Dynavax Technologies reported positive new data from Phase III studies evaluating its investigational hepatitis B (HBV) vaccine Heplisav™ in patients with diabetes. The data showed that Heplisav vaccination resulted in faster, more robust, and longer-lasting immunity in diabetes patients than the approved vaccine Engerix-B® (GlaxoSmithKline).
Announcement of the results coincided with new Centers for Disease Control (CRC) recommendations stating that hepatitis B vaccination should be given to unvaccinated adults with diabetes who are less than 60 years of age.
The latest diabetic patient subset data are from a modified intent to treat (MITT) analysis of the Heplisav Phase III study in adults aged 40 years and over, and represent an evaluation of the first prospectively defined diabetic population, Dynavax says. Data analysis showed that of the 218 diabetic subjects in the MITT population (179 Heplisav and 39 Engerix-B), the seroprotection rates (SPR) for Heplisav were higher than those of Engerix-B: at week 12 the SPR for the Heplisav patients was 79%, and for the Engerix-B group it was 11%. At week 52 the SPRs were 82% for Heplisav and 54% for Engerix-B.
Dynavax is developing Heplisav primarily for individuals in populations that are less responsive to current licensed vaccines. Phase III studies evaluating Heplisav in patients with chronic kidney disease are also ongoing. The firm estimates that the total worldwide market for adult monovalent hepatitis B vaccines exceeds $400 million annually, but that current vaccines leave unmet needs for more rapid and increased protection, particularly among less responsive, underserved populations.