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PBGENE-HBV · 1 trial · 1 indication
Frequency of TEAEs
| Arm | Type | Description |
|---|---|---|
| Participants in both Part 1 and 2 will receive a finite course of PBGENE-HBV. | EXPERIMENTAL | All participants will receive a finite course of multiple IV dose administrations of PBGENE-HBV. In Part 1, this will be done in a dose escalation manner which may be evaluated further in a Part 2 expansion cohort. |
| Name | Type | Description |
|---|---|---|
| PBGENE-HBV | BIOLOGICAL | PBGENE-HBV is an in vivo gene editing intervention based on a novel proprietary ARCUS® platform designed to potentially cure chronic hepatitis B virus (HBV) by eliminating cccDNA, the key source of replicating hepatitis B virus, while also inactivating integrated HBV DNA in hepatocytes. |
Key Inclusion Criteria: * Male or women of non-child bearing potential * BMI 18.0 to 35.0 * Good overall health deemed by the study Investigator * CHB infection documented at least 12 months prior to screening * HBeAg-negative CHB * Must be virologically suppressed on current NA treatment Key Excl...
PBGENE-HBV is an investigational gene editing therapy being developed by Precision BioSciences, Inc. for chronic hepatitis B. It is designed to target HBV cccDNA and integrated HBV DNA. It is currently in Phase 1 clinical development and has received FDA Fast Track designation.
PBGENE-HBV is being developed for the treatment of chronic hepatitis B, a persistent viral infection of the liver. The Phase 1 study enrolls adult patients with chronic hepatitis B. It is investigational and has not been approved for any indication.
PBGENE-HBV targets HBV cccDNA and integrated HBV DNA. By acting on these viral DNA forms, the therapy is intended to address the underlying sources of hepatitis B viral persistence rather than only suppressing viral replication.
PBGENE-HBV is being developed by Precision BioSciences, Inc., which trades on the Nasdaq under the ticker DTIL. The company is the sponsor of the ongoing Phase 1 clinical study of the candidate in chronic hepatitis B.
PBGENE-HBV is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The FDA has granted PBGENE-HBV Fast Track designation for its development in chronic hepatitis B.
PBGENE-HBV is being studied in one active Phase 1 trial, NCT06680232, titled a Phase 1 study to evaluate safety and antiviral activity of PBGENE-HBV in adult patients with chronic hepatitis B. The trial is recruiting up to 45 participants across the United States, France, Hong Kong, Moldova, New Zealand, and Romania.