Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has demonstrated good safety and tolerability in the fifth cohort of a phase 1 clinical trial investigating the safety of Recce’s synthetic anti-infective RECCE ®327 (R327), clearing the way for the next cohort to begin dosing.
In cohort 5, 10 healthy male subjects were given 2,000 milligrams intravenously, and demonstrated suitable tolerability for the independent safety committee to approve dosing the sixth cohort at 4,000 milligrams: an 80-fold increase from the 50 milligrams given to cohort 1.
Cohort 6 subjects have already been recruited and dosing is underway.
“Compelling safety and tolerability profile”
“This data builds on previous cohorts and validates RECCE® 327’s compelling safety and tolerability profile, with the potential to serve as a solution for patients with sepsis,” Recce Pharmaceuticals CEO James Graham said.
“We are greatly encouraged by this progress and moved quickly to commence dosing of Cohort 6, evaluating R327 in high doses of 4,000 milligrams.”
This 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 designed to evaluate the safety and pharmacokinetics – absorption, distribution, metabolism, and excretion – of R327 in seven to 10 healthy subjects per dose, across eight sequential dosing cohorts of 50-16,000 milligrams.
According to PEW Charitable Trusts global antibiotic pipeline review, R327 is the only clinical-stage antibiotic being developed for sepsis, one of the largest unmet needs in human health globally.