Urinary Track Infection (UTI)

UTIs Return Following Antimicrobial Resistance

Karen McClorey Hackett — Mon, 28 Apr 2025 09:18:54 +0000

Reviewer:

The global resistance to antibiotics is complicating the treatment of approximately 150 million urinary tract infections (UTIs) that occur annually.

According to new research, nearly half of the women presenting with symptoms at a major referral hospital have infections resistant to multiple drugs.

The study, conducted by researchers at Mzuzu University and published in the National Library of Medicine, found that the prevalence of UTIs among women assessed at Zomba Central Hospital in Malawi is 48.5%.

The most frequently isolated bacteria were Escherichia coli (27.2%), Staphylococcus species (26.5%), Enterobacter species (19.2%), Citrobacter freundii (11.9%), Proteus species (6%), Enterococcus species, and Serratia marcescens (4.6%).

Compared to other antibiotics, meropenem and amikacin were effective against most pathogens, with average sensitivity rates of 51% and 56%, respectively.

Nevertheless, high levels of resistance to ampicillin (87%), ceftriaxone (77%), ciprofloxacin (70%), gentamicin (77%), and cefoxitin (64%) were observed in this study.

"The data indicates a public health concern that extends beyond the expected physiological susceptibility during pregnancy," said Pizga Kumwenda, the study's lead investigator and a senior lecturer in microbiology and immunology at Mzuzu University.

From a UTI prevention perspective, several studies have evaluated the beneficial role of the Immunotek S.L. oral spray Uromune™ (MV140) vaccine in preventing recurrent urinary tract infections (rUTIs) caused by various pathogens.

For example, results from a long-term follow-up study on the safety and effectiveness of the MV140 vaccine for rUTIs were announced at the European Association of Urology Congress on April 6, 2024. The results show that 54% of study participants, both men and women, remained UTI-free for nine years following vaccination.

As of April 28, 2025, Uromune is unavailable in the U.S., Canada, and Spain.

However, this rUTI vaccine is commercially available and through Expanded Access Programs in approximately 20 countries, including England, Mexico, and Australia.

Information regarding Uromune vaccination services in these countries is available at this Vax-Before-Travel link.

Sub Title:

Uromune MV140 is an inactivated, oral spray, mucosal-based bacterial vaccine that reduces recurrent Urinary Tract Infections

Reference:

Characterization of urinary tract infections among females at a tertiary hospital in Malawi: a retrospective study

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Novel Urinary Tract Infection Diagnosis Coming Soon

Karen McClorey Hackett — Mon, 03 Mar 2025 20:36:56 +0000

Reviewer:

Robert Carlson, MD

With millions of women and men impacted by Urinary tract infections (UTIs) yearly, healthcare providers are embracing innovations to avoid misdiagnosis and overtreatment for this common bacterial disease.

Most UTIs are caused by uropathogenic E. coli (E. coli), but less common pathogens also cause infections.

About 400 million UTI cases and 236,000 related fatalities were estimated globally in 2019.

UTIs are characterized according to several schema and terminologies. The traditional UTI diagnosis endorsed by the U.S. CDC relies on symptoms, urinalysis, and culture, which are interpreted according to historical guidelines.

While foundational, this approach presents limitations, particularly in complex cases.

Furthermore, low-level bacteriuria and the presence of fastidious organisms are often overlooked in standard urine culture.

According to a mini-review published in January 2025, new technologies, including rapid molecular-based pathogen identification, next-generation sequencing, and advanced antimicrobial susceptibility testing, are advanced diagnostic methods representing unique challenges and advantages.

These researchers wrote, 'Given the challenges associated with traditional methods, it is unsurprising that the diagnostic field is pursuing solutions through novel technology. Market analysis demonstrates that over 30 direct-from-specimen products are developing for rapid detection, ID, phenotypic AST, and/or resistance gene detection for urinary microbes.'

'The methods can be categorized into methods that screen for bacteriuria, multiplex nucleic acid amplification tests, next-generation sequencing tests, and novel phenotypic AST approaches. Selected tests in development are described herein.'

These researchers added, 'In general, there is a tremendous need for outcomes research that defines the proper utilization of new assays amid the increasing complexity of clinical urology. Ideally, to leverage advanced diagnostics in real-world practice, the field must define the indication for such methods in the context of existing framework and definitions.'

'Only in this way can powerful analytic technologies be utilized for maximum diagnostic value.'

As of March 2025, the U.S. Centers for Disease Control and Prevention says most UTIs can be treated with antibiotics prescribed by a healthcare professional.

Uncomplicated and Recurring UTI patients require prophylactic antibiotic regimens, as vaccines are unavailable in the U.S.

As of 2025, international travelers seeking UTI vaccine appointments in about 20 countries can send requests at this Vax-Before-Travel link.

Researchers recently confirmed that the increasing burden of UTIs implies that proper prevention and treatment efforts should be strengthened, especially in high-income regions and aging societies.

Sub Title:

Oral UTI vaccine available in twenty countries in 2025

References:

Novel technologies for the diagnosis of urinary tract infections

US CDC - UTI

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UTI Vaccine Reported Very Effective in Portugal

Karen McClorey Hackett — Sun, 29 Dec 2024 10:49:29 +0000

Reviewer:

Robert Carlson, MD

A recent study found that 73% of adult Portuguese patients with urinary tract infections (UTIs) reported a reduction in symptom severity or duration of illness after treatment with Uromune™ (MV140). This inactivated oral spray serves as a novel sublingual mucosal-based bacterial vaccine.

This prospective observational study, which involved 125 patients with complicated and uncomplicated recurrent UTIs, was published in the journal MDPI Vaccines (12(12), 1426) on December 18, 2024. In addition to the primary outcome of symptom reduction, the study assessed overall patient satisfaction, adverse events, and the effectiveness of Uromune in subgroups with specific UTI risk factors.

During the 12 months following the start of treatment, 38% of patients were free of UTIs. Meanwhile, 34% reported experiencing one or two episodes, while the remaining 28% had three or more recurrent UTIs.

This data indicates a mean reduction of 3.20 UTI episodes per year per patient (with a confidence interval of 2.87 to 3.53; p < 0.001).

Based in Lisbon, Portugal, the researchers found that Uromune was more effective in post-menopausal women than in pre-menopausal women (74.7% vs. 59.4%, respectively; p = 0.029). Additionally, the vaccine was noted to be less effective in men.

Since 2017, various studies have evaluated the beneficial role of MV140 in preventing UTIs, which are among the most common bacterial infections, affecting millions of women and men annually. Uropathogenic E. coli causes most UTIs.

On November 4, 2024, the JAMA Network published a Consensus Statement for UTO clinical guideline development. However, most topics relating to the prevention, diagnosis, and treatment of UTIs lack high-quality prospective data. Clear recommendations cannot be made, and further research is of utmost importance to inform true evidence-based rather than eminence-based practice.

These researchers wrote, 'Sublingual vaccines, such as Uromune, may, in the future, be the cornerstone for prevention, even in patients with complicated UTIs, if future placebo-controlled research is able to reproduce the results of this study.'

While approved in various countries such as Mexico and the United Kingdom, Uromune™ (MV140) is not offered in Canada or the United States. International travelers can request a vaccine appointment abroad at Vax-Before-Travel.

Sub Title:

MV140 Is Effective in the Reduction of Urinary Tract Infections in Prospective Real-Life Study

Reference:

Immunoprophylaxis with MV140 Is Effective in the Reduction of Urinary Tract Infections—A Prospective Real-Life Study

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Second Oral UTI Treatment Approved, But Still No Vaccine

Karen McClorey Hackett — Mon, 28 Oct 2024 15:01:00 +0000

Reviewer:

Robert Carlson, MD

For decades, antibiotics have been the primary treatment for urinary tract infections (UTIs) in the United States. However, the growing challenge of antibiotic resistance has prompted the pharmaceutical industry to develop innovative solutions.

To address this need, the U.S. Food and Drug Administration (FDA) announced on October 25, 2024, that it approved Iterum Therapeutics plc's Orlynvah (sulopenem etzadroxil and probenecid) oral tablets for the treatment of uncomplicated urinary tract infection(s) (uUTI) caused by certain bacteria (Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis) in adult women who have limited or no alternative oral antibacterial treatment options.

An uUTI is a bacterial bladder infection in women with no structural abnormalities of their urinary tract. Approximately one-half of all women will experience at least one uUTI in their lifetime, says the FDA.

"The introduction of novel products, like ORLYNVAH™, is an important way to combat antimicrobial resistance to other approved oral agents and offers a potential solution to patients and physicians," said Corey Fishman, Iterum's Chief Executive Officer, in a press release.

"As the first oral penem approved in the U.S., ORLYNVAH offers an excellent alternative treatment option for appropriate patients in the underserved uUTI market."

ORLYNVAH is a combination of sulopenem etzadroxil, a penem antibacterial, and probenecid, a renal tubular transport inhibitor, is indicated for the treatment of uUTI caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options.

Orlynvah is taken as one oral tablet twice daily for 5 days but is not indicated for the primary or step-down treatment of complicated UTI (cUTI) or complicated intra-abdominal infections.

There are no available data on ORLYNVAH use in pregnant women to evaluate for a drug-associated risk of significant congenital disabilities, miscarriage, or adverse maternal or fetal outcomes.

Earlier in 2024, the FDA approved UTILITY therapeutics Ltd. Pivya™, a penicillin-class antibacterial tablet approved for treating female adults with uUTIs. Pivya is expected to be available in the U.S. in 2025. Pivya was previously approved in Canada, the United Kingdom, and other countries.

From a UTI prevention perspective, the Uromune™ (MV140) vaccine has been approved for adults in various countries, such as Mexico and the United Kingdom.

Uromune is an inactivated, oral spray, novel, sublingual mucosal-based bacterial vaccine that reduces recurrent UTIs. It is not FDA-approved and is unavailable in the U.S.

Sub Title:

Oral UTI vaccine offered in various countries

References:

FDA approves new treatment for uncomplicated urinary tract infections

UTI Vaccine and Treatments - October 2024

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UTI Treatment Options Now Include Antibiotics, Cranberries, Vaccines

Karen McClorey Hackett — Tue, 20 Aug 2024 18:55:24 +0000

Reviewer:

Robert Carlson, MD

With over 50% of women reporting at least one urinary tract infection (UTI) in their lives, it has become a challenge for many women to identify the best interventions.

Most UTIs are bacterial bladder infections in females with no structural abnormalities of their urinary tract.

Based on recent announcements in 2024, efforts are being made to review science-based evidence supporting potential UTI interventions.

For example, a meta-analysis and systematic review of six studies published on July 18, 2024, offered evidence supporting possible nondrug preventions. This study found that antibiotic use was 49% lower with the consumption of cranberry juice than with placebo liquid and 59% lower with no treatment.

This study also found cranberry compounds were associated with a decrease in the prevalence of UTI symptoms.

Regarding new, innovative antibiotics, the U.S. Food and Drug Administration approved Pivya™ (pivmecillinam) tablets on April 24, 2024, for the treatment of female adults with uncomplicated UTIs caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus.

The FDA says Pivua is a unique class of antibiotics with potent in vitro and in vivo activity against the most common bacteria in UTI, including resistant strains such as ESBL-producing E coli.

"Uncomplicated UTIs are a prevalent condition impacting women and one of the most frequent reasons for antibiotic use," said Peter Kim, M.D., M.S., director of the Division of Anti-Infectives in the FDA's Center for Drug Evaluation and Research, in a press release.

Over the past decade, limited studies in Europe and other countries have tested UTI vaccines, revealing positive results.

Uro-Vaxom® (OM-89) is an immunostimulant vaccine consisting of an oral tablet with 18 heat-killed strains of E coli bacteria. A review found that the risk ratio for developing at least one UTI in the female population was significantly lower in the OM-89 group (RR 0.61, 95% CI 0.48–0.78), and the mean number of UTIs was about half compared to placebo.

Uro-Vaxom has been used in Europe with minimal documented adverse events and is recommended by the European Association of Urology.

Separately, Uromune™ (MV140) is an inactivated, oral spray, mucosal-based bacterial vaccine that reduces recurrent UTIs. In clinical research over the past few years, Uromune induced immune responses systemically and in the genitourinary tract, especially the bladder's innate immune system.

Since 2017, about 21,000 patients, representing 1.5 million doses of Uromune, have been administered in special access programs in various countries.

When selecting the best UTI therapy in 2024, availability becomes essential.

According to recent announcements, UTI vaccines and Pivya may become available in the United States in 2025, which leaves cranberry UTI therapy available today.

As with all clinical sessions, the U.S. CDC says speaking with a healthcare provider is the best option.

Sub Title:

Pivya pivmecillinam tablets granted US FDA approval in 2024

References:

Cranberry Juice, Cranberry Tablets, or Liquid Therapies for Urinary Tract Infection

FDA Approves New Treatment for Uncomplicated Urinary Tract Infections

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Uncomplicated UTI CRISPR-Cas3 Treatment Shows Positive Results

Karen McClorey Hackett — Mon, 12 Aug 2024 13:24:35 +0000

Reviewer:

Robert Carlson, MD

As millions of women and men continue battling the impact of urinary tract infections (UTI), innovative, advanced technology therapies are progressing through clinical trials.

A recent Phase 2 trial evaluating LBP-EC01, a CRISPR-Cas3 genetically engineered bacteriophage therapy designed to treat patients with uncomplicated urinary tract infections (uUTIs) caused by antimicrobial-resistant (AMR) and multi-drug-resistant (MDR) Escherichia coli (E. coli), reported positive news.

CRISPR–Cas technologies have enabled programmable gene editing.

This study's primary and secondary objectives were met in the open-label randomized Part 1 of the clinical trial to treat uUTIs caused by antibiotic-resistant E. coli.

Locus Biosciences's CFO Joseph Nixon previously stated, 'Like all of our products, LBP-EC01 is very selective for the target pathogen, preserving the many species of beneficial bacteria in the patient's microbiome.'

On August 12, 2024, Locus Biosciences, which is developing a new class of precision-engineered bacteriophage treatments for a diverse set of bacterial diseases, announced the first public report of data from the randomized, uncontrolled, open-label Part 1 of its two-part, U.S. government-funded Phase 2 ELIMINATE trial.

Published by The Lancet Infectious Diseases, 39 UTI patients were randomly assigned between August 2022 and August 2023. After the protocol was updated, 31 participants were allocated into three groups with different dosing regimens.

"A regimen consisting of two days of intraurethral LBP-EC01 and three days of concurrent intravenous LBP-EC01 (1 × 1×1010 PFU) and oral TMP–SMX twice a day was well tolerated, with consistent pharmacokinetic profiles in urine and blood."

LBP-EC01 and TMP–SMX dosing resulted in a rapid and durable reduction of E. coli, eliminating clinical symptoms in evaluable patients.

These researchers concluded that 'LBP-EC01 holds promise in providing an alternative therapy for uUTIs, with further testing of the group A dosing regimen planned in the controlled, double-blind, second part of ELIMINATE.'

Juvenal E. Martinez, M.D., an investigator in the trial, said in a press release, "As the first Phase 2 engineered bacteriophage trial, ELIMINATE is breaking new ground in the quest to address increasingly prevalent serious MDR infections."

"This encouraging initial data supports the possible utility of bacteriophages and the potential of LBP-EC01 as a therapeutic option to address drug-resistant bacterial infections, such as UTIs, which have a high recurrence rate due to MDR pathogens."

This clinical trial is supported by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services.

In January 2024, BARDA provided the company with $23.9 million in research funding. BARDA previously committed up to $93 million to Locus for a $152 million program to support Phase 2 and Phase 3 clinical trials and other activities required to seek marketing approval from the U.S. FDA for LBP-EC01.

Additional UTI therapies and vaccine development information is posted by Precision Vaccinations.

Sub Title:

LBP-EC01 is a CRISPR-Cas3 genetically engineered bacteriophage therapy designed to treat patients with uncomplicated urinary tract infections caused by antimicrobial-resistant and multi-drug-resistant Escherichia coli

Reference:

Safety, pharmacokinetics, and pharmacodynamics of LBP-EC01, a CRISPR-Cas3-enhanced bacteriophage cocktail

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England Offers Ample Access to UTI Vaccines

Karen McClorey Hackett — Sat, 13 Jul 2024 20:23:15 +0000

Reviewer:

Robert Carlson, MD

The United Kingdom's NHS recently updated its urinary tract infection (UTI) webpage to explain that some people may experience persistent UTI symptoms, and current urine tests may not detect chronic infections caused by bacteria embedded in the bladder lining.

Chronic UTIs, also known as recurrent UTIs (rUTIs), are typically treated with antibiotics. The NHS advises patients to ask their GP to refer them to a specialist if they experience rUTIs.

A recent study in England revealed that a novel oral spray vaccine could potentially prevent rUTIs for years. Researchers at the Royal Berkshire Hospital conducted a significant clinical trial using the Uromune® (MV140) vaccine.

Nine years after treatment, 54% of participants in the study reported the vaccine's continued efficacy without significant side effects.

In previous clinical research, Uromune induced immune responses systemically and in the genitourinary tract, especially the bladder's innate immune system.

This multi-dose vaccine contains four whole-cell inactivated bacteria: Escherichia coli, Klebsiella pneumoniae, Proteus vulgaris, and Enterococcus faecalis. Uropathogenic Escherichia coli accounts for the majority of community-acquired UTIs.

Recently, access to Uromune in England has expanded to patients who have been treated in secondary care before referral and have failed standard treatment protocols for uncomplicated urinary tract infections, overactive bladder, and chronic bladder pain.

These vaccine providers include:

London Urologica operates from The London Clinic, a charitable hospital in central London. At The London Clinic, international consultants with teams of health professionals specialize in the care and treatment of complex medical conditions.

The Lower Urinary Tract Symptoms Service is a specialist for adult patients with complex chronic or rUTIs. Specialists in this tertiary clinic adhere to protocols requiring strict clinical governance.

The Urology Partnership (The Reading Urology Partnership) comprises consultants, each with a particular field of excellence. All consultants hold substantive appointments at the Royal Berkshire NHS Foundation Trust Hospital in Reading, Berkshire.

For rUTI patients willing to travel, the Uromune vaccine may be offered via Expanded Access Programs. These programs are for individuals for whom antibiotic therapy has failed, antibiotic-induced adverse reactions, and increasing antibiotic resistance.

Uromune is offered in the Dominican Republic, Singapore, and other countries. However, Uromune is commercially unavailable in the United States and is not U.S. FDA-approved, but UTI vaccine clinical trials are active in 2024.

International vaccine appointments can be requested at Vax-Before-Travel.

Updated on July 16, 2024 to clarify the UTI vaccine is not U.S. FDA-approved.

Sub Title:

Uromune MV140 availability in 2024 in over twenty countries

References:

Uromune MV140 Recurrent Urinary Tract Infection (rUTI) Vaccine Clinical Trials, Dosage, Indication, Side Effects

NHS - Urinary tract infections

Royal Berkshire Foundation Trust research

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Medical Tourism Services Include UTI Vaccines

Donald Hackett — Wed, 03 Jul 2024 09:52:23 +0000

Reviewer:

Robert Carlson, MD

An in-depth analysis of medical tourism reveals that companies are focusing on the needs of international patients, including access to advanced treatments, says the Company Filing Analytics Database of GlobalData, a leading data and analytics company.

On July 1, 2024, GlobalData reported medical tourism now provides an additional revenue stream for companies.

For instance, Max Healthcare Institute Ltd recently revealed that its international patient yearly revenue grew by 14%. And Fortis Healthcare Ltd.'s medical travel revenue grew 12%.

In a press release, Misa Singh, a Business Fundamentals Analyst at GlobalData, commented, "Vying for a piece of this big opportunity."

"....some (companies) are focused on positioning themselves as a key destination for international patients in certain areas of medical care."

"Other prominent discussion agendas include compliance with regulatory requirements, a focus on building reputation and brand in different countries, and the rollout of an international patient support program."

Regarding vaccine services, Vax-Before-Travel recently referred over 1,000 people to international destinations that offer access to urinary tract infection (UTI) vaccines and treatments, which are unavailable in the United States in 2024.

Sub Title:

GlobalData finds medical tourism gains prominence in 2024

References:

Medical tourism gains prominence in filing documents of companies, finds GlobalData

GlobalData Company Filings Database

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New UTI Treatments Confirm Positive Advances in 2024

Karen McClorey Hackett — Fri, 28 Jun 2024 19:10:20 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

For the first time in decades, novel urinary tract infection (UTI) treatments and vaccines are making significant progress worldwide.

Recce Pharmaceuticals Ltd today announced positive data from a Phase I/II clinical trial for UTIs and urosepsis, demonstrating that RECCE® 327 (R327) administered intravenously is safe and efficacious against Escherichia coli (E. coli).

The trial data revealed on June 28, 2024, that R327's effect on bacterial growth was sustained over time. Significant activity was noted within the initial 0 to 45-minute window and extending to 2 to 4 hours post-dosing.

This extended period of activity suggests that R327 maintains its efficacy for prolonged durations, potentially enhancing its therapeutic value in clinical settings.

Recce also confirmed it is on track to initiate a Phase II trial of R327 with UTI patients later in 2024.

Dr. Marc Sharp, chief scientific officer at Linnaeus Bioscience and one of the leading independent experts in bacterial Mechanism of Action analysis, commented in a press release, "The ability of R327 to achieve biologically relevant concentrations and exhibit antibacterial activity in urine samples is highly encouraging."

This good news follows RECCE® 327's recent addition to the World Health Organization’s Antibacterial Agents in Clinical and Preclinical Development list.

And in the United States, the Food and Drug Administration (FDA) approved Pivya (pivmecillinam) on April 24, 2024, for adult women with uncomplicated UTIs.

The U.S. NIH says that compared to complicated UTIs, uncomplicated ones are less severe and more prevalent, affecting more than half of women during their lifetime.

Peter Kim, M.D., M.S., director of the Division of Anti-Infectives in the FDA’s Center for Drug Evaluation and Research, commented in a press release, “The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective, and Pivya will provide an additional treatment option for uncomplicated UTIs.”

According to an NYT report, Pivya's availability in the U.S. is forecasted for 2025.

Furthermore, progress is being reported on Spain-based Immunotek S.L.'s Uromune™ (MV140) inactivated, oral spray UTI vaccine. Various clinical studies have evaluated the beneficial role of Uromen in preventing recurring UTIs.

Uromune began clinical evaluations in 2010 and is now available in Mexico, the Dominican Republic, Singapore, and England.

Off-license use is limited in about 20 countries through special access programs. The U.S. recently discontinued its Uromune vaccine access program.

Sub Title:

RECCE 327 administered intravenously found safe and efficacious against E. coli

References:

Data From Phase I/II UTI/Urosepsis Rapid Infusion Clinical Trial of RECCE® 327

FDA Approves New Treatment for Uncomplicated UTI

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Innovative UTI Medication Needed for Children

Karen McClorey Hackett — Tue, 11 Jun 2024 21:12:33 +0000

Reviewer:

Robert Carlson, MD

A new analysis of emergency department (ED) visits for pediatric urinary tract infections (UTIs sheds light on antibiotic prescribing practices, as reported today in the journal Pediatrics.

Published on June 11, 2024, the Research Brief assessed changes in antibiotic prescribing at ED visits for pediatric UTIs from 2011 to 2020 using nationally representative data from the National Hospital Ambulatory Medical Care Survey. A total of 1,083 UTI visits by non-pregnant patients ages 18 and younger were included in the analysis.

Over the study period, trimethoprim-sulfamethoxazole prescriptions declined from 20.6% to 9.9% of visits, while the use of cephalosporins increased from 15.2% to 32.6% of visits, and the use of third-generation cephalosporins (e3GC) remained unchanged.

"Although e3GC use had increased previously, their prescription rate did not significantly change, perhaps reflecting appropriate use in areas with higher resistance," the authors wrote.

"Given their association with the development of resistance, ongoing monitoring and quality improvement will be important."

According to the U.S. CDC, UTIs are common infections in children caused by bacteria, often from the skin or rectum, entering the urethra and infecting the urinary tract. In high-income countries, UTIs affect up to 2.8% of children annually, with recurrence rates ranging from 8% to 30%.

Specifically, recurrent urinary tract infections (rUTIs) pose a significant health concern, particularly among young women. It is estimated that 11.3% of females develop at least one episode of UTI within the first 16 years of life.

A separate announcement today indicates that the next-generation RECCE® 327 intravenous and topical therapy is successfully advancing in phase 2 research. RECCE 327 is being developed to treat severe and potentially life-thretions caused by Gram-positive and Gram-negative bacteria.

Australia-based Recce Pharmaceuticals Limited reports it has completed the dosing of its latest cohort in its Phase I/II UTI/Urosepsis clinical trial, evaluating RECCE® 327 at fast infusion rates.

An Independent Safety Committee will review and evaluate the data, with preliminary results expected in mid-2024.

Data from this trial is expected to pave the way for a Phase II UTI/Urosepsis efficacy trial, potentially establishing R327 as a frontline treatment.

According to the Company, administering antibiotics through rapid intravenous infusions has proven to be a safe and effective method that significantly impacts patient treatment, reduces wait times, and alleviates nursing workloads worldwide.

Recce's Chief Executive Officer James Graham commented in a press release on June 11, 2024, "We have reached a new milestone in this trial by administering a 4,000mg dose over a fast 20-minute infusion to all subjects, the highest dosage achieved so far in this clinical trial."

"This is a significant step forward in bringing us closer to establishing R327 as a leading treatment for those suffering from UTI/Urosepsis."

The U.S. FDA has awarded RECCE® 327 Qualified Infectious Disease Product designation, labeling it for Fast Track Designation.

From a prevention perspective, a restricted-access oral spray rUTI vaccine (Uromune™ MV140) is available in other countries in 2024, but not in the U.S.

Sub Title:

RECCE 327 fast dosing UTI medication advances in Phase 2 clinical research

References:

Emergency Department Antibiotic Prescribing for Pediatric Urinary Tract Infections

Cohort Dosing Complete Ph I/II UTI/Urosepsis Clinical Trial

Management of Pediatric Urinary Tract Infections

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Adolescent

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Vaccination Reduces Recurrent Urinary Tract Infections in Women

Karen McClorey Hackett — Thu, 23 May 2024 18:51:36 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

Globally, vaccine researchers are working on nonantibiotic methods to prevent recurrent urinary tract infections (rUTIs) as antibiotic resistance becomes a growing threat to this painful disease.

In the United States, about 40% of women develop a UTI at some point in their lifetime, as well as many men.

According to an article by Carissa Wong published in the journal Nature on May 2, 2024, the latest prevention approaches include an oral spray vaccine.

Immunotek S.L. Uromune™ (MV140) is a vaccine targeting recurrent UTIs that has been approved in certain countries.

After many years of effort, clinicians completed a long-term observational study at the Royal Berkshire Hospital in Reading, England, to better define MV140's clinical benefits. Presented at the European Association of Urology Congress on April 6, 2024, the non-peer-review study disclosed MV140's promising impact.

Of the 72 women and 17 men who participated in a trial of MV140, 54% remained UTI-free nine years after receiving two doses.

The study's other participants had fewer, less severe UTIs. Some people, however, did need to take a course of antibiotics due to a breakthrough infection.

According to this study, 84 participants did not report severe side effects during the nine years.

In March 2024, these scientists also found patients who received MV140 for three months were associated with a reduction in the personal burden of disease.

This secondary analysis of a phase 3 clinical trial showed a significant reduction of UTIs (from a median of six UTIs per year before vaccination) in the efficacy period in the individuals treated with three months of MV140 (median 0.0 [IQR 0.0–1.0]) compared with placebo (median 3.0 [IQR 0.5–6.0], p < 0.0001).

These scientists wrote that this nonantibiotic strategy to prevent or reduce UTIs should empower women suffering from rUTIs to live life to the fullest.

As of May 23, 2024, Uromune MV140 is unavailable in Canada or the United States, is approved in Mexico and Spain, and is available off-license in about 20 countries through special access programs.

Sub Title:

MV140 oral spray vaccine confers protection against UTIs

References:

UTIs make life miserable — scientists are finding new ways to tackle them

European Association of Urology Congress presentation 2024

Reducing Recurrent Urinary Tract Infections in Women with MV140 Impacts Personal Burden of Disease: Secondary Analyses

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Adult

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Advanced UTI Treatments Becoming Available

Karen McClorey Hackett — Wed, 15 May 2024 18:40:32 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

While antibiotics have treated most Urinary Tract Infections (UTIs) over the past, resistance to these medications has been expanding. About 20% of infected people are reportedly resistant to UTI antibiotics.

This is an unfortunate trend, as complicated UTIs may lead to hospitalized florid urosepsis, which can be fatal.

According to recent news, innovative UTI treatments are accelerating in clinical trials and gaining regulatory approvals to meet the needs of millions of women and men impacted by this common infectious disease.

For example, the U.S. Food and Drug Administration approved UTILITY therapeutics Ltd. Pivya™ (pivmecillinam) in April 2024. This medication is currently available in various countries and is expected to be available in the United States in 2025.

Immunotek S.L. Uromune™ MV140, an inactivated oral spray vaccine that reduces recurrent Urinary Tract Infections, already has limited access in over twenty countries.

Additionally, Recce Pharmaceuticals Limited is developing a new class of Synthetic Anti-Infectives designed to address antibiotic-resistant superbugs and emerging viral pathogens.

Recce reported on May 15, 2024, that it successfully dosed the first male and female participants in the next cohort in its UTI / Urosepsis phase 1/2 clinical trial with RECCE® 327, 4,000mg intravenously, at a fast infusion rate of 20 minutes.

This is the highest dose (4,000mg) tested in participants in this trial with Minimum Inhibitory Concentration activity against bacteria already identified among existing clinical samples with this increase in dose optimization, an essential exercise for regulatory purposes.

RECCE confirmed on May 15, 2024, that the full efficacious potential of R327 via intravenous administration will be made available after this clinical trial is completed.

Earlier in May, China's National Intellectual Property Administration formally Granted a new Patent Family 2 for Recce's anti-infectives "Copolymer and Method for Treatment of Bacterial Infections."

In April 2024, RECCE announced the successful batch completion under Good Manufacturing Practices for RECCE® 327, with the patented manufacturing process now producing 5,000 doses per week.

'As the Company continues to generate promising interim data from its Phase I/II UTI/Urosepsis clinical trial on both safety and efficacy, R327 is showcasing its capability to be administered over multiple fast infusion times, highlighting the potential for a groundbreaking treatment on the first patient presentation in any medical setting,' wrote the Company.

Recce Pharmaceuticals' Head of Manufacturing Arthur Kollaras said in a press release, "We are thrilled to announce the successful batch completion of human pharmaceutical grade R327, representing a crucial step forward in our mission to address the global threat of antimicrobial resistance."

UTIs are common infections caused by bacteria, often from the skin or rectum, entering the urethra and infecting the urinary tract. The infections can affect several parts of the urinary tract, but the most common type is a bladder infection, says the U.S. CDC.

Sub Title:

RECCE® 327 at 4,000 mg intravenously at a fast infusion rate of 20-minutes

References:

First Participants Dosed in Next Cohort Phase I/II UTI/Urosepsis Rapid Infusion Clinical Trial

US CDC UTI

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Age Groups:

Adult

Google News Keywords:

UTI, vaccinations

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Fact checked:

Saturday, May 25, 2024 - 18:00

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REECE Pharmaceuticals Limited May 2024

Urinary Tract Infection Vaccine Fast-Tracked

Don Hackett — Fri, 28 Jul 2017 14:17:18 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

The US Food and Drug Administration (FDA) announced that it had issued a Fast-Track designation for an investigational vaccine designed to treat recurrent urinary tract infections (UTIs) caused by multidrug-resistant (MDR) bacteria.

In granting Fast-Track status, the FDA believes that recurrent UTI caused by MDR bacteria is a serious condition for which there is an immediate medical need.

This vaccine candidate is designed to create an immune response that prevents bacteria from colonizing the urinary tract. It recently completed its first clinical trial in women.

"If approved, the vaccine could change the standard of care for recurrent UTI," said Gary Eldridge, president and CEO of Sequoia Sciences.

"Since UTI[s] are a primary source of sepsis, decreasing recurrent UTI may ultimately drive down rates of hospitalization, sepsis, and associated in-hospital mortality."

Sequoia's vaccine is designed to produce an immune response preventing bacteria from colonizing the urinary tract, and it recently completed its first clinical trial in women.

Urinary tract infections are among the most common infections in people, and antibiotic treatment is usually helpful in treating an infection. UTIs can affect several parts of the urinary tract, but the most common type of UTI is a bladder infection (also known as cystitis).

Women and girls are at a higher risk compared to men and boys because their urethra is shorter and closer to the anus, which makes it easier for bacteria to enter the urinary tract.

Each year, about 3 million patients in the United States and 10 million in North America, Europe, and Japan experience recurrent UTIs, about half of which are caused by antibiotic-resistant bacteria.

Fast-track designation expedites the development and review of the vaccine through the US regulatory process.

Sub Title:

Sequoia vaccine is designed to produce an immune response preventing bacteria from colonizing the urinary tract

References:

Sequoia Sciences Receives FDA Fast Track Designation for Vaccine for Urinary Tract Infections Caused by Multidrug-Resistant Bact

Urinary Tract Infection

Frequently Asked Questions: Urinary Tract Infection (Catheter-Associated Urinary Tract Infection [CAUTI] and NonCatheter-Associa

Drug and Vaccine Development for the Treatment and Prevention of Urinary Tract Infections

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Age Groups:

13–15 years

16–18 years