Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has received Human Research Ethics Committee (HREC) approval to begin its Phase I intravenous (IV) clinical trial evaluating the safety and pharmacokinetics of its lead compound, RECCE® 327 (R327).
Recce is pioneering the development and commercialisation of a new class of synthetic anti-infectives designed to address the urgent global health threat posed by antibiotic-resistant superbugs and emerging viral pathogens.
The Phase I clinical trial for R327 is an IV, ascending-dose, randomised, placebo-controlled, parallel, double-blind single-dose study, evaluating the safety and pharmacokinetics (absorption, distribution, metabolism, and excretion) of R327 in healthy male subjects.
“Momentous achievement”
“Receiving human ethics approval is a momentous achievement for Recce and the clinicians seeking effective treatments to combat antibiotic-resistant bacteria,” Recce Pharmaceuticals chairman Dr John Prendergast said.
“This milestone is a significant representation of the dedication and diligence our clinical and research team put into their day-to-day work as we continue to build on our clinical and commercial potential.”
Shares have been as much as 6.5% higher to A$0.985 intraday while the company's market cap pre-open was approximately A$160.8 million.
About 80 patients in total will be enrolled, with R327 to be administered as a single dose via a 1-hour IV infusion across eight dose cohorts of 10 people each. Dosage will start at 50mg of R327 (eight subjects) or placebo (two subjects).
The trial will involve inpatient treatment over the first two days with follow up visits to the clinic at Day 7.
A new class of anti-infectives
R327 represents a new class of broad-spectrum anti-infectives. It was recently added to The Pew Charitable Trusts’ list of Non-traditional Products in Development to Combat Bacterial Infections. Of 36 candidates in clinical development, R327 is the only synthetic polymer drug candidate.
It is also the only clinical-stage antibiotic for the indication of sepsis globally.
First patient dosing is on track for December 2021 at Adelaide’s CMAX clinical trial facility. Data from the first cohort of patients is expected to be available within the calendar year, with readouts to be made available in the interim and the completion of the clinical trial expected within about 12 months.
Ethics approval for this clinical trial represents confirmation that Recce has completed the necessary pre-clinical safety and efficacy testing of R327 required to commence IV human clinical trials and runs in addition to a present Phase I/II Burns Wound Infection study (topical) at Fiona Stanley Hospital.
Drug pipeline
