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.
SIFI enters scientific collaboration with UCSF on Acanthamoeba Keratitis
Johnson & Johnson's nipocalimab granted FTD for treatment of Sjogren's disease
Vascarta launches phase I VAS101 clinical study in osteoarthritis
GRIN Therapeutics' Radiprodil receives Orphan Drug designation
BioArctic receives US FDA orphan drug designation OOPD for exidavnemab
Physiomics secures GBP102,000 contract with UK biotech for ADC therapy development
Revelation Biosciences reports Gemini's anti-inflammatory potential in PBMC study
Eneboparatide Shows Positive Results in Phase III Trial for Chronic Hypoparathyroidism
Precision BioSciences secures IND clearance for gene editing therapy targeting chronic hepatitis B
Biophytis advances sarcopenia treatment with positive Phase 2 results
AstraZeneca secures EU approval for Imfinzi in limited-stage small cell lung cancer
BioSurfaces collaborates with Morphocell Technologies
iOncologi acquires TargImmune Therapeutics
Argent BioPharma announces positive CimetrA Phase IIb clinical trial results