Bluejay Therapeutics received U.S. FDA Breakthrough Therapy Designation after the EMA PRIME and Orphan Designation for Brelovitug (BJT-778) for the Treatment of Chronic Hepatitis Delta
Bluejay plans to initiate pivotal HDV trials for monotherapy brelovitug (BJT-778, mAb to HBsAg) in 1H’25.
Brelovitug has received FDA Breakthrough Therapy Designation (Jan ’25), as well as PRIME Designation (Mar ‘24) and Orphan Drug Designation (May’24) designations from the EMA, designed to expedite the development and review of therapies that may show significant improvement over available treatments for serious conditions.
Ph2a data (up to 44-wk follow-up) from multiple dosing arms (300 mg QW, 900 mg Q1M) of BJT-778 were presented at AASLD’24. Longer-term 48-wk data across all dose arms is expected in 2H’25.
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.
Vir and Bluejay’s Ph2 data are perceived as efficacious and convenient; both companies are initiating registrational trials in 2025, which, if successful, could potentially launch in 2028
- Vir’s Ph 3 ECLIPSE registrational program, assessing combo mAb (tobevibart) + siRNA (elebsiran) regimen (2 injection, Q1M), is expected to start in 1H’25; If Ph 3 is successful, Vir could launch (base case) in 1H’28