Vaccine Info

RECCE 327 Urinary Tract Infection (UTI) Treatment

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Staff
Last reviewed
June 18, 2024
Fact checked by
Robert Carlson, MD
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RECCE® 327 Urinary Tract Infection (UTI) Treatment

Recce Pharmaceuticals Ltd.'s anti-infective pipeline includes patented, broad-spectrum, synthetic polymer RECCE® 327 (R327), an intravenous and topical therapy being developed for the treatment of severe and potentially life-threatening infections caused by both Gram-positive and Gram-negative bacteria,  including their superbug forms, such as Urinary Tract Infections (UTIs), which are common infectious diseases caused by pathogens, such as Escherichia coli (62%). Recce's anti-infectives are wholly synthetic, based on a patented polymeric structure, and designed to overcome resistance. Recce's anti-infectives can potentially overcome the hypercellular mutation of bacteria and viruses, which is the challenge of all existing antibiotics. R327 affects the assembly of bacterial cell division complex components that require cellular energy to remain assembled, confirming its ability to disrupt cellular bioenergetics. This decreases the formation of the bacterial cell division complex into ring-like structures (Z-rings) in a concentration-dependent manner. RECCE® 327 is not a UTI preventive vaccine.

The U.S. Food and Drug Administration (FDA) has awarded RECCE® 327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act, labeling it for Fast Track Designation, plus ten years of market exclusivity post approval. On May 7, 2024, Recce announced that the China National Intellectual Property Administration Granted a new Patent Family 2 for Recce's anti-infectives, "Copolymer and Method for Treatment of Bacterial Infections" in China, expiry 2035.

According to the World Health Organization (WHO), RECCE® 327 was added to the WHO List of Antibacterial Products in Clinical Development on June 18, 2024. R327 is the only compound classified as an adenosine triphosphate (ATP) production disruptor. Disruption of ATP production in bacterial cells, when targeted as the primary mechanism of action, not secondary to other cell perturbation mechanisms, carries the potential to confer activity against Gram-positive and Gram-negative pathogens.

On May 15, 2024, Recce reported that it had successfully dosed the first male and female participants in the nexCohortrt with RECCE® 327, 4,000mg intravenously, at a fast infusion rate of 20 minutes in its Phase I/II UTI/Urosepsis clinical trial. As of June 11, 2024, Recce had dosed six human subjects in the fast infusion intravenous study.

Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) is developing a New Class of Synthetic Anti-Infectives designed to address the urgent global health problems of antibiotic-resistant superbugs and emerging viral pathogens. On June 18, 2024, the company confirmed a further cash refund of AUD $2,624,860.47 Research and Development Tax Incentive rebate from the Australian Tax Office for the financial year ending 30 June 2023.

RECCE® 327 UTI Treatment Dosage

RECCE® 327 may be administered for intravenous, topical, nasal, oral, and inhaled use. RECCE® 327's universal mechanism of action has a patented ability to continuously kill bacteria without a tendency for the emergence of resistance, even with repeated use, indicating a unique ability to combat antibiotic-resistant superbugs. The Company has explored multiple infusion times of R327: 15 minutes, 20 minutes, 30 minutes, and 45 minutes. The highest dose tested in the phase 1 study is 4,000mg. 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® 327 UTI Treatment Indication

Data in 2024 is expected to pave the way for a Phase II UTI/Urosepsis efficacy trial, potentially establishing R327 as a frontline treatment. Urinary tract infection (UTI) is one of the most common infectious diseases in the pediatric population. In high-income countries, UTIs affect up to 2.8% of children annually, with recurrence rates ranging from 8% to 30% [2,3]. It is estimated that 11.3% of females and 3.6% of males develop at least one episode of UTI within the first 16 years of life.

RECCE® 327 UTI Treatment Side Effects

No significant side effects have been reported. In April 2024, Recce Pharmaceuticals reported that an Independent Safety Committee had approved an increase of R327 to 4,000mg (I.V.) over a fast infusion of 30 minutes. Subject recruitment is underway, and six subjects are expected to start/complete dosing shortly.

RECCE® 327 UTI Treatment Availability

RECCE® 327 is not market-approved for human use. As of April 2024, the Company was producing 5,000 GMP doses of R327 per week.

RECCE® 327 UTI Treatment News

June 18, 2024 - CEO of Recce Pharmaceuticals, James Graham, said, "We are pleased that R327 has been included in the list of antibacterial products aimed at tackling the urgent global health threat posed by antibiotic resistance. There is a demand for new antibiotic therapies, and this report further showcases R327's potential as a novel treatment for a broad range of life-threatening and resistant bacteria."

May 15, 2024 - The first participants were successfully dosed at 4,000mg IV over 20 minutes, at 4,000mg in a phase 1/2 study.

April 17, 2024 - Recce Pharmaceuticals Ltd. announced the successful batch completion under Good Manufacturing Practices for RECCE® 327 (R327), with the patented manufacturing process now producing 5,000 GMP doses of R327 per week.

September 26, 2023 - Recce Pharmaceuticals Ltd. announced it completed the cohort dosing of healthy male and female subjects in its Phase I/II clinical trial, evaluating its lead anti-infective candidate, RECCE® 327, at faster infusion rates.

RECCE® 327 UTI Treatment Clinical Trials

UTI clinical trials are active as of May 2024. A phase 1 clinical trial (ACTRN12623000448640) consists of up to 4 cohorts with 4 participants at each dose level. Each participant will begin with a single dose of RECCE®327 intravenously over Period A (longer infusion duration), followed by 48 hours of safety surveillance and PK data collection. The second dose of RECCE®327 infusion over Period B (shorter infusion duration) had the same dose level and concentration and a minimum time elapsed of 48 hours from the start of the first to the second dose. For the subsequent, a non-Data Safety Monitoring Board (DSMB) committee will review the safety and PK data (the latter, if available). It may suggest adjusting the dose level, infusion rate, and/ or concentration of the RECCE®327 before proceeding to the nexCohortrt. The non-DSMB committee may determine not to proceed with additional cohorts as well. Four non-DSMB committee meetings will be planned one week after Period B for the last participant in eacCohortrt.

Clinical Trials

No clinical trials found