US biopharmaceutical company Dynavax is planning a phase III trial of its Heplisav adult hepatitis B vaccine in chronic kidney-disease patients.
The new drug is designed to provide increased and rapid protection with fewer doses than current licensed alternatives.
Dynavax has worldwide commercial rights to Heplisav, which combines hepatitis B surface antigen (HBsAg) with a proprietary Toll-like Receptor 9 (TLR9) agonist to enhance the immune response.
The company reports that 2,500 people have been vaccinated with Heplisav to date. Data from PHAST clinical trials reportedly show a seroprotection rate of 92%, compared to 75% of subjects receiving 3 doses of a licensed vaccine over six month
Says Dynavax boss Dino Dina: “The success of our scientific approach to resolving the clinical hold on Heplisav allows us to resume development of our hepatitis B vaccine.
“After achieving strong efficacy data in our prior phase 3 pivotal trial, we are fully prepared to initiate the final registration trials for Heplisav.”
Copyright Press Association 2009