Bluejay Therapeutics Enrolls First Patient in AZURE-2 Global Phase 3 Clinical Trial Evaluating Brelovitug (BJT-778) Compared to Hepcludex® (Bulevirtide) for Chronic Hepatitis D
AZURE-2 evaluates the efficacy and safety of brelovitug as a monotherapy compared head-to-head with Hepcludex (bulevirtide)
Enrollment in AZURE-1, a global pivotal clinical trial evaluating the efficacy and safety of brelovitug compared to delayed treatment, continues on track
REDWOOD CITY, Calif., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Bluejay Therapeutics, Inc., a clinical-stage biopharmaceutical company dedicated to developing potentially life-changing therapeutics for serious viral and liver diseases, today announced that it has enrolled the first patient in its AZURE-2 global clinical trial evaluating brelovitug (also known as BJT-778) compared to Hepcludex® (bulevirtide) for the treatment of chronic hepatitis D (CHD). The phase 3 clinical trial is part of the global registrational program for brelovitug.
AZURE-2 is a randomized, controlled study evaluating brelovitug monotherapy (300 mg subcutaneous injection self-administered by participants weekly at home) compared with Hepcludex (bulevirtide) in adults with CHD. The primary endpoint is the proportion of participants who achieve a composite response at week 48, defined as undetectable hepatitis D virus RNA together with normalization of alanine aminotransferase (ALT). Elevated ALT levels are a marker of liver cell inflammation, which drives the development of liver cirrhosis and liver cancer.
“Chronic hepatitis D is the most severe form of viral hepatitis, yet it remains underserved, with limited or no approved treatment options in most countries,” said Nancy Shulman, M.D., Chief Medical Officer of Bluejay Therapeutics. “The primary endpoints of the AZURE-1 and AZURE-2 trials include a composite measure of viral response and ALT normalization. Evidence from large cohort studies in hepatitis B has shown an association between delayed ALT normalization and increased risk of liver disease progression and liver cancer.1”
“Bluejay continues to swiftly advance our registrational program for brelovitug in CHD,” said Keting Chu, M.D., Ph.D., Founder, Chief Executive Officer and Chairman of Bluejay Therapeutics. “We are proud to support the patients and providers in need of new hope.”
AZURE-1 (NCT06907290), which was initiated in March 2025, is enrolling in the United States and other countries around the world. The AZURE-1 trial is powered to detect superiority of brelovitug treatment compared with delayed treatment.
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 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. 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. Bluejay Therapeutics owns the worldwide rights to brelovitug.
About Chronic Hepatitis D (CHD)
CHD, a coinfection that occurs in some people infected with the hepatitis B virus, 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 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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Orangefiery
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1 https://pubmed.ncbi.nlm.nih.gov/31895708/
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