Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has successfully dosed its first cohort of both male and female subjects with RECCE 327 (R327) as part of its Phase I/II UTI (urinary tract infection) clinical trial, with no serious adverse events reported.
The cohort were all dosed at two faster infusion rates of 2,500mg and included the first female to receive R327 via I.V. administration – more rapid than that used in Recce’s completed 80-subject Phase I study.
Assessments are being conducted to determine the effectiveness of R327’s antibacterial activity in the urine of dosed participants.
Killing E. coli within minutes
Recce non-executive director of pharmaceuticals and medical monitor of the clinical trial Alan W Dunton, MD said: “In Recce’s completed 80 subject Phase I study of R327 administered as a 1-hour infusion, data showed that R327 concentrated in the urine by at least 15-fold compared to plasma concentrations.
“Peak concentrations of R327 in urine noted in this study have been shown in vitro 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.
“Furthermore, UTI infections are the foundational contributor to more than 30% of sepsis cases globally.
“The company believes the knowledge from this current study should raise the probability of R327 having a positive therapeutic effect against any bacteria (grampositive and/or gram-negative, including ESKAPE pathogens) in patients in future studies.”