FDA Places Arbutus’ Chronic Hepatitis B Virus IND Candidate Under Clinical Hold

Arbutus Biopharma’s AB-101 IND application to treat chronic hepatitis B virus (HBV) has been placed under an FDA clinical hold.

AB-101 is an oral PD-L1 inhibitor candidate intended to boost the immune system of patients by activating and reinvigorating specific T-cells and could, in combination with other drugs, “potentially lead to a functional cure in HBV,” the company said.

The agency communicated the news to the company verbally and will provide a letter to Arbutus within 30 days.

The investigational drug phase 1 single-ascending dose portion initial data will no longer be reported in the second half of 2023, the company said.

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