Recce Pharmaceuticals has reported that the Independent Safety Committee recommended advancement of the Phase I clinical trial of RECCE 327 (R327).
The latest development comes after the committee analysed trial data from ten healthy participants who received intravenous (IV) doses of R327, which showed favourable safety and tolerability.
The committee further recommended progressing the trial to Cohort 4 to analyse a 1,000mg IV dose of R327.
An intravenous and topical treatment, RECCE 327 is being developed to treat serious and possibly serious infections caused by Gram-positive and Gram-negative bacteria including their superbug forms.
The randomised, ascending dose, placebo-controlled, single-dose, parallel, double-blind trial will analyse the safety and pharmacokinetics of R327 in seven to ten healthy participants per dose, across eight dosing cohorts of 50-16,000mg.
It is being carried out at the CMAX clinical trial facility in the Australian city of Adelaide.
Subject recruitment to Cohort 4 commenced with all subjects to be dosed with IV 1,000mg R327 in a week.
Recce noted that the trial is on track to conclude dosing in Phase I trial by the second quarter of this year.
Recce Pharmaceuticals CEO James Graham said: “Recommendation to start IV dosing of Cohort 4 (R327 I.V.; 1,000mg) is a wonderful endorsement for the compelling safety and tolerability profile demonstrated among 10 subjects of Cohort 3.”
The company focuses on developing a new class of synthetic anti-infectives that can tackle the crucial health problems of antibiotic resistant superbugs and emerging viral pathogens across the globe.
Apart from R327, the anti-infective pipeline of Recce comprises two broad-spectrum, synthetic polymer anti-infectives, RECCE 435 and RECCE 529.
RECCE 435 and RECCE 529 are oral therapies intended for bacterial and viral infections, respectively.