Precision Biosciences Inc. has submitted its first clinical trial applications (CTAs) to initiate a phase I study evaluating PBGENE-HBV, an in vivo gene editing program designed to potentially cure chronic hepatitis B virus (HBV).
The persistence of hepatitis B virus (HBV) covalently closed-circular DNA (cccDNA) and integration of HBV DNA into the hepatocytes lead to chronic HBV infection. Current therapies achieve long-term viral suppression but, as HBV cccDNA is not eradicated, lifelong treatment is needed.
Precision Biosciences Inc. has received pre-IND regulatory feedback from the FDA and ex-U.S. agencies providing alignment and clarity on Precision's final IND/CTA-enabling preclinical plans and clinical strategy for PBGENE-HBV.
Precision Biosciences Inc. uses its proprietary Arcus platform to develop in vivo gene editing therapies and has outlined new data from its wholly owned and partnered pipeline.
