- Precision BioSciences (DTIL, Financial) receives FDA Fast Track designation for its gene editing therapy, PBGENE-HBV.
- The Phase 1 ELIMINATE-B trial for PBGENE-HBV is currently underway in multiple countries, including the U.S., with updates expected through 2025.
- The Fast Track status from the FDA could expedite the development and review process for this chronic hepatitis B treatment.
Precision BioSciences, Inc. (DTIL), a clinical-stage gene editing company, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for PBGENE-HBV, its leading gene editing program targeting chronic hepatitis B. This therapy aims to cure the disease by eliminating cccDNA and inactivating integrated HBV DNA in hepatocytes.
The company's Phase 1 ELIMINATE-B trial is a global clinical investigation being conducted in the United States, Moldova, Hong Kong, New Zealand, and the United Kingdom. The initial safety and antiviral activity results have shown promise, with detailed data on the full low-dose cohort and higher dose levels expected throughout 2025.
The Fast Track designation facilitates the development process and includes benefits such as more frequent communication with the FDA, rolling review of marketing applications, and potential Priority Review eligibility. These regulatory advantages are particularly valuable for Precision BioSciences, a company with a market cap of $46.7 million, as they can reduce the time to market and conserve resources.
PBGENE-HBV represents a novel approach that targets the root cause of chronic hepatitis B rather than just suppressing viral replication. This differentiation could offer significant clinical benefits and positions Precision BioSciences as a potential leader in the treatment of this disease, which affects approximately 300 million people worldwide.
