Gene editing company Precision BioSciences Inc (Nasdaq: DTIL) announced on Wednesday that it has received pre-Investigational New Drug (IND) regulatory feedback from the US FDA and ex-US agencies for its PBGENE-HBV program. The regulatory alignment supports Precision's clinical development path for PBGENE-HBV, designed to eliminate cccDNA and inactivate integrated HBV DNA. The company expects to file IND and/or CTA in 2024, with plans for a global clinical Phase 1 study.

The pre-IND meeting with the FDA provided feedback on the proposed first-in-human clinical study design, toxicology and specificity assessments. The alignment obtained from multiple regulatory authorities validates Precision's path towards the planned filing. PBGENE-HBV aims to be the first potentially curative gene editing program specifically targeting cccDNA and integrated HBV DNA.

Hepatitis B, a major global health concern, lacks curative options. PBGENE-HBV addresses this gap, offering a highly specific therapeutic approach to eliminate cccDNA and inactivate integrated HBV DNA. Precision BioSciences is expanding site selection efforts and progressing with manufacturing to support nonclinical and clinical activities.

ARCUS, Precision BioSciences' proprietary genome editing platform, utilises sequence-specific DNA-cutting enzymes to drive intended therapeutic outcomes. With over 130 granted patents, Precision's platform aims to deliver lasting cures for a broad range of genetic and infectious diseases.