Assembly Biosciences gets FDA fast track for hepatitis B treatment
Assembly Biosciences has been granted Food and Drug Administration fast-track designation for ABI-H0731 for the treatment of patients with chronic hepatitis B infection.
ABI-H0731 is Assembly’s lead oral HBV core inhibitor, which is being evaluated in two global Phase 2a proof of concept studies that are currently enrolling patients, the company said.
“More than one million individuals in the United States suffer from chronic hepatitis B infection, which can progress to cirrhosis and liver cancer, eventually leading to death. Despite existing antiviral therapies, cures are rare, so the need for more effective and potentially curative treatments is tremendous,” Assembly Biosciences chief medical officer Uri Lopatin said. “We are encouraged that ABI-H0731 was granted Fast Track Designation. This will allow us to work closely with the FDA in our efforts to bring this new therapy to HBV patients as quickly as possible.”
ABI-H0731 is Assembly’s lead oral HBV core inhibitor, which is being evaluated in two global Phase 2a proof of concept studies that are currently enrolling patients, the company said.
“More than one million individuals in the United States suffer from chronic hepatitis B infection, which can progress to cirrhosis and liver cancer, eventually leading to death. Despite existing antiviral therapies, cures are rare, so the need for more effective and potentially curative treatments is tremendous,” Assembly Biosciences chief medical officer Uri Lopatin said. “We are encouraged that ABI-H0731 was granted Fast Track Designation. This will allow us to work closely with the FDA in our efforts to bring this new therapy to HBV patients as quickly as possible.”