Bluejay Therapeutics Gets EMA Orphan Status Opinion for BJT-778 in Chronic Hepatitis D

SAN MATEO, Calif., May 29, 2024-- Bluejay Therapeutics, a clinical-stage pharmaceutical company specializing in viral and liver diseases with unmet medical needs, announced that the European Medicines Agency (EMA) has provided a positive opinion on their request for orphan designation for BJT-778 to treat chronic hepatitis D (CHD). 

Keting Chu, the Founder and CEO of Bluejay Therapeutics, expressed excitement about the EMA's positive opinion, emphasizing the critical need for new therapeutic options for those suffering from this severe chronic infection. Chu emphasized the company's commitment to expediting the development of BJT-778 to make it available to patients as soon as possible. He also mentioned their eagerness to continue collaborating with the EMA and other regulatory bodies to hasten the availability of this promising treatment for CHD patients.

In addition to the orphan designation, BJT-778 has also received Priority Medicines (PRIME) designation from the EMA for treating chronic HDV, highlighting the therapy's potential in addressing the significant unmet needs of patients with serious conditions.

BJT-778 is a high-potency, fully human immunoglobulin G1 (IgG1) monoclonal antibody (mAb) targeting the hepatitis B surface antigen (anti-HBsAg mAb). It works by neutralizing and clearing hepatitis B and D virions and depleting subviral particles containing HBsAg. This mechanism may help to restore antiviral immunity and contribute to a functional cure for chronic hepatitis B (CHB). The preclinical safety and efficacy profiles of BJT-778 make it a promising candidate for combination therapies with existing and emerging treatments for both CHB and CHD. Currently, BJT-778 is under evaluation for treating CHD and as a functional cure for chronic HBV.

Bluejay Therapeutics is a private biopharmaceutical company dedicated to developing treatments for viral and liver diseases. The company's lead program, BJT-778, is considered potentially best-in-class as a fully human IgG1 anti-HBsAg mAb, developed for chronic HBV and HDV. Alongside BJT-778, Bluejay is also advancing other innovative programs for chronic HBV, including a proprietary TLR9 agonist (Cavrotolimod) and a liver-targeted transcript inhibitor (BJT-628), aiming to achieve higher rates of functional cure.

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