Bluejay Therapeutics Begins Dosing in AZURE-1 Trial for Brelovitug as a Monotherapy for Chronic Hepatitis D

On March 26, 2025, Bluejay Therapeutics, based in Redwood City, California, announced the commencement of dosing for the first patient in its AZURE-1 global pivotal clinical trial. This trial is designed to evaluate brelovitug, also known as BJT-778, as a treatment for chronic hepatitis D (CHD). Bluejay Therapeutics is a clinical-stage biopharmaceutical firm focused on developing promising treatments for severe viral and liver diseases.

Brelovitug is an investigational, highly potent monoclonal antibody targeting the surface antigen on both the hepatitis D virus (HDV) and the hepatitis B virus (HBV). Chronic hepatitis D is acknowledged as the most severe form of viral hepatitis, frequently progressing rapidly to conditions such as cirrhosis, liver failure, and liver cancer. Currently, there are limited therapeutic options for CHD, with no treatment approved by the U.S. Food and Drug Administration (FDA).

Dr. Nancy Shulman, the Chief Medical Officer at Bluejay Therapeutics, emphasized the importance of the AZURE-1 trial in addressing the unmet medical needs of individuals suffering from CHD. The study is a critical phase in advancing potential treatments for CHD. The global, randomized, controlled study will compare brelovitug as a monotherapy to delayed treatment in adults living with CHD. Conducted in the United States and internationally, the trial is designed to evaluate the superiority of brelovitug over delayed treatment.

Dr. Keting Chu, Founder and CEO of Bluejay Therapeutics, highlighted that initiating patient dosing in AZURE-1 is a significant milestone in the pursuit of novel treatments for viral hepatitis patients. The company is dedicated to advancing brelovitug toward obtaining regulatory approvals worldwide. In earlier phases, brelovitug demonstrated impressive results, showing a 100% virologic response across all doses and achieving up to 78% combined virologic response and ALT normalization as a monotherapy in CHD patients.

The promising results led to brelovitug receiving FDA Breakthrough Therapy designation in January 2025. It has also been granted PRIME and Orphan designations by the European Medicines Agency. These designations highlight the drug's potential to address significant unmet needs in treating CHD.

Brelovitug is crafted to neutralize and eliminate hepatitis B and D virions while depleting subviral particles containing the surface antigen, which potentially enhances its safety profile and efficacy as a CHD treatment. Additionally, brelovitug has demonstrated immunomodulatory functions in chronic hepatitis B patients, potentially aiding in restoring antiviral immunity and contributing to a functional cure for CHB when used alongside other treatments. Bluejay Therapeutics holds the worldwide rights to brelovitug.

Chronic hepatitis D impacts approximately 7 million individuals globally and often leads to severe outcomes such as liver cirrhosis, cancer, and liver-related death. Without approved treatments in most places, including the United States, CHD poses a significant health challenge. It is estimated that over half of CHD patients may succumb to liver-related causes within a decade of diagnosis.

Bluejay Therapeutics aims to develop transformative treatments for serious viral and liver diseases. The company is actively investigating brelovitug for CHD and CHB viral infections and pursuing innovative programs to achieve a functional cure for chronic hepatitis B. Their efforts include the development of a proprietary TLR9 agonist and a liver-targeted HBV transcript inhibitor.