ASX: RCE

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ASX: RCE

$0.0

ASX: RCE

$0.0

UTI

RECCE® 327 I.V.

RECCE® 327 (R327) was developed beginning with the end in mind, being entirely synthesised to capture and enhance unique mechanisms of action, able to overcome deadly bacterial infections, including the full suite of ESKAPE pathogens, even in their multi-drug resistant forms.

Overview

Urinary tract infections (UTIs) are a common type of infection, accounting for 10-20% of infections treated in a primary care or hospital setting and roughly 30-40% of anti-infective use in hospitals. UTIs occur when bacteria enter the urethra and infect the urinary tract. Patients typically report initial symptoms such as a feeling of full bladder after urinating and pain during urination and visit their primary care doctor for treatment. Although UTIs are most often effectively treated with antibiotics, a 2019 study revealed that nearly 90% of the most common bacteria causing UTIs are resistant to one drug, and up to 80% are resistant to two.

A urine culture can confirm the presence of bacteria in the urine and the infection, sometimes indicating the best antibiotic to start treatment. Most patients, roughly 60%, will begin to feel better within a week with the first course of antibiotics. However, several rounds of treatment may be needed for those with recurrent or complicated UTIs, or the infection can spread into the bloodstream, leading to sepsis. Sepsis that results from UTIs is referred to as urosepsis. In general, 30% of sepsis cases originate from the urogenital tract.

UTI Cases and Fatalities by Geographical Area

Worldwide

Cases

400 million

200,000

deaths in 2019

USA

50-60%

of the women in the USA will develop a UTI at some point in their lifetime

Europe

Over

4.3 million

patients acquired healthcare-associated UTIs annually

Australia

Cases

250,000

annually

UTI Patient Journey

  • Urinary Tract Infection (UTI) is one of the most common infectious diseases
  • The most common pathogen causing UTIs is Escherichia coli (E. coli) with 62%
  • One in three uncomplicated UTIs in young healthy women are Bactrim-resistant
  • One in five are resistant to five other common antibiotics.
  • Antibiotic effectiveness against common UTI pathogens has declined significantly in recent years.

Clinical Trial Complete

Following the successful completion of its Phase I and Phase I/II clinical trials, Recce Pharmaceuticals continues to advance the development of RECCE® 327 (R327) in intravenous (I.V.) formulation for the treatment of urinary tract infections (UTIs) and urosepsis, a serious and often life-threatening complication.

The Phase I trial in more than 60 healthy participants demonstrated demonstrated that R327 was safe and well tolerated at escalating doses up to 6,000 mg delivered via 1-hour infusion, with no serious adverse events reported. Pharmacokinetic analyses confirmed that R327 concentrates in the urinary tract, with urine levels up to 20 times higher than plasma, supporting its application as a targeted therapy for urinary pathogens.

The subsequent Phase I/II trial assessed faster administration, achieving infusion times as short as 15 minutes, supporting R327’s potential as a first-line ‘fast-infusion’ treatment. In laboratory testing, R327 in human urine achieved a 6-log reduction in E. coli within minutes, and bacteria could not be revived after treatment.

alt="Phase I/II UTI Recce Pharmaceuticals"
alt="rapid infusion Recce R327"

About RECCE® 327

RECCE® 327 (R327) is a synthetic anti-infective developed for the treatment of serious and potentially life-threatening infections due to Gram-positive and Gram-negative bacteria, including the full suite of ESKAPE pathogens, even in their superbug forms. R327’s novel mechanism of action (MOA) is designed to safely enter the body, identify and treat an infection, and exit – with the potential to overcome antimicrobial resistance.

In laboratory testing, R327 retained its activity through more than 25 repeat exposures with no sign of resistance, whereas amoxicillin lost activity within eight.

As an IV therapy, R327 is being developed for a broad range of bacterial infections, including UTI/urosepsis and sepsis. It holds QIDP designation from the U.S. FDA.