A global phase I clinical study of PBGENE-HBV in chronic hepatitis B virus (HBV)
Latest Information Update: 21 Jun 2024
At a glance
- Drugs PBGENE-HBV (Primary)
- Indications Hepatitis B
- Focus Adverse reactions; First in man
- Sponsors Precision Biosciences
- 20 Jun 2024 According to a Precision Biosciences media release,anticipated Investigational New Drug (IND) and/or Clinical Trial Application (CTA) submission of PBGENE-HBV for the treatment of chronic hepatitis B in the second half of 2024.
- 13 May 2024 According to a Precision Biosciences media release, the company expects to submit an IND and/or CTA for this program in this year.
- 14 Feb 2024 According to a Precision Biosciences media release, the company had a pre-IND meeting with FDA in which it provided feedback on overall design of this trial as well as feedback on the toxicology and specificity assessments. The company is expanding site selection efforts with specialized centers focused on the treatment of Chronic Hepatitis B in several countries. Simultaneously, manufacturing is proceeding to supply drug for all planned nonclinical and clinical activities.