Press Release: Update on extraintestinal pathogenic E. coli vaccine phase 3 clinical study

Core Insights - The E.mbrace phase 3 clinical study for the extraintestinal pathogenic E. coli vaccine candidate by Sanofi and Johnson & Johnson has been discontinued due to insufficient efficacy in preventing invasive E. coli disease compared to placebo [1][7] - No safety concerns were identified during the study, and participants who developed invasive E. coli disease received appropriate treatment [1][7] Study Details - The E.mbrace study was a randomized, double-blind, placebo-controlled trial evaluating the efficacy, safety, and immunogenicity of a single dose of the vaccine candidate in preventing invasive E. coli disease, including sepsis and bacteremia [3] - The study began in June 2021, enrolling adults aged 60 years or older with a history of urinary tract infections in the past two years, conducted at over 250 sites across five continents [4] Financial Impact - Following the study's discontinuation, Sanofi recorded an impairment charge of $250 million before tax in Q4 2024, affecting the full-year IFRS EPS, which decreased from €4.59 to €4.44 [5] - The business net income and business EPS remain unchanged at €8,912 million and €7.12 respectively, with no change to the financial guidance for 2025 [5] Company Commitment - Sanofi expressed disappointment over the trial results but remains committed to driving innovation in research and development, particularly in areas of high unmet medical need [2]