Positive preliminary BJT-778 data from Phase II trial in chronic hepatitis D

Privately-held US biotech Bluejay Therapeutics today announced positive preliminary data from the Phase II study of BJT-778, at the European Association for the Study of the Liver (EASL) Congress 2024.

BIT-778 is a fully human IgG1 monoclonal antibody that acts against hepatitis B surface antigen (anti-HBsAg mAb), in patients with chronic hepatitis D (CHD).

In the first test arm, 100% of treated patients achieved a virologic response (at least a 2 log reduction in hepatitis D virus (HDV) RNA or becoming HDV RNA undetectable) by Week 28 while receiving treatment with BJT-778. All subjects had reductions of alanine aminotransferase (ALT) from baseline, including two-thirds of subjects whose ALT became normal, reflecting a beneficial effect on liver inflammation. These results highlight the potential of BJT-778 as a monotherapy treatment for CHD.