Dynavax Phase 3 Demonstrates Superiority and Safety of HEPLISAV vs. Engerix-B

Dynavax Technologies Corporation DVAX today said that top-line data from its Phase 3 trial comparing HEPLISAV, an investigational hepatitis B virus (HBV) vaccine, to a currently marketed HBV vaccine, Engerix-B, demonstrated non-inferiority, superiority and the safety of HEPLISAV. The study evaluated a two-dose regimen of HEPLISAV administered at 0 and 1 month compared to a three-dose regimen of Engerix-B administered at 0, 1 and 6 months. The trial studied 2,449 healthy adults 40 to 70 years of age, randomized to HEPLISAV or Engerix-B in a 4:1 ratio. Data supporting the consistency of three consecutively manufactured lots of HEPLISAV have been submitted to the Food and Drug Administration (FDA), and Dynavax expects confirmation of its analysis shortly.