FDA Grants Breakthrough Therapy Status to Brelovitug for Hepatitis Delta

Bluejay Therapeutics, a clinical-stage biopharmaceutical company dedicated to developing potentially life-changing therapeutics for serious viral and liver diseases, announced that its lead product candidate brelovitug (also known as BJT-778) has received US Food and Drug Administration (FDA) Breakthrough Therapy designation for the treatment of chronic hepatitis delta (CHD). There are currently no approved treatments for chronic hepatitis D in the United States and most countries around the world.

“Chronic hepatitis delta is the most aggressive form of viral hepatitis and the lack of approved treatments in the United States creates a major unmet need for patients,” said Keting Chu, M.D., Ph.D., founder and chief executive officer of Bluejay Therapeutics. “Breakthrough Therapy designation recognizes 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.”

FDA Breakthrough Therapy designation is intended to expedite the development and regulatory reviews of investigational therapies for serious conditions that demonstrate promising preliminary clinical evidence and potential improvement over existing therapies.

Brelovitug has previously received Orphan and PRIME designation from the European Medicines Agency.

Brelovitug is a high potency, fully human immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets the surface antigen (anti-HBsAg) of the hepatitis B virus. Brelovitug is designed to neutralize and remove hepatitis B and hepatitis D virions and deplete HBsAg-containing subviral particles, which makes brelovitug a potentially safe and highly efficacious treatment for CHD, a condition with urgent unmet medical need. In addition, brelovitug has also shown immunomodulatory functions in CHB patients, which may help to reconstitute antiviral immunity and contribute to functional cure for CHB when combined with other agents.

Bluejay Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing potentially life-changing therapeutics for serious viral and liver diseases.

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