brelovitug (BJT-778) / Mirum Pharmaceuticals - LARVOL DELTA

A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4) (clinicaltrials.gov) - P3 | N=80 | Active, not recruiting | Sponsor: Mirum Pharmaceuticals, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Inflammation

Safety, pharmacokinetics, pharmacodynamics, and antiviral activity of cavrotolimod, alone and in combination with low-dose nivolumab, for the treatment of chronic hepatitis B (EASL 2026) - "Study BJT-008-001 is an ongoing Ph1b/2 study evaluating cavrotolimod ± nivolumab ± brelovitug (mAb against HBsAg) in subjects with CHB. Multiple doses of cavrotolimod x 4 weeks ±1 dose nivolumab were generally well tolerated in CHB subjects. Most subjects experienced mild-to-moderate ISRs that were not treatment-limiting. Cavrotolimod elicited a potent immune response with strong cytokine/chemokine production and augmented HBV-specific T cell responses."

Clinical • Combination therapy • PK/PD data • Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Inflammation • CD4 • CD8 • CXCL10 • IFNG • IL15

24-week safety and efficacy of brelovitug monotherapy for the treatment of chronic hepatitis D: data from phase 2b of AZURE-1 (EASL 2026) - "In individuals with CHD with and without cirrhosis, brelovitug was associated with early improvements in HDV RNA, ALT and was well-tolerated. Multiple Phase 3 trials are ongoing."

Clinical • Late-breaking abstract • Monotherapy • P2b data • Cardiovascular • Fibrosis • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Portal Hypertension

Reported brelovitug Phase 2b portion of AZURE-1 study in chronic hepatitis delta virus (HDV) met primary endpoint; full results to be presented in a late-breaking poster presentation at the EASL Congress on May 27 starting at 8:30 a.m. CEST. (Businesswire) - "Completed enrollment in brelovitug AZURE-1 and AZURE-4 Phase 3 studies in HDV; topline results expected in H2 2026."

Enrollment closed • P2b data • Infectious Disease

A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4) (clinicaltrials.gov) - P3 | N=80 | Recruiting | Sponsor: Mirum Pharmaceuticals, Inc. | Active, not recruiting ➔ Recruiting | N=35 ➔ 80

Enrollment change • Enrollment open • Trial initiation date • Infectious Disease • Inflammation

A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4) (clinicaltrials.gov) - P3 | N=31 | Active, not recruiting | Sponsor: Mirum Pharmaceuticals, Inc. | Recruiting ➔ Active, not recruiting | N=17 ➔ 31

Enrollment change • Enrollment closed • Infectious Disease • Inflammation

A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4) (clinicaltrials.gov) - P3 | N=31 | Active, not recruiting | Sponsor: Mirum Pharmaceuticals, Inc.

New P3 trial • Infectious Disease • Inflammation

A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4) (clinicaltrials.gov) - P3 | N=35 | Active, not recruiting | Sponsor: Mirum Pharmaceuticals, Inc.

New P3 trial • Infectious Disease • Inflammation

Phase 2b/3 Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide (clinicaltrials.gov) - P2/3 | N=120 | Recruiting | Sponsor: Mirum Pharmaceuticals, Inc.

New P2/3 trial • Infectious Disease • Inflammation

BJT-778-303: Phase 2b/3 Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide (clinicaltrialsregister.eu) - P2/3 | N=115 | Not yet recruiting | Sponsor: Bluejay Therapeutics Inc.

New P2/3 trial • Infectious Disease • Inflammation

BJT-778-303: Phase 2b/3 Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide (clinicaltrialsregister.eu) - P2/3 | N=115 | Recruiting | Sponsor: Bluejay Therapeutics Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Inflammation

BJT-778-304: Phase 3 Study to Evaluate Brelovitug vs Delayed Treatment for Treatment of Chronic Hepatitis Delta Infection (AZURE-4) (clinicaltrialsregister.eu) - P2/3 | N=17 | Recruiting | Sponsor: Bluejay Therapeutics Inc.

New P2/3 trial • 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 | Active, not recruiting | Sponsor: Bluejay Therapeutics, Inc. | Trial completion date: Jun 2028 ➔ Sep 2029 | Trial primary completion date: Jun 2027 ➔ May 2029 | Recruiting ➔ Active, not recruiting

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Inflammation

A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4) (clinicaltrials.gov) - P3 | N=80 | Recruiting | Sponsor: Bluejay Therapeutics, Inc.

New P3 trial • Infectious Disease • Inflammation

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