Bluejay Therapeutics has enrolled the first patient in AZURE-2, a global phase 3 clinical trial evaluating brelovitug (BJT-778) as a monotherapy for chronic hepatitis D (CHD). The study compares brelovitug with Hepcludex (bulevirtide) in adults with CHD.
AZURE-2 is a randomised, controlled trial assessing weekly self-administered subcutaneous injections of brelovitug. The primary endpoint is a composite response at week 48, defined as undetectable hepatitis D virus RNA and normalised alanine aminotransferase (ALT) levels.
ALT is a key marker of liver inflammation, which contributes to cirrhosis and liver cancer. The trial forms part of Bluejay’s global registrational programme for brelovitug.
Nancy Shulman, Chief Medical Officer of Bluejay Therapeutics, said: “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.”
She added: “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.”
Keting Chu, Founder and Chief Executive Officer of Bluejay Therapeutics, said: “Bluejay continues to swiftly advance our registrational program for brelovitug in CHD. We are proud to support the patients and providers in need of new hope.”
AZURE-1, a separate phase 3 trial comparing brelovitug with delayed treatment, began in March 2025 and is enrolling patients in the US and globally.
Brelovitug is a fully human monoclonal antibody targeting hepatitis B and D surface antigens. It has received Breakthrough Therapy designation from the FDA, and PRIME and Orphan status from the European Medicines Agency.
