Healthcare companies Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) and Johnson & Johnson (J&J) (NYSE:JNJ) revealed on Thursday that they have discontinued the phase 3 E.mbrace clinical trial for their extraintestinal pathogenic E. coli vaccine candidate after an independent review found it did not demonstrate sufficient efficacy in preventing invasive E. coli disease.
The study's independent data monitoring committee identified no safety concerns related to the vaccine candidate.
Sanofi's global head of Research and Development Vaccines, Jean-François Toussaint, acknowledged the challenges of developing a preventative solution for E. coli sepsis and stressed the company's commitment to further analysis of the findings.
Sanofi and Janssen Pharmaceuticals, a Johnson & Johnson company, entered a co-development and commercialisation agreement in 2023, with Sanofi investing USD250m in upfront and development milestones. The trial, which began in June 2021, enrolled adults aged 60 and older across more than 250 sites worldwide.
Janssen Research & Development, the study sponsor, will continue safety follow-ups for enrolled participants.
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