A major setback in the fight against invasive E. coli disease emerged today as Sanofi and Johnson & Johnson announced the discontinuation of their phase 3 E.mbrace vaccine trial following disappointing efficacy results.
The decision came after a scheduled review by an independent data monitoring committee (IDMC) determined that the vaccine candidate failed to demonstrate sufficient efficacy in preventing invasive E. coli disease (IED) compared to placebo. The trial, identified as NCT04899336, was evaluating a novel vaccine approach to prevent serious E. coli infections, including sepsis and bacteremia.
Trial Design and Patient Population
The E.mbrace study was designed as a randomized, double-blind, placebo-controlled trial conducted across more than 250 sites spanning five continents. The study focused on adults aged 60 years or older in stable health who had experienced urinary tract infections within the previous two years. Participants received either a single dose of the vaccine candidate or placebo.
Partnership and Financial Impact
The trial discontinuation marks a significant setback for both companies, particularly following their October 2023 collaboration agreement. Under this partnership, Sanofi had committed $250 million in upfront and development milestones to Johnson & Johnson's Janssen Pharmaceuticals division, with both companies agreeing to co-fund ongoing and future research and development costs.
As a direct result of the trial's termination, Sanofi will record an impairment charge of $250 million before tax in their Q4 2024 IFRS results. This adjustment will reduce their full-year IFRS EPS from €4.59 to €4.44, though their business net income and 2025 financial guidance remain unaffected.
Scientific Impact and Future Directions
"E. coli sepsis is a devastating disease and there are no preventative measures available to date," stated Jean-François Toussaint, Global Head of Research and Development Vaccines at Sanofi. "We are disappointed to see that the vaccine was not associated with sufficient efficacy to support the trial continuation."
While no safety signals were identified during the trial, the development represents a significant setback in addressing the unmet medical need for preventing invasive E. coli infections. Janssen Research & Development, LLC, as the trial sponsor, will continue appropriate safety follow-up for currently enrolled participants.
Market and Healthcare Implications
The discontinuation of this trial highlights the ongoing challenges in developing effective vaccines against bacterial infections. For healthcare providers and patients, particularly elderly individuals prone to urinary tract infections and subsequent complications, the news means the continued absence of preventative options against invasive E. coli disease.
Despite this setback, Sanofi has reaffirmed its commitment to innovation in vaccine development, with Toussaint emphasizing their dedication to understanding the factors behind the trial's outcome and sharing further analysis when available.
