Johnson and Johnson (J&J) has announced the cancellation of its Phase III E.mbrace study examining Sanofi’s investigational vaccine for extraintestinal pathogenic Escherichia coli (E. Coli) after results were found to be underwhelming.
The multinational healthcare giant put a stop to the randomised, double-blind, placebo-controlled trial (NCT04899336) after an independent interim analysis found that the vaccine, known as ExPEC, failed to demonstrate sufficient efficacy in preventing the invasive disease compared to placebo.
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In October of 2023, Sanofi and J&J entered an agreement that saw Sanofi pay out $250m upfront. Originally initiated in 2021, the trial enrolled nearly 20,000 participants at 250 sites across five continents, with J&J subsidiary Janssen Research & Development heading up the process. The trial specifically sought to recruit patients aged 60 and above with a recent history of urinary tract infection.
Jean-François Toussaint, global head of research and development in vaccines at Sanofi, said: “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.
“While disappointed by this outcome, we remain steadfast in our commitment to drive innovation in R&D by developing first and best-in-class vaccines in areas of high unmet need.”
Following the announcement, Sanofi recorded an impairment charge before tax of $250m, but stated there had been no resulting impact to its net income.
Research by GlobalData estimates that if the drug had been successful, it would have generated sales of around $464m by the end of 2030. Of that, more than half was forecast to come from the US market.
E. Coli typically manifests as food poisoning that stemmed from undercooked or poorly stored food. While some strains of E. Coli can generally be tolerated, the infection can, in severe cases, result in death.
The US Centres for Disease Control (CDC) estimates that the O157:H7 strain E. Coli causes 73,000 illnesses across the US annually.
Elsewhere in the E. Coli space, the US Army has awarded a contract to develop bacteriophages to treat uropathogenic E. Coli infections to the South Korean biotech company iNtRON Biotechnology.
