Sequoia Sciences announced that the Food and Drug Administration (FDA) has granted Fast Track Designation to its investigational vaccine for recurrent urinary tract infections (UTI) caused by multi-drug resistant bacteria.

The vaccine consists of the FimH bacterial adhesion protein as well as a new adjuvant designed to induce an immune response to prevent bacterial colonization of the urinary tract. Based on extensive laboratory evidence, it has been shown that FimH is essential for E. coli colonization and enables the formation of intracellular biofilms in bladders.

The vaccine was recently evaluated in an uncontrolled Phase 1 clinical trial (n=67) in women aged 21–64 years. Within the study population, 30 patients had a two-year documented history of recurrent UTI. Results showed that the vaccine was well-tolerated and induced a strong immune response. Additional studies have been initiated to evaluate the vaccine in other populations, including patients requiring last-resort antibiotics.

Gary Eldridge, president and CEO, Sequoia Sciences, stated,  “Since UTI is a primary source of sepsis, decreasing recurrent UTI may ultimately drive down rates of hospitalization, sepsis and associated in-hospital mortality.”

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