Dynavax Reports Diabetic Subset Data from MITT Analysis of the HEPLISAV™ Phase 3 Trial
Dynavax Technologies Corporation has announced the results of a prospective analysis of the diabetic subset population from its Phase 3 trial (HBV-16), showing the superiority of HEPLISAV vs. Engerix-B®, at all measured time points.
The modified intent to treat (MITT) analysis of adults with type II diabetes showed that HEPLISAV given as 2 doses over 4 weeks protected a significantly greater proportion of subjects in a shorter time and with longer-lasting protection than Engerix-B given as 3 doses over 24 weeks.
The modified intent to treat (MITT) subpopulations included all diabetic subjects that had received at least one dose of any of the four HEPLISAV lots or Engerix-B and had at least one post vaccination immunogenicity result.
• Of the 218 diabetics in the MITT population (179 HEPLISAV; 39 Engerix-B), the SPRs for HEPLISAV were superior to Engerix-B at weeks 8 through 52.
• At the prespecified comparison time points of week 12 for HEPLISAV and week 32 for Engerix-B, the SPR was 79% in the HEPLISAV group and 61% in the Engerix-B group.
• At week 12, the SPR was 79% in the HEPLISAV group and 11% in the Engerix-B.
• At week 52, the SPR in the HEPLISAV group was 82% whereas the SPR in the Engerix-B group was 54% by week 52.
According to Tyler Martin, M.D., President and Chief Medical Officer, "The Phase 3 results we are reporting today for HEPLISAV vs. Engerix-B are the first to be obtained in a prospectively defined diabetic population. The data clearly demonstrate the superiority of HEPLISAV in diabetics and confirm our retrospective analysis reported last year. In light of the current public health discussions regarding HBV protection of this susceptible population, these results have important medical significance."