What's Happening?
Precision BioSciences has announced promising Phase 1 results for its PBGENE-HBV gene therapy in the ELIMINATE-B trial, targeting chronic hepatitis B. The trial's Cohort 1, which received the lowest dose level, showed substantial antiviral activity and a safe profile across multiple administrations. The therapy aims to eliminate covalently closed circular DNA (cccDNA) and inactivate integrated DNA, potentially offering a complete cure for hepatitis B. The trial is progressing to Cohort 2, with higher doses being tested, and has extended its cash runway to support ongoing development.
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Why It's Important?
The development of PBGENE-HBV represents a significant advancement in the treatment of chronic hepatitis B, a disease affecting millions globally. Current treatments only suppress the virus, requiring lifelong administration, whereas PBGENE-HBV aims to provide a complete cure by targeting the genetic source of the disease. Successful development of this therapy could drastically improve patient outcomes, reduce the risk of liver cancer, and transform the management of hepatitis B. The trial's progress and extended cash runway indicate strong potential for further clinical advancements.
What's Next?
Precision BioSciences plans to continue the ELIMINATE-B trial, escalating doses to determine the optimal therapeutic index for PBGENE-HBV. The company aims to achieve a complete cure by eliminating cccDNA and inactivating integrated HBV DNA. The trial will expand to include more diverse patient populations and additional clinical sites. Precision BioSciences expects to provide further data updates later in 2025, with plans to initiate Phase 2 studies and potentially pivotal trials for other programs.
