A Study Evaluating ABI-H0731 as Adjunctive Therapy in Patients With Chronic Hepatitis B

This is a Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731
as Adjunctive Therapy in Virally-suppressed Patients with Chronic Hepatitis B

Key Inclusion Criteria:

- Male or female between ages 18 and 70 years

- Virologically-suppressed (defined as HBV DNA ≤LOQ) for at least 6 months before
screening on SOC NUC therapy

- HBeAg-positive or HBeAg-negative at screening

- In good general health except for chronic HBV infection

Key Exclusion Criteria:

- Co-infection with HIV, HCV, HEV or HDV

- History or evidence of hepatic decompensation (including gastrointestinal bleeding or
esophageal varices) at any time prior to or at time of screening

- Clinically significant cardiac or pulmonary disease, chronic or recurrent renal or
urinary tract disease, liver disease other than HBV, endocrine disorder, autoimmune
disorder, diabetes mellitus requiring treatment with insulin or hypoglycemic agents,
neuromuscular, musculoskeletal, or mucocutaneous conditions requiring frequent
treatment, seizure disorders requiring treatment, or other medical conditions
requiring frequent medical management or pharmacologic or surgical treatment that in
the opinion of the Investigator or the Sponsor makes the subject unsuitable for the
study

- Previous treatment with an investigational agent for HBV other than ABI-H0731 in the
last 6 months before screening

- History of HCC

- Females who are lactating or pregnant or wish to become pregnant are excluded from the
study

- Exclusionary laboratory parameters at screening include:

- Platelet count <100,000/mm3

- Albumin
- Direct bilirubin >1.2×ULN

- ALT >5×ULN at screening

- International Normalized Ratio (INR) >1.5×ULN

- Glomerular filtration rate (GFR) <60 mL/min/1.73 m2 by CKD-EPI equation