Bluejay Therapeutics Receives FDA Breakthrough Designation for Chronic Hepatitis Delta
Bluejay Therapeutics, a clinical-stage biopharmaceutical company focused on developing potential treatments for serious viral and liver diseases, has announced that its lead product candidate, brelovitug (also known as BJT-778), has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of chronic hepatitis delta (CHD).
CHD is considered the most severe form of viral hepatitis, and the absence of approved treatments in the U.S. highlights a significant unmet medical need for patients.
The Breakthrough Therapy designation recognises the potential of brelovitug to transform the lives of individuals living with this condition.
Brelovitug is a highly potent, fully human IgG1 monoclonal antibody (mAb) targeting the hepatitis B virus surface antigen (anti-HBsAg).
Designed to neutralise and remove hepatitis B and D virions, it also depletes subviral particles containing HBsAg, positioning brelovitug as a potentially safe and highly effective treatment for CHD.
Furthermore, brelovitug has demonstrated immunomodulatory effects in chronic hepatitis B (CHB) patients, which may help restore antiviral immunity and support a functional cure for CHB when used alongside other treatments.
Bluejay Therapeutics aims to begin a global pivotal trial as soon as possible to achieve its goal of improving patient outcomes.
The FDA’s Breakthrough Therapy designation is granted to investigational treatments that show promising early clinical evidence for serious conditions and offer potential advantages over current treatment options.
