Recce Pharmaceuticals Ltd. announced positive data from a Phase I/II trial for urinary tract infections and urosepsis, demonstrating that its lead candidate, RECCE® 327 (R327), administered intravenously is safe and efficacious against Escherichia coli. The Phase I/II study included 25 healthy participants who received R327 at doses up to 4,000mg as intravenous infusions over various infusion times (15, 20, 30, and 45 minutes). The highest dose cohort included six participants, all receiving 4,000mg of R327 over a 20-minute infusion period.

Key findings from the trial at the highest dose, 4,000mg, of R327: Consistent efficacy across participants: Most participants demonstrated significant R327 activity in their urine samples, particularly in the first hour post-dose. The concentrations achieved were sufficient to impact bacterial growth, indicating that R327 accumulates effectively in the urinary tract. Clear impact on bacterial growth build-up over time in urine: In the most recent 4,000mg cohort, the study evaluated urine samples from six participants, with 10 urine samples per participant taken over a 6-hour period.

Each urine sample was then tested ex vivo for its ability to impact the growth of E. coli, measured by an increase or decrease in luminescence. All six participants demonstrated a reduction in the rate of bacterial growth over time, with peak efficacy most often achieved 2 to 4 hours post-infusion. Sustained effectiveness: The trial data revealed that R327's effect on bacterial growth was sustained over time, with significant activity noted not only within the initial 0 to 45-minute window but also extending up 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. Rapid reduction in bacteria: In a previous study assessing the time it takes R327 to kill E. coli bacteria, R327 was shown to work faster than any other antibiotic to date, measured in minutes ? not hours.

This is an important feature of R327 and suggests the compound may be able to provide rapid relief to patients. The Phase I/II trial met all its primary endpoints, demonstrating the compound's tolerability and significant antibacterial efficacy. Building on these promising results, the Company plans to commence a Phase II trial in patients with UTIs to further validate these findings and explore additional therapeutic indications for R327.

The Phase II study is expected to be across 30 patients with the aim to confirm the efficacious potential of R327 among more diverse populations, ensuring robust and comprehensive data to support its clinical development. Additionally, Recce is 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, with the goal of addressing the urgent global health threat posed by antibiotic-resistant pathogens.