brelovitug (BJT-778) / Bluejay Therap - LARVOL DELTA

IMMUNE COMPLEXES OF BJT-778 ENHANCE CROSS-PRESENTATION OF HBSAG AND ACTIVATION OF CD8+ T CELLS (AASLD 2025) - "BJT-778 not only enhances the uptake of HBsAg by antigen-presenting cells but also facilitates efficient cross-presentation to CD8+ T cells. These findings expand the mechanistic understanding of BJT-778 beyond CD4+ T cell activation, demonstrating its ability to boost HBV-specific CD8+ T cell responses. Together, the data support combining BJT-778 with immunomodulators to enhance both HBV-specific CD4 and CD8 T cell immunity."

Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Inflammation • CD14 • CD40LG • CD8 • HLA-A • IFNG

BRELOVITUG (BJT-778) BINDS A CONFORMATIONAL EPITOPE HIGHLY CONSERVED ACROSS HBV GENOTYPES (AASLD 2025) - "HBsAg residues I/L110, G119, Q/H129, S/A132, P142, T/L/S143, D/E144, G145, I150, P151 and I152 are critical for brelovitug binding. These amino acids are highly conserved (≥98.2%) among HBsAg from HBV genotypes A – H consistent with brelovitug's pan-genotypic neutralization activity in vitro. Therefore, brelovitug binds to a highly conserved epitope comprised of these residues, reinforcing its potential as a broadly effective therapeutic for chronic hepatitis B and D."

Hepatitis B • Hepatology • Infectious Disease • Inflammation

BRELOVITUG (BJT-778) MONOTHERAPY ACHIEVED 100% VIROLOGIC RESPONSE IN PATIENTS WITH CHRONIC HEPATITIS D (CHD): ON TREATMENT WEEK 48 PHASE 2 STUDY RESULTS (AASLD 2025) - "All brelovitug regimens explored achieved 100% virologic response with a combined response rate of 64%-82% at the interim Week 48 analysis. All dosing regimens have been safe and well-tolerated. Phase 3 trials are underway."

Clinical • Monotherapy • P2 data • Fibrosis • Hepatology • Immunology • Inflammation

A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2) (clinicaltrials.gov) - P3 | N=172 | Recruiting | Sponsor: Bluejay Therapeutics, Inc.

New P3 trial • Infectious Disease • Inflammation

An optional multicenter, open-label Phase 2a multiple dose study in Chronic Hepatitis B (CHB) subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BJT-778 (ANZCTR) - P2 | N=24 | Active, not recruiting | Sponsor: Bluejay Therapeutics Inc. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (clinicaltrials.gov) - P2/3 | N=150 | Recruiting | Sponsor: Bluejay Therapeutics, Inc.

New P2/3 trial • Hepatology • Infectious Disease • Inflammation

Bluejay Therapeutics Announces First Patient Dosed in AZURE-1 Global Pivotal Clinical Trial Evaluating Brelovitug (BJT-778) as a Monotherapy Treatment for Chronic Hepatitis D (GlobeNewswire) - "Bluejay Therapeutics...today announced that the first patient has been dosed in its AZURE-1 global pivotal clinical trial evaluating brelovitug (also known as BJT-778) for the treatment of chronic hepatitis D (CHD)."

Trial status • Hepatitis B

Bluejay Therapeutics Receives U.S. FDA Breakthrough Therapy Designation for Brelovitug (BJT-778) for the Treatment of Chronic Hepatitis Delta (GlobeNewswire) - "Bluejay Therapeutics...today announced that its lead product candidate brelovitug (also known as BJT-778) has received U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation for the treatment of chronic hepatitis delta (CHD). There are currently no approved treatments for chronic hepatitis D in the United States and most countries around the world."

Breakthrough therapy • Infectious Disease

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BJT-778 in Subjects with Chronic HBV Infection (CHB) and Chronic HDV Infection (CHD). (ANZCTR) - P1/2 | N=72 | Recruiting | Sponsor: Bluejay Therapeutics Inc. | N=32 ➔ 72

Enrollment change • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of BJT-778 in Subjects with Chronic HBV Infection (CHB). (ANZCTR) - P1 | N=40 | Completed | Sponsor: Bluejay Therapeutics Inc. | Recruiting ➔ Completed

Trial completion • Hepatitis B • Hepatology • Infectious Disease • Inflammation

BJT-778, ANTI-HBSAG MONOCLONAL ANTIBODY, ACHIEVED 100% VIROLOGIC RESPONSE IN SUBJECTS WITH CHRONIC HEPATITIS D (CHD): PHASE 2 STUDY RESULTS (AASLD 2024) - "Monotherapy with BJT-778 ≤900mg has been safe and well-tolerated. BJT-778 300mg QW achieved 100% virologic response and a decline in ALT in all subjects with CHD, with a combined response of 67% by Week 28. These promising results warrant further development of BJT-778 for chronic HDV."

Clinical • P2 data • Fibrosis • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation

UPTAKE AND T CELL STIMULATION BY BJT-778-HBSAG IMMUNE COMPLEXES: INSIGHTS INTO ANTI-HBS MONOCLONAL ANTIBODY FUNCTION (AASLD 2024) - "These data identify the likely in vivo targets of BJT-778-HBsAg ICs and demonstrate that BJT-778 ICs lead to enhanced HBsAg uptake in professional antigen presenting cells. Enhanced uptake of HBsAg resulted in increased HBV-specific CD4 T cell activation, supporting a dual mechanism of action through removal of circulating HBsAg and stimulation of HBV-specific T cell immunity."

Hepatitis B • Hepatology • Infectious Disease • Inflammation • CD14 • IFNG

Characterization of BJT-778, an anti-HBsAg neutralizing monoclonal antibody for treatment of hepatitis B virus and hepatitis D virus infections (EASL-ILC 2024) - "BJT-778 is a potent, selective, fully human IgG1-neutralizing mAb that can neutralize HBV and HDV infections in vitro and clear HBsAg-containing particles from serum in a humanized mouse model. BJT-778 is currently undergoing clinical evaluation in subjects with CHB and CHD infections."

Fibrosis • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Infectious Disease • Inflammation • Liver Failure • Oncology • Solid Tumor

Rapid reductions of HDV RNA and ALT with the monoclonal antibody, BJT-778: results from a phase 2 study (EASL-ILC 2024) - "Monotherapy with BJT-778 was safe and well-tolerated and achieved rapid virologic responses with ALT normalization in most subjects with CHD. Comprehensive data from all study arms will be presented, offering further insights into the therapeutic potential of BJT-778."

Late-breaking abstract • P2 data • Fibrosis • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

Uptake and T cell stimulation by anti-HBs monoclonal antibody BJT-778-rHBsAg immune complexes (EASL-ILC 2024) - "These data identify the likely in vivo targets of BJT-778-HBsAg ICs and demonstrate that BJT-778 ICs lead to enhanced HBsAg uptake in professional antigen presenting cells. Enhanced uptake of HBsAg resulted in increased HBV-specific CD4 T cell activation, supporting a dual mechanism of action through removal of circulating HBsAg and stimulation of HBV-specific T cell immunity."

Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation • CD14 • IFNG

Characterization of BJT-778, an anti-HBsAg neutralizing monoclonal antibody for treatment of hepatitis B virus and hepatitis D virus infections (EASL-ILC 2024) - "BJT-778 is a potent, selective, fully human IgG1-neutralizing mAb that can neutralize HBV and HDV infections in vitro and clear HBsAg-containing particles from serum in a humanized mouse model. BJT-778 is currently undergoing clinical evaluation in subjects with CHB and CHD infections."

Fibrosis • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Infectious Disease • Inflammation • Liver Failure • Oncology • Solid Tumor

Safety, tolerability, and pharmacokinetics of BJT-778, a monoclonal antibody for treatment of chronic hepatitis B and chronic hepatitis D, following single ascending doses in healthy volunteers (EASL-ILC 2024) - "The PK of BJT-778 administered subcutaneously increased dose-proportionally up to the highest dose, 900 mg. The long half-life and sustained plasma concentration surpassing the EC 50 support the convenient clinical dosing schedules and suggest that dose levels are within the therapeutic range, respectively. All doses were safe and well tolerated."

Clinical • PK/PD data • Fatigue • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Bluejay Therapeutics Receives Positive Opinion on Orphan Designation from the European Medicines Agency for BJT-778 for the Treatment of Chronic Hepatitis D (GlobeNewswire) - "Bluejay Therapeutics...announced that the European Medicines Agency (EMA) has issued a positive opinion on the Company’s application for orphan designation for BJT-778 for the treatment of chronic hepatitis D (CHD)....In addition to orphan designation, BJT-778 has also been granted Priority Medicines (PRIME) designation by the EMA for the treatment of chronic HDV, an endorsement to the therapy’s potential to address a high unmet need in patients with these serious conditions."

Orphan drug • Priority review • Infectious Disease

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BJT-778 in Healthy Volunteers. (ANZCTR) - P1 | N=32 | Completed | Sponsor: Bluejay Therapeutics Inc | Not yet recruiting ➔ Completed

Trial completion • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BJT-778 in Subjects with Chronic HBV Infection (CHB) and Chronic HDV Infection (CHD). (ANZCTR) - P1/2 | N=32 | Recruiting | Sponsor: Bluejay Therapeutics Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Trial initiation date • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of BJT-778 in Subjects with Chronic HBV Infection (CHB). (ANZCTR) - P1 | N=40 | Recruiting | Sponsor: Bluejay Therapeutics Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Trial initiation date • Hepatitis B • Hepatology • Infectious Disease • Inflammation