Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has picked Adelaide’s CMAX Clinical Research as the independent trial facility to conduct its Phase 1/2 intravenous (IV) clinical trial of its lead pipeline candidate R327 in healthy male and female subjects.
World-leading research in South Australia
CMAX conducts successful world-leading research for local and international clients, specialising in a range of early-phase trials and first-in-human studies, and the partnership builds on the success of recent Phase 1 IV safety and tolerability studies.
The trial will evaluate and assess R327 as an intravenous dose at faster infusion rates – 15 minutes and 30 minutes – across three cohorts of around 12 participants each, with first subjects expected to be dosed in the first quarter of 2023.
Plasma and urine will be collected at various time points during and following dosing to evaluate R327 concentrations and antibacterial effect in the urine on various bacterial strains.
First-line, broad-spectrum treatment
R327 is conceived of as a fast, first-line UTI treatment. The results of this Phase 1/2 trial will support its progress as a broad-spectrum anti-infective across all types of UTIs, including simple, complicated and recurring.
A Phase 2 in UTI patients is expected to be initiated in the second half of the year.
An independent in-vitro study demonstrated that relatively low concentrations of R327 in human urine was able to have a fast (near minutes) effect on E. coli bacteria, which is responsible for approximately 90% of UTIs.
It also reduced the bacteria to irreversibly low levels, meaning that bacteria could not be ‘washed out’ and regrown.
Further, a recent Phase 1 study demonstrated R327 could be administered safely – and achieve concentrations in the urine which were 20-fold those achieved in plasma.
A healthy bladder is one free from bacteria, and the opportunity for R327, clearly identified at the typical site of infection in such high concentrations, strongly supports a potential therapeutic application.
30% of sepsis starts with UTIs
There are no drug therapies currently approved for the treatment of sepsis. UTIs are responsible for about 30% of all sepsis infections, defined as ‘Urosepsis’.
R327’s potential as a treatment option across the patient infectious disease journey, from underlying infection to septic state, positions it for therapy in this area of unmet medical need.
Recce Pharmaceuticals CEO James Graham said: “We are thrilled to be building upon the successes of a recent Phase 1 study with the team at CMAX.
“The opportunity of showcasing R327’s potential to change the treatment paradigm for patients suffering from serious infections strengthens its position as a fast-acting, broad-spectrum anti-infective.”
Principal investigator Dr Nicholas Farinola said: “We are highly encouraged by the safety and tolerability of R327 throughout the Phase 1 trial and are committed to supporting ground-breaking medical research.
“A high concentration of R327 in the human bladder (some 20-fold) suggests R327 may be used as a broader anti-infective treatment in urosepsis.”