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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 therapy being developed for the treatment of chronic hepatitis B. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in adult patients with chronic hepatitis B to evaluate its safety and antiviral activity.
PBGENE-HBV is being developed by Precision BioSciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol DTIL. The company is conducting a Phase 1 clinical trial to evaluate the safety and antiviral activity of PBGENE-HBV in adult patients with chronic hepatitis B.
PBGENE-HBV is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 study is recruiting participants to assess the safety and antiviral activity of PBGENE-HBV in adults with chronic hepatitis B.
PBGENE-HBV is being evaluated in a Phase 1 clinical trial registered as NCT06680232. This study is recruiting 45 adult patients with chronic hepatitis B across the United States, Hong Kong, Moldova, and New Zealand. The trial is uncontrolled, meaning there is no placebo or comparator group, and is designed to assess safety and antiviral activity.
PBGENE-HBV is a monoclonal antibody being studied for its potential antiviral activity against chronic hepatitis B. The specific molecular target of PBGENE-HBV has not been disclosed in the available clinical trial information. The ongoing Phase 1 study is designed to evaluate its safety and antiviral effects in adult patients.