We are developing capsid inhibitors as oral therapeutics for the treatment of chronic HBV infection. By inhibiting assembly of the viral capsid, the ability of hepatitis B virus to replicate is impaired, resulting in reduced cccDNA.
Our first-generation capsid inhibitor, AB-423, was evaluated in a Phase I Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) trial in healthy volunteers, which was generally well-tolerated with no serious adverse events following single doses up to 800mg and multiple doses up to 400mg twice daily. AB-423’s favorable safety and pharmacokinetics (PK) profile following single and multiple doses in healthy volunteers supports further evaluation in our multiple-dose administration study of AB-423 in patients with chronic HBV. Following initial studies of AB-423 in HBV patients, we will consider inclusion in a combination study with our other proprietary HBV assets, nucleot(s)ide analog, and interferon therapies.
AB-506 is a next-generation capsid inhibitor currently undergoing Investigational New Drug (IND)-enabling studies. In preclinical studies, this new capsid inhibitor has demonstrated favorable PK and potency profiles. Pending successful IND-enabling studies, this product candidate could be the subject of an Investigation New Drug (or equivalent) filing.