Results from the first North American Clinical Experience Study provides further evidence of MV140 safety and efficacy

Mississauga, Canada (February 12, 2024)Red Leaf Medical (RLM) announced that results from the first North American clinical evidence for MV 140, a sublingual vaccine for the prevention of recurrent urinary tract infections (rUTI) in women, were published in the Canadian Urological Association Journal (February 2024). The results provide real-life clinical evidence with Canadian women to further support the safety and benefits of MV140 for the prevention of recurrent UTIs.

Study Design, Results and Safety

A single-center, investigator-initiated, Health Canada approved, prospective case series study was conducted in Kingston, Ontario. The study’s primary outcome was looking at the UTI-free rate post vaccination with secondary outcomes looking at overall reduction in UTI compared to pre-vaccination, quality of life and safety.

The MV140 vaccine showed significant efficacy in reducing recurrent UTIs in Canadian women. Approximately 40% of women were UTI-free and UTI recurrences were reduced by 75% over the study period. Sixty-seven subjects (mean age 56 years, range 18–80) were enrolled; 64 completed the vaccination period and at least one post-vaccination assessment. Prior to vaccination, subjects reported a mean 6.8 UTIs/year. The UTI-free rate for the nine-month efficacy period was 40.6%. Compared to the infection rate in the year prior to vaccination, the reduction was 75.3% for the nine-month efficacy period post-vaccination. At 12-month follow up, 80.3% reported that they were moderately/markedly improved. The study offers additional evidence to confirm the positive safety profile of MV140 with no major adverse events reported. The 9 potential adverse events related to the vaccine were all mild and resolved by three months.

“The results from this real-world study of Canadian women offers hope for a breakthrough in managing and preventing recurrent UTIs,” said principal investigator Dr. J. Curtis Nickel, MD, FRCSC, Professor Emeritus Urology at Queen’s University and Associate Staff Urologist at Kingston Health Sciences Centre in Canada. “Recurrent UTI is a major health issue and women want alternatives to the existing treatment of taking antibiotics for extended periods of time resulting in unwanted side effects and increasing the risk of antimicrobial resistance.”

Commenting on the study in the CUAJ, Dr Duane Hickling, Department of Urology, The Ottawa Hospital, noted: As we await further studies in vulnerable patient populations and regulatory approvals, the MV140 sublingual vaccine presents itself as a promising therapeutic option, heralding new possibilities in combating recurrent UTIs. Its potential to alleviate the physical and economic burden associated with recurrent UTIs offers renewed hope to affected individuals, their families, and healthcare providers alike.

About UTIs

Currently, antibiotics remain the only evidence-based recommended treatment for recurrent UTIs and are given for each infection or as continuous daily-dosing prophylaxis. When the patient stops taking antibiotics, however, their UTIs come back with the same frequency they had prior to starting treatment.[i]

UTIs are one of the most common infections in Canada.[i] More than 50% of women experience a Urinary Tract Infection (UTI) in their lifetime[ii], with 20% to 40% of those suffering recurrences and requiring multiple short and long-term dosing of antibiotics.[iii]  Recurrent UTIs are defined as three or more UTIs during a 12-month period or 2 or more during a 6-month period.ii  UTIs are also the most common infection in older adults and the leading infection requiring antimicrobials in long term care.[iv]

Symptoms of UTIs include a burning feeling when urinating, frequent and intense urges to urinate, pain and pressure in the lower back or abdomen, discolored and strange-smelling urine, and fever or chills. A woman’s daily activities are severely impacted by rUTI and can result in time off employment, with one study noting a mean 1-2 sick days for each acute episode. [v] A Canadian study noted that women wait up to 5 days before seeking medical attention and had symptoms for a mean of 4.9 days after diagnosis. Sixty-three percent of women with UTIs in the study reported a significant impact on usual activities.[vi]

A woman’s mental well-being is also severely impacted by rUTI. The sudden, unforeseeable and distressing nature of painful UTI episodes often cause patients anxiety.[vii] Mental health scores are reportedly below average in up to 81% of women, regardless of whether the woman is suffering an acute infection or is between infections, and up to 71% of women suffering from rUTI exhibited some degree of depression. vii

The Cost of UTI’s and the Rise of Antimicrobial Resistance (AMR)

The Canadian Council of Academies (CCA) iii estimated that in 2018:

  • Approximately 23.9% of UTIs (1 in 4 patients) in Canada were resistant to antibiotics used to treat them
  • UTIs cost the Canadian health care system approximately 350 million dollars
  • Hospital cost per resistant UTI is approximately 20,000 dollars
  • UTIs were responsible for 6,700 deaths
  • UTIs were responsible for 3,000 years of lost employment
  • Antimicrobial resistance is likely to grow at an alarming rate – from 26% in 2018 to 40% in 2050 costing the healthcare system six to eight billion dollars a year.

Continued use of antibiotics for the treatment or prevention of UTIs not only contributes to the ill health of individual patients, but also to the alarming rise of antibiotic resistance. In Canada, this represents an exorbitant amount of antibiotics — a significant cost and burden to both society and patients. vii

About MV140

MV140 is a self-administered vaccine that works by stimulating the immune system, particularly the innate immune system of the bladder. The vaccine is a sublingual spray and the patient administers two sprays under the tongue once daily for three months. UROMUNE™ is composed of four whole cell inactivated bacteria, including equal amounts of UTI-causing pathogens: Escherichia coli; Klebsiella pneumoniae; Proteus vulgaris; and Enterococcus faecalis. UROMUNE™ was developed by Inmunotek, an innovative pharmaceutical company based in Spain. The product is exclusively licensed in Canada to Red Leaf Medical.

About Red Leaf Medical

Red Leaf Medical is a leading Canadian healthcare company specializing in urology and infectious disease. The Company provides innovative therapies and solutions in the areas of pelvic floor health, fertility and urinary tract infections. Red Leaf Medical is a trusted partner to patients and healthcare providers offering industry leading products and patient support programs. Founded in 2009, the company continues to expand its portfolio by launching important new products and services, such as CathetersPLUS™ and ConceptionPLUS™. Learn more at

[i] Council of Canadian Academies, 2019. When Antibiotics Fail. Ottawa (ON): The Expert Panel on the Potential Socio-Economic Impacts of Antimicrobial Resistance in Canada, Council of Canadian Academies.

[ii] Foxman B, Barlow R, D’Arcy H, et al. Self-reported incidence of urinary tract infection and associated costs. Ann Epidemiol 2000;10:509-15.

[iii] Epp A, Larochelle. ASOGC clinical guidelines for rUTI. J Obstet Gynaecol Can 2017;39:e422-31.

[iv] Nicolle, L. (2013). Urinary Tract Infection. In J. F. M. Nunez, J. S. Cameron & D. G. Oreopoulos (Eds.), The Aging Kidney in Health and Disease. London, United Kingdom: Spring Science+Business Media.

[v] Wagenlehner F, Wullt B, Ballarini S et al: Social and economic burden of recurrent urinary tract infections and quality of life: a patient web-based study (GESPRIT). Expert Rev Pharmacoecon Outcomes Res 2018; 18: 107-117.

[vi] Nickel JC, Lee JC, Grantmyre JE, Polygenis D.  Natural history of urinary tract infection in a primary care environment in Canada.  Can J Urol 12:2728-2737, 2005.

[vii] Renard J, Ballarini S, Mascarenhas T et al. Recurrent lower urinary tract infections have a detrimental effect on patient quality of life: a prospective, observational study. Infect Dis Ther 2015; 4: 125-135.

[i] Anger J, Lee U, Ackerman AL. Recurrent Uncomplicated Urinary Tract Infections in Women: AUA/CUA/SUFU Guideline. J Urol 2019;202:282-289.