Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) is trading higher after receiving positive data from a Phase I intravenous clinical trial of RECCE® 327 (R327), demonstrating safety and tolerability amongst nine healthy male subjects in the first cohort.
Based on clinical data readouts, an independent safety committee has approved a threefold increase (from 50mg to 150mg) among 7-10 healthy subjects in the second cohort, with subjects expected to be dosed today at Adelaide's CMAX clinical trial facility.
According to PEW Charitable Trust’s global antibiotic pipeline review, R327 is the only clinical-stage new class of antibiotic in the world being developed for sepsis, the largest unmet medical need in human health.
“Significant progress”
Recce CEO James Graham said: “R327 continues to make significant progress in the clinic both in this Phase I intravenous trial and a parallel Phase I/II topical trial on patients with serious burn wound infections.
“We’re pleased to see R327 (50mg) tolerated as an intravenous infusion in Cohort One subjects.”
In response to these results, investors have sent shares as much as higher 6.8% to $1.10 intraday while the company's market cap is approximately A$189.43 million.
Demonstrated safety and tolerability
R327 was shown to be safe and well-tolerated at the 50mg dose with no clinically significant changes in vital signs, clinical, adverse events or laboratory parameters.
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.
Notably, the 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.
The study is on track to have all Phase I dosing complete by the second quarter of 2022.
About Recce Pharmaceuticals
Recce Pharmaceuticals is developing new classes of synthetic anti-infectives designed to address the urgent global health problems of antibiotic-resistant superbugs and emerging viral pathogens.
The company’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; and
- RECCE® 529 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.
Recce’s antiinfective pipeline seeks to exploit the unique capabilities of its technologies targeting synergistic, unmet medical needs.