Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF), which is developing a new class of synthetic anti-infectives, welcomes the news that its candidate RECCE® 327 (R327) returned a good safety and tolerability profile among 10 healthy male subjects.
The Phase 1 intravenous clinical trial’s sixth cohort was dosed at 4,000 milligrams – an 80-fold increase on the first cohort’s 50-milligram dose.
Investors have also welcomed the news, with RCE securities as much as 30.01% higher to A$0.735.
Only new class of antibiotic
According to PEW Charitable Trusts 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.
An independent safety committee is expected to conduct a review of the data and a recommendation can then be issued to start recruiting for the seventh cohort of the trial.
CEO James Graham said: “We are pleased with these data which build on previous results and strongly support the potential of RECCE® 327 as a new treatment option for patients with sepsis.
“We look forward to continuing to work with the independent safety committee and further evaluating RECCE® 327’s safety and tolerability profile in additional cohorts.”
About the trial
The Phase 1 trial is an ascending dose, randomised, placebo-controlled, parallel, double-blind, single-dose study being conducted at Adelaide's CMAX clinical trial facility.
The study is evaluating the safety and pharmacokinetics of R327 in around seven to 10 healthy subjects per dose, across eight sequential dosing cohorts. The study is on track to have all Phase 1 dosing complete by the second quarter of 2022.