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 (<LLOQ [HDV RNA 10 IU/mL]) and 44% with undetectable HDV RNA (<LLOQ, TND);
- 600 mg QW/Q2W (n=10): 100% virologic response, including 70% <LLOQ and 30% <LLOQ, TND; and
- 900 mg Q4W (n=18): 100% virologic response, including 78% <LLOQ and 39% <LLOQ, TND.
Up to 82% of participants reached the combined endpoint of virologic response and ALT normalization. By dose, the results were as follows:
- 300 mg QW (n=11/17): 65%
- 600 mg QW/Q2W (n=3/4): 75%
- 900 mg Q4W (n=14/17): 82%
Brelovitug was well tolerated at all doses, with no ≥ grade 3 Adverse Events (AEs), no severe AEs and no treatment discontinuations due to AEs.
“We are encouraged by these results and pleased to be actively enrolling patients in the AZURE global Phase 3 clinical trial program evaluating brelovitug in a larger patient population, which is on track,” said Nancy Shulman, MD, Chief Medical Officer of Bluejay Therapeutics. “We are moving forward rapidly with hepatitis D patients in mind, as they are in urgent need of new treatment options.”
Details for the oral presentation of these data are as follows:
Title: Brelovitug (BJT-778) Monotherapy Achieved 100% Virologic Response in Patients with Chronic Hepatitis D (CHD): On Treatment Week 48 Phase 2 Study Results
Presentation number: 0009
Session: Clinical Plenary #2
Date: Monday, November 10
Time: 8:30 am-8:45 am ET
Presenter: Kosh Agarwal, BMed Sci (Hons) M.D., FRCP, Institute of Liver Studies, King’s College Hospital, London, UK
New Brelovitug (BJT-778) Preclinical Data
In addition to being investigated as a monotherapy for CHD, brelovitug is being studied as part of a combination strategy aimed at achieving functional cure for chronic hepatitis B (CHB). Brelovitug has multiple mechanisms of action, including neutralizing infectious hepatitis D and hepatitis B virus by binding to surface antigens, clearing HBsAg-containing particles and activating antigen-specific T cells. Researchers have shown that brelovitug forms immune complexes (ICs) with HBsAgs that enhance antigen uptake. The uptake of these ICs by monocytes enhances HBsAg-Specific CD4+ T cell activation, while differentiation of IC-loaded monocytes to dendritic cells enhances antigen cross-presentation to HBsAg-Specific CD8+ T cells.
Posters presented on Friday, November 7 at The Liver Meeting discussed brelovitug’s immune system impact and pan-genotypic response to HBsAg variants. The poster presentation details are as follows:
Title: Brelovitug (BJT-778) Binds a Conformational Epitope Highly Conserved Across HBV Genotypes
Presentation number: 1207
Presenter: Craig Pace, PhD
Title: Immune Complexes of BJT-778 Enhance Cross-Presentation of HBsAg and Activation of CD8+ T Cells
Presentation number: 1312
Presenter: Adam J. Gehring, PhD
About Brelovitug (BJT-778)
Brelovitug is an investigational, highly potent, pan-genotypic, fully human immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets the surface antigen (anti-HBsAg) on both the hepatitis D virus (HDV) and the hepatitis B virus (HBV). Brelovitug is designed to neutralize and remove hepatitis B and hepatitis D virions and deplete HBsAg-containing subviral particles, which gives brelovitug a potentially advantageous safety profile and makes it a potentially efficacious treatment for chronic hepatitis D (CHD), a condition with urgent unmet medical need. In addition, brelovitug has shown immunomodulatory functions in chronic hepatitis B (CHB) patients, which may help to reconstitute antiviral immunity and contribute to functional cure for CHB when combined with other agents. Brelovitug has FDA Breakthrough Therapy designation for the treatment of CHD and PRIME and Orphan designations from the European Medicines Agency. Bluejay Therapeutics owns the worldwide rights to brelovitug.
About Bluejay Therapeutics
Bluejay Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing potentially life-changing therapeutics for serious viral and liver diseases. The company is currently investigating brelovitug for the treatment of chronic hepatitis D (CHD) and chronic hepatitis B (CHB) viral infections. Additionally, Bluejay is advancing several innovative programs with the goal of developing a combination regimen to achieve a functional cure for chronic hepatitis B, including a proprietary TLR9 agonist (cavrotolimod) and a liver-targeted HBV transcript inhibitor (BJT-628). The company is also investigating BJT-188, a preclinical liver-targeted fatty acid synthase (FASN) inhibitor, for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). For more information on Bluejay Therapeutics, please visit the company’s website at www.bluejaytx.com or follow the company on LinkedIn.
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