Anti-infective biotech Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has fielded positive data from its Phase 1/2 clinical trial for urinary tract infections (UTIs) and urosepsis.
The trial demonstrated that RECCE® 327 (R327), when administered intravenously, is both safe and effective against Escherichia coli (E. coli).
The study involved 25 participants who received varying doses of R327 – up to 4,000 milligrams – as intravenous infusions over different durations.
The highest dose cohort included six participants, all of whom received 4,000 milligrams of R327 over a 20-minute infusion period.
Key findings at highest dose
Consistent efficacy: Most participants showed significant R327 activity in their urine samples, particularly within the first hour post-dose, indicating effective accumulation in the urinary tract.
Impact on bacterial growth: Urine samples from the 4,000-milligram cohort were tested ex vivo for their ability to impact the growth of E. coli. All six participants demonstrated a reduction in bacterial growth rate over time, with peak efficacy often achieved 2 to 4 hours post-infusion.
Sustained effectiveness: R327's impact on bacterial growth was sustained over time, with significant activity noted from 0 to 45 minutes and extending up to 2 to 4 hours post-dosing.
Rapid reduction in bacteria: Previous studies indicated that R327 works faster than any other antibiotic to date, measured in minutes, suggesting rapid relief for patients.
Rapid-acting treatment
Recce chief medical advisor Dr. Alan Dunton said: "The positive outcomes from this clinical trial provide more evidence of R327 as a rapid-acting treatment for serious bacterial infections.
“The ability of R327 to disrupt bacterial energy production effectively and sustain its activity over several hours highlights its potential as a transformative treatment for serious and resistant bacterial infections, including complicated UTIs and urosepsis."
Linnaeus Bioscience chief scientific officer Dr Marc Sharp added: "The ability of R327 to achieve biologically relevant concentrations and exhibit antibacterial activity in urine samples is highly encouraging."
The Phase 1/2 trial met all primary endpoints, demonstrating the compound's tolerability and strong antibacterial efficacy.
Building on these promising results, Recce Pharmaceuticals plans to commence a Phase 2 trial in the second half of 2024, involving 30 patients, to further validate these findings and explore additional therapeutic indications for R327.
The company is also investigating the potential of R327 in treating a broader range of bacterial infections beyond UTIs and urosepsis, such as acute bacterial skin and skin structure infections.