"FDA Grants Fast Track Designation To Hepatitis B Drug"
The FDA recently granted Fast Track designation to Assembly Biosciences, Inc’s novel treatment for patients with chronic hepatitis B virus (HBV) infection. The drug, ABI-H0731, is the manufacturer’s lead oral HBV core inhibitor. It is currently being evaluated in a pair of global phase 2a proof of concept studies. "Even with indefinite treatment with the currently available nucleoside and nucleotide inhibitors, we are not able to fully suppress viral replication, which will be necessary for patients to achieve a cure for chronic HBV," said Douglas T. Dieterich, MD, director of the Institute of Liver Medicine and professor of medicine and liver disease at the Icahn School of Medicine at Mount Sinai, who is an investigator on both trials. "Core inhibitors target different parts of the HBV life cycle than the current therapies and may result in both greater viral suppression and increased loss of cccDNA, which is central to HBV persistence. Combining these new mechanisms of action with existing direct acting antivirals looks promising. I look forward to exploring this further in the trials and seeing the results."
- Douglas Dieterich, MD, Director, Institute of Liver Medicine, Professor, Liver Disease, Icahn School of Medicine at Mount Sinai