Recce Pharmaceuticals Announces First Cohort Dosed in RECCE 327 Rapid Infusion Phase I/II Urinary Tract Infection (UTI) Clinical Trial

Highlights:

• First cohort in Phase I/II urinary tract infection (UTI) rapid infusion intravenous (IV) study successfully dosed 2,500mg of RECCE 327 (R327), resulting in high peak urine concentrations, as previously demonstrated in a completed Phase I clinical trial
• High concentrations of R327 in urine are expected to demonstrate a rapid kill rate of bacteria in line with pre-clinical UTI study results
• First female safely dosed with R327 IV 2,500mg at 30-minute infusion
• Broadened patient population by accelerating recruitment in Adelaide (CMAX) and Sydney (Scientia Clinical Research) to meet study schedule
• Results will define dose(s)/infusion rates for upcoming Phase II single-dose study in patients with UTIs
  

SYDNEY, Australia, July 11, 2023 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Limited (ASX: RCE, FSE: R9Q), the Company developing a new class of synthetic anti-infectives, is pleased to announce it dosed the first cohort of both male and female subjects with no serious adverse events in a Phase I/II urinary tract infection (UTI) clinical trial evaluating RECCE 327 (R327) at faster infusion rates.

“This current study builds off of Recce’s completed 80 subject Phase I study of R327 administered as a 1-hour infusion, demonstrating that R327 concentrated in the urine by at least 15-fold compared to plasma concentrations,” said Alan W Dunton, MD, Non-Executive Director of Recce Pharmaceuticals and Medical Monitor of the Phase I/II clinical trial. “Peak concentrations of R327 in urine noted in the study have corresponded to in vitro results in human urine to effectively kill E. coli within minutes, not hours, as is seen for currently used and approved antibiotics for UTI treatment. It is estimated that more than 70% of UTI patients have bacteria in their urine, which are now resistant to two or more antibiotics.¹ Furthermore, UTI infections are the foundational contributor to more than 30% of sepsis cases globally.²”

Participants in the cohort were all dosed at two faster infusion rates of 2,500mg compared to the Company’s completed 80 subject Phase I study and included the first female to receive R327 via IV administration. Assessments are being conducted to determine the effectiveness of R327’s antibacterial activity in the urine of dosed participants.

Full details on the trial can be found on anzctr.gov.au under the Trial ID ACTRN12623000448640.

The Company believes the results from this current study will showcase the potential of R327 as a positive therapeutic against any bacteria, including Gram-positive and/or Gram-negative bacteria, in addition to ESKAPE pathogens in patients in future studies.