Benzinga | Apr 14, 2021 08:11AM EDT

Aligos Therapeutics Says Begins Dosing With Capsid Assembly Modulator Drug Candidate, ALG-000184, In First Cohort Of Chronic Hepatitis B Patients In Phase 1 Proof-Of-Concept 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 company has started dosing in the first cohort of chronic hepatitis B (CHB) patients in the ongoing ALG-000184-201 study (NCT04536337). The trial is evaluating ALG-000184, a proprietary Class II capsid assembly modulator (CAM) designed to inhibit viral replication, as determined by HBV DNA and RNA levels.



"To fully suppress the hepatitis B virus, we believe you must not only remove the immunosuppressive effects of high S-antigen levels using oligonucleotide drug candidates such as our STOPS(tm) molecule, ALG-010133, but also inhibit replication of the virus using small molecule drug candidates such as our CAM, ALG-000184," said Lawrence Blatt, Ph.D., MBA, Chief Executive Officer of Aligos. "We believe combination approaches such as giving ALG-010133 and ALG-000184 together with a nucleos(t)ide analog therapy have the potential to achieve higher rates of functional cure than with current standard of care."

Matthew W. McClure, M.D., Chief Medical Officer of Aligos, added, "ALG-000184 has demonstrated potent inhibition of HBV DNA and RNA levels in preclinical studies. This observation, coupled with the drug's clinical profile to date, led us to initiate dosing with ALG-000184 in CHB patients to assess its ability to suppress HBV DNA and RNA levels. We expect to begin reporting safety, pharmacokinetic, and antiviral activity data for ALG-000184 from the initial patient cohorts of this study in the second half of 2021."

Professor Ed Gane, MB ChB, Principal Investigator for the ALG-000184-201 study, added, "I believe that combinations of drugs that collectively reduce S-antigen and HBV DNA/RNA levels have the potential to achieve significantly higher rates of functional cure than the current standard of care. By advancing their STOPS molecule drug candidate, ALG-010133, and now their CAM drug candidate, ALG-000184, separately into CHB patients, Aligos is laying the groundwork for future combination studies in CHB, where we can test this important hypothesis."

ALG-000184-201 (NCT04536337) is a multi-part umbrella trial that is evaluating the safety, pharmacokinetics (PK) and antiviral activity of up to 28 daily oral doses of ALG-000184 in treatment-na?ve CHB patients as well as CHB patients not currently being treated. The study also previously evaluated the safety and PK of up to 7 oral daily doses of ALG-000184 in 48 healthy volunteers and preliminary data indicate that ALG-000184 has a good safety and PK profile and can achieve drug levels expected to confer antiviral activity.

Aligos' CAM 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, antisense oligonucleotide (ASO), 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.