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Precision BioSciences Submits First Clinical Trial Applications to Initiate Phase 1 Trial for PBGENE-HBV for the Treatment of Chronic Hepatitis B
- PBGENE-HBV is the only drug modality designed to target the root cause of disease by eliminating cccDNA and inactivating integrated HBV - Clinical trial
About this update from Precision Biosciences, Inc.
[{"type":"text","content":"\n- PBGENE-HBV is the only drug modality designed to target the root cause of disease by eliminating cccDNA and inactivating integrated HBV\n\n- Clinical trial applications submitted for the first gene editing approach for chronic hepatitis B\n\n- Final clinical candidate safety data and plans for the Phase 1 trial to be shared in November prior to the American Association for the Study of Liver Diseases meeting\n\n DURHAM, N.C.--(BUSINESS WIRE)--\nPrecision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, today announced that the Company submitted Clinical Trial Applications (CTA) to initiate a Phase 1 study evaluating PBGENE-HBV. PBGENE-HBV is the Company’s wholly owned in vivo gene editing program designed to potentially cure chronic hepatitis B virus (HBV) by eliminating cccDNA, the key source of replicating hepatitis B virus, while also inactivating integrated HBV DNA in hepatocytes.\n\n“The CTA submissions for PBGENE-HBV are important milestones for Precision as we pioneer this potentially curative therapy for chronic hepatitis B. These regulatory submissions are the culmination of our team’s dedication, commitment and highly productive interactions with global regulators as we develop the first clinical stage in vivo gene editing program for chronic hepatitis B virus, recognized as one of the largest global public health problems by the World Health Organization with an estimated 300 million people afflicted globally,” said Michael Amoroso, Chief Executive Officer of Precision BioSciences. “Our comprehensive regulatory package, supported by robust non-human primate (NHP) safety studies, the gold standard model for predicting safety in humans, and efficacy in numerous preclinical models of hepatitis B including in NHPs enables us to proceed with planned regulatory submissions in multiple markets around the world. We recently bolstered our clinical team expertise while building a world class hepatitis scientific advisory board to assist in guiding execution of our global Phase 1 trial. Our goal is clear, to generate robust clinical data for the patients afflicted with hepatitis B who are counting on us to significantly increase their chance of achieving a functional cure.”\n\nDr. Murray A...