Bluejay Shows Promising Phase 2 BJT-778 Results for Hepatitis D at EASL 2024

Bluejay Therapeutics has unveiled promising early results from a Phase 2 study of BJT-778, a fully human IgG1 monoclonal antibody targeting hepatitis B surface antigen (anti-HBsAg mAb), in patients with chronic hepatitis D (CHD). These findings were presented at the European Association for the Study of the Liver (EASL) Congress 2024.

In the first treatment arm of the study, all patients achieved a virologic response by Week 28 while being treated with BJT-778. This virologic response is defined as either a reduction of at least 2 log in hepatitis D virus (HDV) RNA levels or the RNA becoming undetectable. Notably, all patients in this group showed reductions in alanine aminotransferase (ALT) levels, a key marker of liver inflammation, with two-thirds achieving normalization of ALT, indicating a positive impact on liver health. These outcomes suggest that BJT-778 could be a viable monotherapy for CHD.

Dr. Keting Chu, Founder and CEO of Bluejay, expressed optimism about these initial findings. He highlighted the potential of BJT-778 to meet the significant unmet needs of the millions globally affected by chronic hepatitis D.

The Phase 2 study has enrolled 31 patients as of late May 2024. These participants are divided into three arms: 
- Arm 1 (n=10): Patients receive 300 mg of BJT-778 subcutaneously (SC) once a week for 48 weeks.
- Arm 2 (n=11): Patients receive 600 mg SC weekly for 12 weeks, followed by a biweekly dose for the remaining 36 weeks.
- Arm 3 (n=10): Patients receive 900 mg SC every two weeks for 4 weeks, followed by a monthly dose for 44 weeks.

Participants in Arm 1 have completed at least 24 weeks of treatment, while those in Arm 2 have reached 12 weeks. Arm 3 has fewer than 4 weeks of data available. The study's endpoints include safety and tolerability, changes in HDV RNA and ALT levels from baseline, and the proportion of subjects achieving virologic response, ALT normalization, and a composite response (both virologic response and ALT normalization).

Key findings from the study are as follows:

Preliminary Efficacy
- Arm 1: All 10 patients (100%) achieved a virologic response by Week 28. ALT levels decreased in all participants, with 67% (6 out of 9) achieving normalization. One participant had a normal ALT at the start, which continued to decline. The composite response rate was 67%, with the mean reduction in HDV RNA being 3.6 logs at Week 24.
- Arm 2: By Week 12, 80% of the patients (8 out of 10) achieved a virologic response. ALT levels decreased in most patients, including those with initially normal ALT levels. Of the four patients with abnormal ALT at baseline, three achieved normalization by Week 12.

Preliminary Safety
BJT-778 was well tolerated across all three treatment arms, with doses up to 900 mg. There were no reports of serious or Grade 3/4 adverse events, and no patients discontinued due to adverse events.

About BJT-778
BJT-778 is a potent, fully human IgG1 monoclonal antibody that neutralizes and clears hepatitis B and D virions. It also depletes subviral particles containing HBsAg, potentially aiding in reconstituting antiviral immunity and contributing to a functional cure for chronic hepatitis B (CHB). The European Medicines Agency (EMA) has granted BJT-778 orphan and PRIME designations based on promising Phase 1/2 study results.

About Bluejay Therapeutics
Bluejay Therapeutics is focused on developing treatments for viral and liver diseases. Alongside BJT-778, the company is advancing other innovative programs targeting chronic HBV, such as a proprietary TLR9 agonist (Cavrotolimod) and a liver-targeted transcript inhibitor (BJT-628), aiming to achieve functional cures through combination therapies.

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