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

AZURE-1 will evaluate the efficacy and safety of brelovitug compared to delayed treatment

REDWOOD CITY, Calif., March 26, 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 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). 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).

“CHD is the most severe form of viral hepatitis with rapid progression to cirrhosis, liver failure and liver cancer. There are currently limited treatment options for CHD, with no therapy approved by the U.S. FDA,” said Nancy Shulman, M.D., Chief Medical Officer of Bluejay Therapeutics. “The initiation of our AZURE-1 pivotal clinical trial is a critical step toward addressing the unmet medical needs of people living with CHD. We plan to recruit and complete this trial as rapidly as possible.”

AZURE-1 is a global, randomized, controlled study of brelovitug as a monotherapy for adults living with CHD compared to delayed treatment. This study is being conducted in the United States and other countries around the world. The trial is powered to detect superiority of brelovitug treatment compared with delayed treatment.

“Dosing the first patient in AZURE-1 marks a significant milestone in our efforts to develop potentially life-changing treatments for people impacted by viral hepatitis,” said Keting Chu, M.D., Ph.D., Founder and Chief Executive Officer of Bluejay Therapeutics. “We are committed to advancing brelovitug toward regulatory approvals across the globe.”

Phase 2 data for brelovitug in CHD were presented at The Liver Meeting^® 2024 of the American Association for the Study of Liver Diseases (AASLD), demonstrating that brelovitug achieved 100% virologic response across all dose arms and up to 78% combined virologic response and ALT normalization as a monotherapy in participants with CHD. 

In January 2025, brelovitug received FDA Breakthrough Therapy designation for the treatment of CHD. It has also received PRIME and Orphan designations from the European Medicines Agency.

About Brelovitug (also known as 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 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. Bluejay Therapeutics owns the worldwide rights to brelovitug.

About Chronic Hepatitis D (CHD)
CHD is the most severe form of viral hepatitis due to the potential for rapid progression to liver cirrhosis, liver cancer and liver-related death. CHD affects approximately 7 million people globally. It is estimated that more than 50% of individuals with CHD will die of liver-related causes within 10 years of diagnosis. There are currently no approved treatments for CHD in the United States and most countries worldwide.

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 CHD and 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). For more information on Bluejay Therapeutics, please visit the company’s website at www.bluejaytx.com or follow the company on LinkedIn.

Media Contact: 
Dan Boyle 
Orangefiery 
media@orangefiery.com 
818-209-1692 

Investor Contact: 
Peter Garcia
CFO, Bluejay Therapeutics
ir@bluejaytx.com
650-674-2480