A Phase I/II clinical trial of Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF)’s topical application against burn wound infections, RECCE® 327 (R327), has demonstrated a visible reduction in bacterial infection.
R327, one of the first new classes of antibiotics in more than 30 years, has a universal mechanism that allows its compounds to continuously kill bacteria and multi-drug resistant superbugs. This includes deadly bacterial pathogens identified by the World Health Organisation (WHO) as major threats to human health.
Clinician reports from the phase I/II topical clinical trial noted a visible reduction in bacterial infection within the first 24 hours of R327 treatment.
Broad-spectrum activity
The treatment demonstrates broad-spectrum antibiotic activity against both gram-positive and gram-negative pathogens, which are listed on the WHO Priority Pathogen list of antibiotic-resistant bacteria and defined as multidrug-resistant and difficult to treat.
All patients treated with R327 showed good indications of safety and tolerability to the compound, with no serious adverse events reported among patients.
The success of the Western Australian Government-sponsored study has led to multiple opportunities such as the commencement of a Phase I/II Diabetic Foot Infection trial — the largest in Australia, the use of RECCE® 327G (R327G) as a topical agent on patients under the TGA Special Access Scheme – Category A, and interest from military organisations for the use of R327 and R327G.
Recce has now concluded recruitment for Stage 1 of the investigator-led clinical trial but recruitment has been limited due to the Fiona Stanley Hospital Burns Unit finding it difficult to recruit appropriate patients. Many potential recruits did not meet protocol requirements of having no prior antibiotic treatment prior to enrolment, due to COVID protocols that resulted in preventative, systemic, antibiotic infection control practices.
In order to access a greater patient population, clinical investigators are now preparing a new protocol in line with a next stage ‘head-to-head’ investigation. A stage 2 clinical trial is expected to be a randomised ‘head-to-head’ in patients with infected burn wounds, where R327G treatment is compared to existing treatment standard of care.
Recce CEO James Graham said, “We thank the West Australian Government for sponsoring this investigator-led topical burn wound infection trial.
"The patient data received has paved the way to advance this new class of anti-infective as a topical application against deadly bacterial pathogens and a broad range of infectious diseases beyond. We look forward to launching Stage 2 as this study has facilitated.”