Drugmakers Sanofi and Johnson & Johnson announced yesterday that they're pulling the plug on a phase 3 trial of their joint vaccine candidate for extraintestinal pathogenic Escherichia coli.
The companies said in a news release that in a scheduled review of the E.mbrace 3 trial, an independent data monitoring committee (IDMC) determined that the vaccine—ExPEC9V—was not sufficiently effective at preventing invasive E coli disease (IED) compared with placebo and recommended discontinuing the study. Initiated in 2021, the trial was testing the efficacy, safety, and immunogenicity of the vaccine in preventing IED, which includes sepsis and bloodstream infections, in adults 60 and older.
Extraintestinal pathogenic E coli causes an estimated 10 million cases of IED annually and is a leading cause of sepsis, particularly in older adults with chronic illnesses.
Disappointing findings
"E. coli sepsis is a devastating disease and there are no preventative measures available to date," said Jean-Francois Toussaint, PhD, MBA, Sanofi's global head of vaccine research and development. "We are disappointed to see that the vaccine was not associated with sufficient efficacy to support the trial continuation, and we will work tirelessly to understand the factors behind the IDMC's finding and to share further analysis once available."
Sanofi entered into agreement with Johnson & Johnson in October 2023 to co-fund future research and development costs for the vaccine, which was developed by Johnson & Johnson subsidiary Janssen Pharmaceuticals.
No safety events related to the vaccine were identified in the trial, and investigators said participants who developed IED received prompt treatment and care.