Recce Pharmaceuticals (RCE) last year confirmed the safety of its R327 antibiotics treatment for human use, and now it’s working to confirm the treatment’s efficacy in the patient population.
R327 is the world’s first breakthrough antibiotic candidate in nearly two decades, and it’s well along its journey to market.
The next phase of trials can now proceed after Recce received Human Research Ethics Committee approval.
Microbiology-trained Executive Chairman John Prendergast said earlier trials had guided Recce to focus on R327’s efficacy in tackling urinary tract infections (UTIs).
“We’ve discovered through the course of our phase I healthy volunteer study that the drug actually concentrates in the urine,” Dr Prendergast said.
“The drug is telling us where to go. This provides us with a ready opportunity to study UTI infections, because the drug is actually there.”
Recce’s biotech expert and non-executive director Alan Dunton said 70 per cent of sepsis cases stemmed from UTIs.
“We have not found a bug yet to which this drug is resistant, so we’re very excited about that,” Dr Dunton said.
“This is the first new type of anti-infective product in about 20 years. This is completely novel — its mechanism of action is brand new.
“It provides an opportunity to treat a broad spectrum of infections — bacteria, virus, micro bacteria that are responsible for tuberculosis.
“The drug works very fast — albeit in animal models — within 10 minutes it has an effect on the infection itself. Given that information, this is going to be a very important drug for clinicians to use.”
There’ll be 20 participants in Recce’s next intravenous clinical trials, and R327 will be administered intravenously at faster rates than tested before, within 30 minutes and 15 minutes, to determine the optimal administration rate and therapeutic potential.
The company is well placed to fund the trials in the first half of the year, having recently received $6.21 million in research and development (R&D) rebate payments.
Dr Prendergast said big pharmaceutical companies were closely watching the company’s progress.
“We have already established several relationships with major pharmas that are now following us very closely,” he said.
US-based Dr Dunton and Dr Prendergast are visiting Australia to meet with trial partners the Recce board and investors.
R327 has already taken a decade of development, and Dr Prendergast said it could be transformational.
“The resistance crisis is continuing to grow, and so that’s the one thing that we are truly hoping for — to be able to transform patients’ lives that are really put in jeopardy because they have serious life-threatening infections,” he said.
The company continues to trial topical applications for the treatment of burns.
Recce Pharmaceuticals is trading at 70 cents at 11:22 am AEST.