Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has been given the green light by an independent safety committee for the next cohort dosing of RECCE® 327 and will be permitted to dose participants at a faster infusion rate of 15 minutes, involving 3,000 milligrams administered intravenously.
This development marks a significant stride for the treatment of urosepsis, because of the importance of arresting its progress as early as possible.
The committee's unanimous agreement that R327 is safe and well tolerated in male and female subjects at the previous infusion rate of 30 minutes adds to the positive outlook.
The next cohort of subjects has already been recruited and dosing is set to commence shortly.
Speed is key in UTI intervention
Recce Pharmaceuticals has previously administered R327 at both a one-hour infusion rate and a 30-minute infusion rate of 3,000 milligrams, with both approaches deemed safe and well tolerated.
UTIs account for a staggering 30% of all sepsis infections.
The significance of rapid infusion of antibiotics, typically administered over 30 minutes, lies in the savings in nursing time, cost reduction and enhanced safety.
In outpatient settings, intravenous rapid antibiotic infusion can impact patient treatment rates, wait times and the duration of patient infusion.
CEO James Graham said: “We are pleased to receive the Independent Safety Committee’s approval to commence dosing of R327 at an even faster infusion rate (15 minutes) than what has been already administered in previous doses (one-hour infusion rate and a 30-minute infusion rate).
“This data reaffirms R327’s potential first-line treatment for patients suffering from life-threatening infections such as urosepsis or sepsis – as the mortality of sepsis increases by 6-8% for every hour that treatment is delayed.”
This development aligns with the 2021 Surviving Sepsis Campaign (SCC) guidelines, which strongly recommend the initiation of intravenous broad-spectrum antibiotics as soon as possible, preferably within an hour of sepsis recognition.
About Recce Pharmaceuticals
Recce Pharmaceuticals is at the forefront of developing a new class of synthetic anti-infectives to combat antibiotic-resistant superbugs and emerging viral pathogens.
The company's anti-infective pipeline includes three patented, broad-spectrum, synthetic polymer anti-infectives: RECCE® 327, RECCE® 435, and RECCE® 529.
These innovative therapies have the potential to overcome the challenges posed by bacterial and viral mutations that have rendered traditional antibiotics less effective.
RECCE® 327 has received Qualified Infectious Disease Product designation from the FDA, Fast Track Designation, and 10 years of market exclusivity post-approval.
It is the only synthetic polymer and sepsis drug candidate in development recognised by The Pew Charitable Trusts Global New Antibiotics in Development Pipeline. Clinical testing is ongoing to evaluate its safety and efficacy.
Recce Pharmaceuticals wholly owns its automated manufacturing, supporting ongoing clinical trials aimed at addressing unmet medical needs.