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PBGENE-HBV · 1 trial · 1 indication
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| 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 therapy being studied for the treatment of chronic hepatitis B. It is designed to target HBV cccDNA and integrated HBV DNA, which are key components of the hepatitis B virus life cycle. The drug is currently in Phase 1 clinical development.
PBGENE-HBV targets HBV cccDNA and integrated HBV DNA. These are forms of the hepatitis B virus genome that persist in infected liver cells and are difficult to eliminate with standard antiviral therapies. By targeting these elements, PBGENE-HBV aims to address the underlying cause of chronic infection.
PBGENE-HBV is being developed by Precision BioSciences, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol DTIL. Precision BioSciences is conducting clinical trials to evaluate the safety and antiviral activity of PBGENE-HBV in patients with chronic hepatitis B.
PBGENE-HBV is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is designed to evaluate the safety and antiviral activity of PBGENE-HBV in adult patients with chronic hepatitis B.
PBGENE-HBV is being studied in a Phase 1 clinical trial with the identifier NCT06680232. This trial is recruiting participants and aims to enroll approximately 45 adult patients with chronic hepatitis B. The study is being conducted at multiple sites across the United States, France, Hong Kong, Moldova, New Zealand, and Romania.