Privately-held US biopharma Bluejay Therapeutics has announced that its lead product candidate brelovitug—also known as BJT-778—has received US Food and Drug Administration Breakthrough Therapy designation for the treatment of chronic hepatitis D.
Brelovitug, a fully human immunoglobulin G1 monoclonal antibody that targets the surface antigen of the hepatitis B virus, has previously received Orphan and PRIME designation from the European Medicines Agency.
Keting Chu, founder and chief executive of Bluejay, said: “Chronic hepatitis delta is the most aggressive form of viral hepatitis and the lack of approved treatments in the USA creates a major unmet need for patients.
“Breakthrough Therapy designation recognizes the potential of brelovitug to transform the lives of people living with chronic hepatitis D We look forward to initiating a global pivotal trial as soon as possible to meet our goal of improving patients’ lives."
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