Ob Kursrelevant ?? ..Mal schauen... Precision BioSciences Receives Approval in Hong Kong to Expand PBGENE-HBV Phase 1 ELIMINATE-B Trial for the Treatment of Chronic Hepatitis B
- Approval in Hong Kong marks the first clinical trial application clearance of an in vivo gene editing approach for chronic hepatitis B in Hong Kong and the second CTA approval for PBGENE-HBV in 2024
- ELIMINATE-B is a global, multi-site study now actively recruiting patients; expected to report clinical data as it matures throughout 2025
- U.S. investigational new drug (IND) anticipated in 2025
December 18, 2024 07:01 AM Eastern Standard Time
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 announced that it has received Clinical Trial Application (CTA) approval in Hong Kong to study PBGENE-HBV in the ongoing ELIMINATE-B Phase I trial. PBGENE-HBV is Precision’s lead wholly owned in vivo gene editing program designed to cure chronic hepatitis B by eliminating cccDNA, the key source of replicating hepatitis B virus (HBV), and inactivating integrated HBV DNA in hepatocytes. The company is actively recruiting patients for the ELIMINATE-B trial in Moldova and has begun activating a top infectious disease clinical site in Hong Kong as part of its global regulatory and clinical operations strategy.
“We are pleased to receive our second CTA approval for PBGENE-HBV, expanding our ELIMINATE-B trial into a world-class HBV clinical trial site in Hong Kong”
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“We are pleased to receive our second CTA approval for PBGENE-HBV, expanding our ELIMINATE-B trial into a world-class HBV clinical trial site in Hong Kong,” said Dr. Murray Abramson, Senior Vice President, Head of Clinical Development of Precision BioSciences. “PBGENE-HBV has been designed to target a viral site that is prevalent across all HBV genotypes, including in Asia, and we believe that this will enable us to evaluate and provide access to as many patients as possible. In addition to Hong Kong, our clinical trial site in Moldova continues to execute as planned, and we look forward to sharing clinical data as it matures throughout 2025.”
