Bluejay Reports Positive Outcomes for Hepatitis D Treatment

Bluejay Therapeutics has recently shared promising interim results from a Phase II clinical trial evaluating their innovative human IgG1 monoclonal antibody, BJT-778, which targets chronic hepatitis D (CHD). This announcement was made during the European Association for the Study of the Liver (EASL) Congress 2024. BJT-778 specifically targets the hepatitis B surface antigen (anti-HBsAg mAb), aiming to eliminate hepatitis B and D virions and restore antiviral immunity.

The Phase II study involves 31 patients, segregated into three groups receiving varying doses of BJT-778 over 48 weeks. In Arm 1, ten patients were administered 300 mg of subcutaneous BJT-778. By Week 28, all these patients demonstrated a virologic response, characterized by a reduction of at least 2 logs in hepatitis D virus (HDV) RNA levels or by becoming HDV RNA undetectable. Additionally, these patients showed a decrease in alanine aminotransferase (ALT) from baseline levels, indicating a positive impact on liver inflammation. Notably, 67% of the Arm 1 patients achieved ALT normalization, though one patient's ALT levels, which were normal at the start, declined during the treatment. Overall, 67% of the patients in Arm 1 met the composite response endpoint.

Arm 2 of the study included 11 patients who received 600 mg of BJT-778 subcutaneously each week for 12 weeks, followed by biweekly treatments for the remaining 36 weeks. By Week 12, 80% of these patients exhibited a virologic response, and most participants demonstrated reduced ALT levels. In Arm 3, patients were given 900 mg of BJT-778 biweekly for 4 weeks and then transitioned to once-daily treatment every four weeks for 44 weeks.

Throughout the trial, BJT-778 was well tolerated across all dosage levels, with no patients experiencing severe adverse effects or treatment-related discontinuations.

Bluejay Therapeutics’ goal with BJT-778 is to eliminate hepatitis B and D virions, thereby reestablishing antiviral immunity in patients. The monoclonal antibody works by targeting the hepatitis B surface antigen, acting as a significant step forward in the treatment of CHD.

Back in June 2023, the company had successfully concluded the Phase Ia study of BJT-778 and announced its receipt of orphan and PRIME designations from the European Medicines Agency (EMA). These designations were awarded based on early promising results from the Phase I/II CHD study, further emphasizing the potential of BJT-778 as an effective treatment for chronic hepatitis D.

Bluejay Therapeutics’ progress with BJT-778 signifies a potential breakthrough in treating chronic hepatitis D, offering hope to patients who suffer from this challenging condition. The ongoing research and development, backed by positive clinical trial outcomes, position BJT-778 as a promising candidate in the biopharmaceutical landscape. The company continues to monitor and evaluate the efficacy and safety of this monoclonal antibody, aiming to bring a novel therapeutic option to the market for patients with chronic hepatitis D.