Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF), an Australian biotech committed to developing the next generation of synthetic anti-infectives, has successfully wrapped up dosing of its latest cohort in the Phase 1/2 UTI/Urosepsis clinical trial.
Results expected soon
The trial, which is evaluating RECCE® 327 (R327) at rapid infusion rates, achieved its highest dosage to date, administering 4,000mg of R327 over 20 minutes to six human subjects.
Administering antibiotics through rapid intravenous infusions has proven to be a safe and effective method, significantly impacting patient treatment, reducing wait times, and alleviating nursing workloads worldwide.
An independent safety committee will review the cohort data, with preliminary results expected in the coming weeks.
This trial has already identified minimum inhibitory concentration (MIC) activity against bacteria in existing clinical samples, serving as a dose optimisation exercise for regulatory purposes.
New milestone
CEO James Graham said: "We have successfully reached a new milestone in this trial by administering a 4,000mg dose over a fast 20-minute infusion to all subjects, the highest dosage achieved so far in this clinical trial.
“This is a significant step forward in bringing us closer to establishing R327 as a leading treatment for those suffering from UTI/Urosepsis."
The data from this trial is expected to pave the way for a Phase 2 UTI/Urosepsis efficacy trial, potentially establishing R327 as a frontline treatment.
The full efficacious potential of R327 via intravenous administration will be available upon completion of this clinical trial in line with the study protocol.
About Recce
Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) is developing a new class of synthetic anti-infectives designed to address the urgent global health problems of antibiotic-resistant superbugs and emerging viral pathogens.
Recce’s anti-infective pipeline includes three patented, broad-spectrum, synthetic polymer anti-infectives: RECCE® 327 (R327) for intravenous and topical therapy, RECCE® 435 (R435) as an orally administered therapy for bacterial infections and RECCE® 529 (R529) for viral infections.
Recce’s anti-infectives have the potential to overcome the resistance mechanisms deployed by bacteria and viruses, a significant challenge facing existing antibiotics.
The World Health Organization (WHO) has recognised Recce’s efforts to combat antimicrobial resistance by adding R327, R435, and R529 to its list of antibacterial products in clinical development for priority pathogens.
The US Food and Drug Administration (FDA) granted R327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act, providing Fast Track Designation and 10 years of market exclusivity post-approval.
R327 is also included on The Pew Charitable Trusts’ Global New Antibiotics in Development Pipeline as the sole synthetic polymer and sepsis drug candidate in development.
Recce wholly owns its automated manufacturing, supporting current clinical trials.