Recce Pharmaceuticals provides an update on its progress towards the start of human trials of its lead compound RECCE 327, for the treatment of sepsis, including a simple clinical trial design
RECCE 327 is being developed as a new class of antibiotic, designed to address the urgent global health issue of growing antibiotic resistance (superbugs).
It was awarded Qualified Infectious Disease Product (QIDP) designation in late-2017 as part of the US Generating Antibiotic Incentives Now (GAIN) Act, labelling it for Fast Track Designation, plus 10 years of market exclusivity post approval.
Submission of its recent data package to the US Food & Drug Administration (FDA), and close interaction with the FDA facilitated by this designation, has enabled Recce in conjunction with its FDA advisory partners, to develop a simple protocol, subject to FDA approval, for a first-in-human Phase Ia clinical trial.
International clinical trial groups that may be involved in trials of RECCE 327 are evaluating a proposed randomised, double-blind, placebo-controlled Phase Ia study that would seek to evaluate safety and tolerability in 44 adult participants given a single ascending dose of RECCE 327, administered intravenously as an infusion, at a uniform rate for 24 hours under medical supervision.
Reportable human data from the Phase Ia trial would be expected to be available within months of starting the study.
Based on data from the Phase Ia study, an expanded Phase Ib study would soon follow.
Both Phase Ia and Ib trial protocols are designed to be cost and time efficient, with both are expected to be completed within 12 months of the start of a Phase Ia study.
Since meeting with FDA in May, Recce has continued its data driven focus, with the view to expanding the understanding of its new class of broad spectrum antibiotic technology that has been demonstrated to overcome the typical development of antibiotic resistance by bacteria exposed to traditional drugs.
Recce Pharmaceuticals Executive Chairman, Dr Graham Melrose, said: “Our continued encouraging preclinical advancements support the current investigation into materialising a clinical protocol as we look ahead to substantiate our next stages of business.”