Recce Pharmaceuticals Ltd (ASX:RCE, FSE:R9Q) (the Company), the company developing a new class of synthetic anti-infectives, is pleased to report that in cohort seven of a Phase 1 clinical trial, RECCE® 327 (R327) intravenously dosed at 6,000mg (a 120-fold increase from cohort one at 50mg) over a 1-hour infusion demonstrated no serious adverse effects among 10 healthy male subjects.
An Independent Safety Committee is reviewing cohort seven data and is expected to recommend the initiation of cohort eight. Recce reports 6,000mg as broadly efficacious in previous animal studies with Phase 2 protocol under development.
“We are thrilled to have completed dosing of 6,000mg (6 grams) via a 1-hour I.V. infusion in our Phase 1 clinical trial,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals Ltd. “Achieving a 120-fold increase from cohort one at 50mg with anticipation to soon initiate cohort 8 continues to build the safety and tolerability profile of R327 as a potential new treatment option.”
The Phase 1 trial is an ascending dose, randomized, placebo-controlled, parallel, double-blind, single-dose study conducted at Adelaide’s CMAX clinical trial facility. The study is evaluating the safety and pharmacokinetics of R327 in 7-10 healthy subjects per dose across eight sequential dosing cohorts (Trial ID ACTRN12621001313820).
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.1