Dynavax Technologies Corporation (NASDAQ:DVAX) has announced the completion of registration of 119 patients in its clinical study evaluating its Hepatitis B vaccine HEPLISAV-B in treating end-stage renal disease patients that are commencing or continuing with hemodialysis.
HBV-24 study to evaluate different dose regimens of HEPLISAV-B
The company is expecting the final immunogenicity trial data to be released in the fourth quarter of this year. Robert Janssen, the company’s Chief Medical Officer, indicated that completing the enrolment of patients is the study is a huge milestone for Dynavax. Jannsen added that the company is evaluating a new four-dose HEPLISAV-B regimen in adult patients with ESRD that are under hemodialysis.
The study will offer a vital Hepatitis B vaccine alternative for patients with ESRD on dialysis. The chief medical officer indicated that the company was looking forward to having a scientific presentation of data from the study in the right forum soon.
Dynavax is conducting the HBV-24 study as an open-label, single-arm study in the US. They will evaluate the HEPLISAV-B 4-dose regimen in ESRD patients currently under hemodialysis and have not received any hepatitis B vaccine before. The study will evaluate the immunogenicity of HEPLISAV-b after 20 weeks and its safety throughout the study, which will be around 68 weeks. So far, safety and efficacy of the recombinant Hepatitis B vaccine are yet to be established in adult patients undergoing hemodialysis.
HEPLISAV-B indicated to prevent Hepatitis B infection
Hepatitis B is a serious viral disease that affects the liver and can be chronic, leading to liver cirrhosis and even death. There is no cure for Hepatitis B, which has been on the rise, but having an effective vaccine like HEPLISAVB can be effective in preventing the disease. The HEPLISAV-B vaccine uses the hepatitis B surface antigen and the proprietary Toll-like Receptor 9 agonist of Dynavax to boost the immune response in patients.
The company has commercial rights globally for HEPLISAV-B. The vaccine is indicated for infection prevention that results from different Hepatitis-B subtypes in adult patients.