020572-401 is a two-part umbrella protocol. In Part 1, it will evaluate the safety, tolerability and pharmacokinetics (PK) of single subcutaneous (SC) doses of ALG-020572 in healthy volunteers. In Part 2, it will evaluate the safety, PK, and antiviral activity of multiple SC doses given over 28 days in multiple chronic hepatitis B (CHB) subpopulations.
Aligos’s ASO program represents one of several in the company’s CHB portfolio that target different clinically validated mechanisms of action in the hepatitis B virus life cycle. The portfolio also includes S-antigen Transport-inhibiting Oligonucleotide Polymer (STOPSTM) molecules, capsid assembly modulators (CAMs), and small interfering RNA (siRNA) drug candidates. The properties of these candidates indicate that their use in combination could yield potentially best-in-class treatment regimens that may achieve higher rates of functional cure than current standard of care. For each of these drug candidates, Aligos plans to initially establish proof of concept as monotherapy in Phase 1 umbrella trials before evaluating them in combination in subsequent trials.
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 viral infections and liver diseases. Aligos is focused on the discovery and development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos’s strategy is to harness the deep expertise and decades of drug development experience its team has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.
SOURCE: Aligos Therapeutics