Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has received more positive safety data from its Phase 1 anti-infectives trial.
The healthcare stock dosed 10 healthy male subjects from the trial’s seventh cohort with no serious adverse effects.
During this cohort, Recce dosed participants with 6,000 milligrams of its flagship RECCE® 327 drug candidate — a 120-fold increase on the 50 milligrams given to participants in the trial’s first cohort.
In the past, animal studies have demonstrated the 6,000-milligram dose’s efficacy, but Recce believes more studies are needed to fully determine its value in human subjects.
Now, an independent safety committee is reviewing the data, and it’s expected to recommend that Recce dose an eighth cohort.
Preparations are already well underway for the next phase of studies, and Recce will keep the market updated on any new data.
A potential new class of anti-infectives
Recce CEO James Graham said: “We are thrilled to have completed dosing of 6,000 milligrams (6 grams) via a one-hour intravenous infusion in our Phase 1 clinical trial.
“Achieving a 120-fold increase from cohort one with anticipation to soon begin a cohort eight continues to build the safety and tolerability profile as a potential new class of anti-infectives.”
The fine print
Recce’s Phase 1 trial is an ascending dose, randomised, placebo-controlled, parallel, double-blind, single-dose study. It’s currently being conducted at Adelaide's CMAX clinical trial facility.
Essentially, the study evaluates the safety and pharmacokinetics of Recce 327 in seven to 10 healthy subjects per dose, across eight sequential dosing cohorts.
According to the PEW Charitable Trusts global antibiotic pipeline review, Recce 327 is the only clinical-stage new class of antibiotic in the world being developed for sepsis — the largest unmet medical need in human health.