“ PBGENE-HBV preclinical data reinforce safety profile and potential to deliver a functional cure for chronic hepatitis B, supporting advancement into first-in-human clinical study “
“ Phase 1 dose escalation and expansion trial, ELIMINATE-B, designed to assess safety and efficacy measured by durable reduction of key viral biomarkers “
“ Global study recruiting patients following clearance of first clinical trial application (CTA), with additional CTAs pending approval; U.S. investigational new drug (IND) anticipated in 2025 “
“ Investor event today, November 15, 10:00 a.m. EST / 7:00 a.m. PST, to feature presentations from company management and key opinion leader perspectives on PBGENE-HBV “
DURHAM, N.C.–(BUSINESS WIRE)–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 (NASDAQ:). 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…
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