Recce Pharmaceuticals (ASX:RCE) has announced that its Phase 1/2 clinical trial evaluating R327 at faster infusion rates has successfully dosed its first cohort of male and female subjects.
The company, which is developing a new class of synthetic anti-infectives, said there had been no serious adverse events.
The company said the cohort was all dosed at two faster infusion rates of 2,500mg and included the first female to receive R327 via intravenous administration. It said this is more rapid than that used in its completed 80-subject Phase 1 study.
“Assessments are being conducted to determine the effectiveness of R327’s antibacterial activity in the urine of dosed participants,” it said.
Recce Pharmaceuticals’ De Alan Dunton said, “In Recce’s completed 80-subject Phase 1 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.”
Dr Dunton continued, “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 per cent of UTI patients have bacteria in their urine, which are now resistant to two or more antibiotics1. Furthermore, UTI infections are the foundational contributor to more than 30 per cent of sepsis cases globally.”
