- Precision BioSciences (DTIL, Financial) presented initial safety data from the Phase 1 ELIMINATE-B trial at the 2025 EASL Congress.
- PBGENE-HBV, a gene editing therapy for chronic hepatitis B, showed promising safety results with no serious adverse events.
- The FDA granted Fast Track designation to PBGENE-HBV in April 2025, highlighting its potential in treating chronic hepatitis B.
Precision BioSciences, Inc. (DTIL) announced the initial safety data from its Phase 1 ELIMINATE-B trial evaluating PBGENE-HBV, a gene editing therapy designed for chronic hepatitis B treatment. The data was presented during a late-breaking poster session at the 2025 European Association for the Study of the Liver (EASL) Congress in Amsterdam, Netherlands.
The initial cohort included three male participants, with a mean age of 41 years, who have been on nucleos(t)ide analog treatment for 5.9 to 7.2 years. Participants received repeat administrations of PBGENE-HBV at a dose level of 0.2 mg/kg. The therapy was well-tolerated with no dose-limiting toxicities, serious adverse events, or clinically significant laboratory abnormalities observed. Adverse events were mild and transient, supporting the therapy's ongoing dose escalation strategy.
Precision BioSciences has activated global clinical sites and is enrolling patients to further assess the therapy's efficacy and safety. The PBGENE-HBV program recently gained Fast Track designation from the FDA, underlining its potential to address the unmet needs of chronic hepatitis B patients.
Chronic hepatitis B is a leading cause of morbidity and death globally, affecting approximately 300 million people worldwide and 2.4 million in the US. Precision BioSciences aims to deliver a lasting solution, leveraging its novel ARCUS® genome editing platform to eliminate the root cause of the disease.
