Words by GOLD newsdesk
Bluejay Therapeutics, a clinical-stage biopharmaceutical company focused on viral and liver diseases, announced today that its lead candidate, brelovitug, has been granted Breakthrough Therapy designation by the FDA for the treatment of chronic hepatitis delta (CHD).
CHD occurs when a person is infected with both hepatitis B (HBV) and hepatitis D (HDV). Currently, there are no approved treatments for the disease in the US and most other countries, highlighting the need for a new treatment.
“Chronic hepatitis delta is the most aggressive form of viral hepatitis,” said Keting Chu, Founder and CEO, Bluejay Therapeutics. “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.”
With the FDA’s Breakthrough Therapy designation, brelovitug will benefit from an expedited development process, bringing it closer to patients who need a therapeutic option. The treatment, which works by neutralising both hepatitis B and D viruses, could significantly improve outcomes for patients living with this dual infection.
Brelovitug has previously received Orphan Drug and PRIME designations from the European Medicines Agency, further underlining its potential. Bluejay Therapeutics is also investigating a range of other treatments aimed at achieving a functional cure for chronic hepatitis B, including a TLR9 agonist and virus transcript inhibitor.
