Bluejay Therapeutics, a clinical-stage biopharmaceutical company, announced that its lead drug candidate, brelovitug (BJT-778), has received the breakthrough therapy designation from the US Food and Drug Administration (FDA).
Brelovitug targets chronic hepatitis delta (CHD), a serious viral liver disease.
According to Bluejay Therapeutics, there are no FDA-approved treatments for chronic hepatitis delta in the US or most countries.
Brelovitug has also received the orphan drug and PRIME designations from the European Medicines Agency.
In June last year, Bluejay Therapeutics announced positive preliminary data for brelovitug from its Phase 2 clinical trial. In November 2024, Bluejay Therapeutics reported new data from the mid-stage study.
The breakthrough status will accelerate the drug candidate’s development and review. The designation is intended for therapies that show promising early clinical evidence and potential to improve upon existing treatments.
Bluejay Therapeutics founder and CEO Keting Chu said: “Chronic hepatitis delta is the most aggressive form of viral hepatitis and the lack of approved treatments in the US creates a major unmet need for patients.
“Breakthrough Therapy designation recognises the potential of brelovitug to transform the lives of people living with CHD. We look forward to initiating a global pivotal trial as soon as possible to meet our goal of improving patients’ lives.”
Brelovitug is a high-potency, fully human IgG1 monoclonal antibody that targets the hepatitis B surface antigen (HBsAg).
It is designed to neutralise and remove hepatitis B and D virions while depleting HBsAg-containing subviral particles.
This makes brelovitug a potentially safe and effective treatment for chronic hepatitis delta, a condition with significant unmet medical need.
Additionally, the drug candidate has shown immunomodulatory effects in chronic hepatitis B (CHB) patients, potentially reconstituting antiviral immunity and aiding in a functional cure when combined with other treatments.
Bluejay Therapeutics is also advancing several other programmes aimed at developing a combination regimen for a functional cure of chronic hepatitis B. These include a proprietary TLR9 agonist, cavrotolimod, and a liver-targeted hepatitis B virus (HBV) transcript inhibitor, BJT-628.
