Despite a preventive vaccine and available therapies, there is currently no cure for chronic HBV infection
ATI-2173 – a descendent of clevudine
Clevudine, a first generation ASPIN, was originally developed for the treatment of chronic HBV. In humans, monotherapy demonstrated equivalent antiviral efficacy to ETV after 48 weeks1. Its mechanism of action uniquely demonstrated extended viral suppression following treatment discontinuation out to 24 weeks2. However, clevudine was not liver targeted. It was voluntarily discontinued in Phase 3 by its developer, Pharmasset, due to reversible proximal skeletal muscle myopathy, which emerged after a minimum of 8 months of dosing (median exposure 16 months, 1% of patients at one year). This adverse event was also observed in a 12-month clevudine monkey toxicology program with a dose and duration relationship 3. Aside from this rare adverse event, clevudine demonstrated a well-defined safety profile and efficacy data from 1,500+ HBV-infected subjects. Further, combination treatment with adefovir demonstrated improved virological response with no viral resistance detected4.