Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has demonstrated a good safety and tolerability profile amongst seven healthy male subjects from its third cohort of Phase I clinical trial evaluating subjects intravenously dosed with RECCE® 327 (R327).
The company is developing new classes of synthetic anti-infectives designed to address the urgent global health problems of antibiotic-resistant superbugs and emerging viral pathogens.
Notably, R327 was indicated to be safe and well-tolerated at 500mg with no clinically significant changes in vital signs or adverse events.
Looking ahead, the study is on track to have all Phase I dosing complete by 2022 with cohort four recruitment already underway.
“Wonderful milestone”
Recce CEO James Graham said: “Indications of R327 being safe and well tolerated at 500mg IV is a wonderful milestone for the company.
“These results are an excellent outcome for this clinically-invasive method of administration, with a few additional participants to strengthen a compelling safety profile and serves well for regulatory and synergistic program potential.”
Phase I trial
The Phase I trial is an ascending dose, randomized, placebo-controlled, parallel, double-blind, single-dose study being conducted at Adelaide's CMAX clinical trial facility.
This study is evaluating the safety and pharmacokinetics of R327 in 7-10 healthy subjects per dose, across eight sequential dosing cohorts of 50-16,000mg (Trial ID ACTRN12621001313820).
Recce is recruiting three additional subjects to maximise the key data set, which is expected within two weeks.
Furthermore, an independent safety committee will review the study at completion.
Anti-infective pipeline
Recce’s anti-infective pipeline includes three patented, broad-spectrum, synthetic polymer anti-infectives.
RECCE® 327 as an intravenous and topical therapy that is being developed for the treatment of serious and potentially life-threatening infections due to Gram-positive and Gram-negative bacteria including their superbug forms.
RECCE® 435 as an orally administered therapy for bacterial infections whicle RECCE® 529 is for viral infections.
Through their multi-layered mechanisms of action, Recce’s anti-infectives have the potential to overcome the hypercellular mutation of bacteria and viruses – the challenge of all existing antibiotics to date.