Recurrent UTI

Our lead FimH vaccine

Relief for patients with recurrent urinary tract infections

Sequoia Vaccines' lead program, SEQ-400, is a FimH vaccine that is being developed for the prevention of recurrent urinary tract infections (UTIs) including those caused by multidrug-resistant bacteria, a serious condition for which there is substantial unmet medical need. SEQ-400 received FDA fast-track designation in 2017, and if approved, the vaccine has potential to change the standard of care for recurrent UTIs.

Key features

  • Large, Well-defined Market
  • Favorable Safety Profile
  • FDA-supported Expedited Development
  • Exclusive Patent Position + Market Exclusivity Periods
Indication or Program Preclinical Phase 1 Phase 2 Phase 2/3 Market


Recurrent Urinary Tract Infections

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase in progress
Phase 2/3 Phase not started
Market Phase not started

Market overview

Over $29B in U.S. healthcare costs attributed to UTIs


Sepsis deaths with UTI listed as a cause occur each year

2.837 M

Hospital discharges coded for UTI (2014); >$3 billion

3,224 M

Visits to emergency departments for UTI (2014); >$3 billion


Physician visits for UTI (2014); >$3 billion


Source(s): 2,218,800 sepsis hospitalizations in 2018 in HCUP. Statistical Brief #277, July 2021; sepsis hospitalizations are at a cost of >$62 billion in 2019 as projected by the U.S. Department of Health and Human Services (HHS), Buchman et al. Crit Car Med, 2020, 48(3), 276-288; HCUP. Statistical Brief #261, July 2020; Rhee et al. JAMA. 2017,318(13):1241-1249; Hatfield et al. Crit Care Med. 6(11),1753-1760; Seymour, et al. N Engl J Med. 2017, 376(23), 2235–44; hospital discharges for UTI exclude sepsis hospitalizations with UTI; Zilberberg MD. Open Forum Infect Dis. 2022 Jan; 9(1), 1-7; HCUP Statistical Brief #286, December 2021; HCUP Statistical Brief #268, December 2020; Agency for Healthcare Research and Quality. Statistical Brief #517, October 2018; IMS Health, NDTI, 2014, ISC#599.0, ISC#595.0, ISC#595.9, ISC#597.8.

How it works

The cause of UTIs

Extensive market research demonstrates that the majority of patients have UTIs caused by Escherichia coli (E. coli) bacteria. Data collected from more than a dozen studies indicate that FimH, a bacterial adhesin protein that is present in E. coli strains, plays an essential role in allowing E. coli to attach, invade, and colonize mammalian bladders, which lead to UTIs.

Our vaccine, SEQ-400

  • Consists of the FimH bacterial adhesin protein and adjuvant.
  • Creates an immune response against FimH to prevent bacteria from colonizing the urinary tract.
  • Under investigation for reduction of of recurrent UTIs.

Clinical studies

First Phase 1A/1B study successfully completed

Our first clinical study in women with and without a history of recurrent UTI is complete. The study enrolled 37 healthy women (Phase 1A), followed by 30 women with documented histories of recurrent UTI (Phase 1B; commercial target population).

Trial results

The investigational vaccine, SEQ-400, was highly immunogenic and well-tolerated. The data suggests that that immunization against FimH may reduce the frequency of UTIs and further investigation is warranted.

  • >150-fold increase in antibody titers
  • Well-tolerated with no severe systemic reactions
  • Recurrent UTI women (Phase 1B)
    • ~70% reduction in total recurrent UTI and UTI caused by E. coli
      • The efficacy target of the vaccine is to reduce UTI by ≥50%, which is equivalent to approved vaccines for other bacterial infections
    • Elicited functional antibody responses

FDA granted compassionate use of FimH vaccine for life-threatening UTIs

  • Qualifications for approval of compassionate use
    • No satisfactory therapy
    • Evidence that the investigational drug is safe and may be effective
  • Three women ages 68 to 73 years old and one man 76 years old have received 4 vaccinations as part of the 18-month compassionate use studies
    • Reduction in UTI caused by E. coli or Klebsiella spp. consistent with phase 1 study results

Development & milestones

Our UTI vaccine commercialization plan

Based on the promising Phase 1 results, our vaccine is proceeding to a double-blind, randomized, placebo-controlled Phase 2/3 study in 2023.

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Research & publications

Sequoia’s research and development studies and programs have been published in more than 50 peer-reviewed scientific publications. We invite you to learn more about our science.

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