Synthetic anti-infectives developer Recce Pharmaceuticals (ASX: RCE) has obtained positive data from a Phase I/II clinical trial for urinary tract infections (UTIs) and urosepsis.
The trials demonstrated that the company's RECCE 327 (R327) administered intravenously is safe and efficacious against Escherichia coli.
The Phase I/II study included 25 participants who received R327 at doses up to 4,000mg as intravenous infusions over various infusion times (15-mins, 20-mins, 30-mins and 45-mins). The highest dose cohort included six participants, all receiving 4,000mg of R327 over a 20- minute infusion period.
The Clinical Trial at the Highest Dose of 4,000 mg of R327 produced 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.
There was also a 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.
The trial data also 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.
Chief Medical Advisor at Recce Pharmaceuticals, Dr. Alan Dunton, said the Phase I/II trial successfully 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 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.
"The positive outcomes from this clinical trial provide more evidence of R327 as rapid acting for the treatment of serious and life-threatening bacterial infections,” Dr Dunton said.
“The ability of R327 to disrupt bacterial energy production so effectively and sustain its activity over several hours highlights its potential as a transformative treatment for serious and/or resistant bacterial infections including complicated UTIs/Urosepsis.
“The mechanism is novel as an antibacterial, which has been proven safe in humans. We are excited to further explore these findings and advance R327 through subsequent trial phases."
