Thursday, May 30, 2024
Bluejay Therapeutics, a clinical-stage biopharmaceutical company focused on addressing viral and liver diseases with unmet medical needs, has received positive news from the European Medicines Agency (EMA) regarding its application for orphan designation for BJT-778 in treating chronic hepatitis D (CHD).
"We are excited about the EMA's positive opinion granting orphan designation for BJT-778. This recognition emphasizes the urgent need for new treatment options for individuals affected by this debilitating chronic infection," stated Keting Chu, Founder and CEO of Bluejay Therapeutics. "Our aim is to expedite the development of BJT-778 and make it accessible to patients as soon as possible. We eagerly anticipate further collaboration with the EMA and other regulatory bodies to accelerate the availability of this promising treatment for CHD patients."
In addition to orphan designation, BJT-778 has also been granted Priority Medicines (PRIME) designation by the EMA for chronic HDV treatment, highlighting its potential to address significant unmet needs in patients facing these severe conditions.
BJT-778 is a high-potency, fully human immunoglobulin G1 (IgG1) monoclonal antibody (mAb) targeting hepatitis B surface antigen (anti-HBsAg mAb). This antibody neutralizes and eliminates both hepatitis B and hepatitis D virions while depleting HBsAg-containing subviral particles, potentially aiding in the restoration of antiviral immunity and contributing to a functional cure for chronic hepatitis B (CHB). BJT-778's robust preclinical safety and efficacy profiles position it as an ideal candidate for combination therapies with existing and emerging treatments for CHB and CHD. Currently, BJT-778 is under evaluation for CHD treatment and as a potential functional cure for chronic HBV.
Source: globenewswire.com
