Recce Pharmaceuticals has selected CMAX Clinical Research in South Australia as the independent trial facility for a Phase I/II intravenous (IV) trial of RECCE 327 (R327) to treat urinary tract infections (UTI).
The Phase I/II trial has been designed for assessing and evaluating R327 as an IV dose at fast infusion rates of 15 to 30 minutes across three cohorts of nearly 12 participants, with first participants anticipated to be dosed in the first quarter of this year.
In the trial, plasma and urine from the participants will be collected at various time points during and after dosing.
These samples will be used for assessing the concentrations and antibacterial effect of R327 in the urine on various bacterial strains.
Recce stated that the data from the trial will support R327’s advancement as a broad spectrum anti-infective across all types of UTIs, including simple, complicated, and recurring.
A Phase II trial in UTI patients is anticipated to be commenced in the second half of the year.
In a Phase I study, R327 was found to be given safely.
Recce Pharmaceuticals CEO James Graham said: “We are thrilled to be building upon the successes of a recent Phase I 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.”
IV and topical therapy R327 is being developed to treatment serious and potentially life-threatening infections that are caused due to Gram-positive and Gram-negative bacteria, including their superbug forms.