Assembly Biosciences Presents Data from HBV Core Inhibitor Programs in Poster Sessions at the 2020 AASLD The Liver Meeting Digital Experience - Seite 2

The Liver Meeting Digital Experience 2020 Presentations:
The posters will be made available on the “Events and Presentations” page in the Investors section of assemblybio.com.

Vebicorvir (VBR, or ABI-H0731), Assembly Bio’s Lead HBV Core Inhibitor
Poster Presentation 820: Analysis of the longer-term safety profile of the hepatitis B virus core inhibitor VBR in an open-label extension study
Presenter: Ira M. Jacobson, MD, Director, Hepatology, NYU Langone Health

This poster includes data from a controlled comparison of 24 patients receiving placebo + nucleos(t)ide analogs (NrtI) for 24 weeks versus 95 patients receiving Assembly Bio’s lead core inhibitor product VBR + NrtI for up to 1.5 years. Data support the differentiated safety profile and continued development of VBR combination therapy.

Key Results:

• The safety profile of combination treatment with VBR+NrtI was similar to placebo+NrtI over a 24-week controlled-comparison and was stable with longer-term treatment of VBR+NrtI up to 1.5 years.
• Rashes without systemic involvement observed with VBR+NrtI treatment were predominantly Grade 1 resolving without VBR+NrtI interruption.
• There was no pattern of increased alamine aminotransferase (ALT) and/or aspartate aminotransferase (AST), indicative of hepatoxicity.
  

Late-Breaking Poster LP37: Changes in viral antigens are more strongly associated with HBV pgRNA than HBV DNA in studies of vebicorvir and NrtI in treatment-naive patients with chronic HBV infection
Presenter: Mark Sulkowski, MD, Medical Director, Viral Hepatitis Center, Johns Hopkins University School of Medicine

This poster details the results of post hoc analyses of data from studies of VBR in treatment naïve patients with HBeAg positive chronic HBV infection to better understand the correlations between changes in HBV DNA and pgRNA with those of other HBV antigens. Two approaches were used: correlation analyses with a Pearson’s coefficient and a Mixed-Effects Model for Repeated Measures. These results demonstrate the importance of pgRNA as a meaningful biomarker for chronic HBV.

Key Results:

• Changes in other HBV antigens are more strongly associated with the change in pgRNA compared with the change in HBV DNA.
• Correlations between pgRNA and HBeAg and HBcrAg were greater relative to the correlations with HBsAg, likely due to the substantial contribution of HBV integrants to HBsAg levels.
• A >2 log₁₀ decline in pgRNA in patients receiving VBR + entecavir (ETV) more significantly predicted the decline in the HBeAg and HBcrAg consistent with the second phase decline with core inhibitor treatment reflecting reduction in cccDNA pools.

Assembly Bio’s Next-Generation of Core Inhibitors