Broad-spectrum synthetic antibiotics developer Recce Pharmaceuticals Ltd (ASX: RCE) has formalised a Phase I clinical trial agreement to conduct a first-in-human study of its lead compound RECCE 327 in 40 healthy subjects.
The Phase I clinical study of RECCE 327 will be conducted at a specialised clinical trial facility in Australia, independent of the hospital system.
Recce Chairman, Dr John Prendergast, said this initiative seeks to ensure continuity of the independent study and not add to infectious disease pressures for beds around the country. The first patients in this study are expected to be dosed in the second half of 2020.
The randomised, double blind, placebo-controlled single-ascending dose study will involve up to 40 healthy subjects to evaluate safety, tolerability, pharmacokinetic and pharmacodynamic properties of RECCE 327; clinical start-to-completion expected within 12 months from now, with regular interim data updates.
“The formalisation of the clinical trial agreement is a major milestone towards advancing RECCE 327 through the clinic,” Dr Prendergast said.
“It brings us a step closer to addressing the rising rates of antibiotic resistance, with a synthetic antibiotic that has shown extraordinary preclinical potential to fight off a broad range of bacterial infections, including superbug forms, even with repeated use.”
RECCE 327 is a broad-spectrum synthetic antibiotic formulated using synthetic polymer technology to treat blood infections and sepsis derived from Escherichia coli and Staphylococcus aureus bacteria.
Dr Prendergast said it is the first new class of antibiotic in over three decades and is effective against both Gram-negative and Gram-positive bacteria, with a novel universal mechanism of action that sees its antibacterial potency continue even with repeated use.
Sepsis is a potentially life-threatening condition mostly caused by bacterial infection in the blood and results in the immune system mounting a hyperactive inflammatory response to the bacteria/toxins, which can quickly lead to tissue and organ injury, and ultimately death.
Dr Prendergast said there are currently no drug therapies available specifically targeted for the treatment of sepsis, and therefore there is a desperate and unmet medical need for new, safe and efficacious treatments.
According to the World Health Organisation, sepsis is estimated to affect more than 30 million people worldwide every year, potentially leading to six million deaths.