Bluejay Therapeutics’ Brelovitug (BJT-778) Monotherapy Achieved 100% Virologic Response and up to 82% Combined Endpoint of Virologic Response and ALT Normalization at Week 48 in Phase 2 Study in Chronic Hepatitis D (CHD)

All brelovitug dose regimens studied were well tolerated

Results will be presented at The Liver Meeting® 2025 of AASLD

Additional preclinical data presented on brelovitug mechanisms of action

REDWOOD CITY, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Bluejay Therapeutics, a clinical-stage biopharmaceutical company dedicated to developing potentially life-changing therapeutics for serious viral and liver diseases, today announced Week 48 treatment data in chronic hepatitis D (CHD) for brelovitug (BJT-778), an investigational, fully human, high-affinity monoclonal antibody (mAb) that targets hepatitis B virus surface antigen (anti-HBsAg). These data will be presented today, Nov. 10, at 8:30am ET in the session Clinical Plenary #2 at The Liver Meeting® 2025 of the American Association for the Study of Liver Diseases (AASLD) in Washington, DC.

In this Phase 2 study, brelovitug achieved 100% virologic response across all dose arms and up to 82% of participants reached the combined endpoint of virologic response and ALT normalization. Parallel declines in hepatitis D virus (HDV) viral load and ALT were observed across all doses, indicating a beneficial effect on liver inflammation in addition to viral load reduction.

“New therapies are urgently needed to address individuals living with hepatitis D,” said presenting author of the study Kosh Agarwal, BMed Sci (Hons) MD, FRCP, Consultant Hepatologist and Transplant Physician of the Institute of Liver Studies at King’s College Hospital in London, United Kingdom. “The combined virologic and ALT normalization rates achieved with brelovitug monotherapy are promising. We look forward to the continued assessment of brelovitug in Bluejay’s AZURE global Phase 3 clinical program.”

CHD, a co-infection occurring in patients with chronic hepatitis B (CHB), is the most aggressive form of viral hepatitis. Individuals coinfected with CHD and CHB have twice the risk of liver cancer and three times the risk of cirrhosis compared to those with CHB alone. There are currently no approved treatments for CHD in the United States and most countries worldwide.

Brelovitug CHD Phase 2 Week 48 Study Results

Participants with quantifiable HDV RNA and hepatitis B virus suppressed on nucleos(t)ides were assigned to one of three brelovitug dosing regimens: 300 mg weekly (QW) (n=18); 600 mg every week for 12 weeks, then every two weeks (Q2W) (n=11); and 900 mg every four weeks (Q4W) with a loading dose administered at week two (n=18). Participants with compensated cirrhosis and those with well-controlled HIV were eligible for inclusion.

Key endpoints of the study include safety and tolerability; virologic response (defined as ≥2 log10 HDV RNA IU/mL reduction from baseline or HDV RNA target not detected (TND)); ALT normalization in those participants with abnormal ALT at baseline; and the combined response of virologic response plus ALT normalization. According to FDA guidance, this combined endpoint is a reliable predictor of clinical benefit and directly supports approval of new drugs in CHD.

Brelovitug achieved 100% virologic response across all dose arms. The Week 48 results for each dose were as follows:

300 mg QW (n=18): 100% virologic response, including 56% with HDV RNA below the Lower Limit of Quantification (