Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has the green light from the Human Research Ethics Committee (HREC) to start its Phase 1/2 intravenous (IV) clinical trial of its lead pipeline compound RECCE® 327 (R327) in healthy male and female subjects.
The trial will look at assessing R327 as an intravenous dose at faster infusion rates (15 minutes and 30 minutes) across roughly 12 participants in three cohorts.
During and following dosing, plasma and urine will be collected to evaluate R327’s antibacterial and concentration effects.
First dosing on track
First patient dosing is on track for the first half of 2023 at Adelaide’s CMAX clinical trial facility and the trial is expected to take around two months.
The results of this Phase 1/2 trial will guide a Phase 2 pre-sepsis trial in patients with uncomplicated or recurrent urinary tract infections (UTIs) with optimised dose levels and infusion rates.
UTIs are responsible for approximately 30% of all sepsis infections, also known as urosepsis.
Administering the drug at faster rates, especially within a GP setting or an acute patient setting, is critical – antibiotics need to be administered faster to treat the infection.
The 2021 Surviving Sepsis Campaign (SCC) guidelines strongly recommend that the administration of intravenous broad-spectrum antibiotics should be initiated as soon as possible, preferably within an hour of sepsis recognition.
"Exciting time"
Recce Pharmaceuticals non-executive director and medical monitor of the clinical trial Dr Alan Dunton said: “This is a very exciting time in the company and a significant step in the right direction to provide a potential treatment for those suffering from uncomplicated and recurring UTIs, including those that progress to urosepsis.
“This approval recognises the dedication and perseverance of all those involved, as we look to evaluate R327 as a broader anti-infective treatment.”
Following HREC approval of this trial, the company has now submitted registration to the Australia New Zealand Clinical Trials online registry.
About Recce Pharmaceuticals
Recce Pharmaceuticals is working on new classes of synthetic anti-infectives designed to address the urgent global health problems of antibiotic-resistant superbugs and emerging viral pathogens.
Recce’s anti-infective pipeline includes three patented, broad-spectrum, synthetic polymer anti-infectives:
- RECCE® 327 as an intravenous and topical therapy that is being developed for the treatment of serious and potentially life-threatening infections due to gram-positive and gram-negative bacteria including their superbug forms;
- RECCE® 435 as an orally administered therapy for bacterial infections; and
- RECCE® 529 for viral infections.
Recce wholly owns its automated manufacturing, which is supporting present clinical trials. Recce’s anti-infective pipeline seeks to exploit the unique capabilities of its technologies targeting synergistic, unmet medical needs.