Bluejay Therapeutics Received Regulatory Clearance to Initiate Clinical Studies of BJT-778 for Treatment of Chronic Hepatitis B & Chronic Hepatitis D
Bluejay Therapeutics recently announced it received approval from the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) and from the local Ethics Committee to proceed with a first-in-human study of BJT-778, a best-in-class monoclonal antibody against hepatitis B surface antigen (anti-HBsAg mAb). BJT-778 neutralizes and clears hepatitis B and hepatitis D virions and depletes HBsAg-containing subviral particles, which may help to reconstitute a subject’s antiviral immunity and contribute to functional cure for chronic hepatitis B (CHB). BJT-778’s remarkable preclinical safety and efficacy profiles make it an ideal candidate for combination therapies with existing and emerging therapies for CHB and chronic hepatitis D (CHD). With the commencement of this trial, Bluejay has successfully transitioned into a clinical stage company.
Dr. Nancy Shulman, Chief Medical Officer, said “We’re excited that BJT-778 will be evaluated in healthy volunteers and in subjects with CHB and CHD. BJT-778 will be tested for safety and clinical efficacy in single ascending dose cohorts, followed by repeated doses in CHB and CHD subjects that will pave the way to evaluate BJT-778 as a part of combination therapies.”
“This is a significant milestone for Bluejay to reach in less than one and a half years since beginning of operations, a true reflection of the capability and expertise of Bluejay team. We look forward to achieving more milestones like this, such as growing the Bluejay product development pipeline for innovative cures and treatments of viral and liver diseases,” added Dr. Keting Chu, Founder and CEO of Bluejay Therapeutics.
Bluejay Therapeutics is a private biopharmaceutical company focused on the development of treatment and cures for viral and liver diseases. The company’s first target indications are CHB and CHD. CHB remains a worldwide prevalent disease with urgent unmet medical need. CHD is a disease with high rate of morbidity and mortality like cancer, and no FDA approved therapy in the US. Bluejay is advancing two approaches with the potential for high rates of functional cure: best-in-class fully human IgG1 anti-HBs monoclonal antibodies and orally bioavailable liver-targeted HBV transcript inhibitors. Most recently, Bluejay has developed a platform for liver-directed drug targeting that will be applicable to multiple therapeutic agents. For more information, visit www.bluejaytx.com.
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