DURHAM, N.C.– Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, today will present preclinical data supporting the advancement of PBGENE-HBV into clinical development. The Company will also outline the design of its first-in-human study, ELIMINATE-B, in patients with chronic hepatitis B. Company management will present these updates and host panel discussions on the unmet need in chronic hepatitis B and the approach to treatment with PBGENE-HBV during a virtual event being held today, November 15, 10:00 a.m. EST / 7:00 a.m. PST before commencement of the American Association for the Study of Liver Diseases (AASLD) Meeting.
“We are excited to share the preclinical data supporting PBGENE-HBV alongside the design of our Phase 1 trial, ELIMINATE-B, which will be the first clinical study of an in vivo gene editing program in chronic hepatitis B,” said Michael Amoroso, Chief Executive Officer, Precision BioSciences. “Chronic hepatitis B affects approximately 300 million people globally and represents a multi-billion-dollar market with chronic treatments currently serving more than 5 million patients worldwide. However, most available treatments for chronic hepatitis B target downstream aspects of the viral lifecycle, leaving the root of disease intact. Consequently, less than 3% of patients treated with existing approved treatments achieve a functional cure. This is unacceptable considering that up to 40% of patients with chronic hepatitis B will progress to develop life-threatening liver disease or liver cancer. PBGENE-HBV is uniquely designed to address this unmet need at the source of viral replication.”
“Our preclinical results reflect the robust data package submitted to regulators in support of our global Phase 1 trial and underscore our conviction in PBGENE-HBV, which has so far demonstrated compelling safety and selectivity, highly efficient editing, and confirmation of its mechanism to eliminate cccDNA and viral DNA integrated into hepatocytes,” said Murray Abramson, M.D., M.P.H., Head of Clinical Development, Precision BioSciences. “Importantly, the ELIMINATE-B study will evaluate patients who are controlled but not cured by nucleoside analogues. We believe ELIMINATE-B will highlight the differentiated mechanism of PBGENE-HBV. By simultaneously targeting the two distinct drivers of disease – cccDNA and viral DNA integrated into hepatocytes – PBGENE-HBV has the potential to deliver a much-needed functional cure for people living with chronic hepatitis B.”
Mr. Amoroso added, “With regulatory authorization in place and global sites coming online, we are excited to begin dosing patients with PBGENE-HBV and look forward to sharing clinical data as it matures in 2025.”
