Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has completed dosing of the first subjects at the highest concentration of 3,000 milligrams of RECCE® 327 at a faster infusion rate of 15 minutes, administered intravenously.
The infusion rate, the fastest at a high concentration to date, was permitted by an independent safety committee last month after it unanimously concluded that R327 is safe and well tolerated in male and female subjects at an infusion rate of 3,000 milligrams over 30 minutes.
The remaining subjects in the company’s Phase I/II UTI/Urosepsis Rapid Infusion Clinical Trial will be dosed in the coming days.
UTIs account for a staggering 30% of all sepsis infections.
Another milestone
“To be dosing at twice the speed of the last cohort to 3,000mg over 15 minutes via intravenous administration is a testament to the safety and tolerability profile of R327,” Recce Pharmaceuticals chief executive officer James Graham said.
"Another important clinical milestone for the company, as we push towards achieving R327’s potential as a first-line treatment for the millions of patients suffering from UTI/Urosepsis each year.”
About the company
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 owns its automated manufacturing, which supports ongoing clinical trials aimed at addressing unmet medical needs.