Bluejay Announces Receipt of PRIME Designation from European Medicines Agency (EMA) for BJT-778 for the Treatment of Chronic Hepatitis Delta Virus Infection
Currently Enrolling Phase 2 Study of BJT-778 in HDV; Interim Data Expected second half of 2024
SAN MATEO, Calif., March 25, 2024 (GLOBE NEWSWIRE) — Bluejay Therapeutics, Inc., a private clinical-stage biopharmaceutical company focused on viral and liver diseases, today announced the European Medicines Agency (EMA) has granted Priority Medicine (PRIME) designation to BJT-778 for the treatment of Chronic Hepatitis Delta Virus (HDV) infection. BJT-778 is a high-potency, fully human immunoglobulin G1 (IgG1) mAb that acts as an anti-viral to HDV by neutralizing and facilitating the clearance of HDV virions. The application for PRIME designation was bolstered by compelling data from non-clinical studies, along with interim results from the company’s Phase 1/2 study that included subjects with chronic HDV.
“We are grateful for EMA’s decision to grant PRIME designation to BJT-778 for treatment of chronic HDV, affirming its potential to fulfill the unmet medical need as a new therapeutic option for this severe disease. This will accelerate our development process to provide a well-tolerated and efficacious treatment for patients globally and save lives,” said Keting Chu, Chief Executive Officer at Bluejay. “We eagerly anticipate our continued collaboration with the EMA and other regulatory agencies to expedite the availability of this promising treatment for patients.”
About Bluejay Therapeutics
Bluejay Therapeutics is a private biopharmaceutical company focused on the development of treatments for viral and liver diseases. The Company’s lead program, BJT-778 is a potentially best-in-class fully human IgG1 monoclonal antibody against hepatitis B surface antigen (anti-HBsAg mAb), being developed for both chronic HBV and HDV. BJT-778 is designed to provide anti-HBV and anti-HDV benefits by neutralizing and clearing HBV and HDV virions as well as by depleting HBsAg-containing subviral particles, which may help to reconstitute a subject’s antiviral immunity and contribute to functional cure for CHB. Bluejay is also developing and advancing other innovative programs for chronic HBV, including a proprietary TLR9 agonist (Cavrotolimod) and a liver targeted transcript inhibitor (BJT-628), with the goal of achieving higher rates of functional cure. For more information on Bluejay, please visit the company’s website at www.bluejaytx.com.
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