Synthetic anti-infective company Recce Pharmaceuticals (ASX:RCE) has provided an update on its Phase I/II clinical trial for the treatment of burn wound infections.
The trial, which is sponsored by the West Australian Health department at Fiona Stanley Hospital, is assessing the safety and efficacy of RECCE 327 (R327) in patients with infected burn wounds.
Study Investigator Dr Ed Raby said, “We are highly encouraged by the initial success of R327 in this topical Phase I/II trial. Patients with burn wounds often suffer severe bacterial infections that are painful, prevent wound healing and can even result in death if not properly treated. Because many of these bacteria are resistant to most available drugs, we are pleased by the potential in R327 offering a treatment option for patients in need.”
The company said the characterisation of swabs from participant burn wounds prior to treatment with R327 identified a wide range of pathogenic bacteria including gram-positive (Staphylococcus aureus and Staphylococcus lugdunensis) and gram-negative (Pseudomonas aeruginosa, klebsiella pneumoniae, morganella morganii, oroteus vulgaris, proteus mirabilis) bacteria. Some of these are defined as multi-drug resistant and categorised as difficult to treat due to biofilms.
"Clinicians have reported visible reductions in bacterial infection within the first 24 hours of R327 treatment among patients treated to date," said the company.
"Patients with acute infected wounds have indicated a complete clinical response, requiring no further treatment. As a result, clinicians have adopted a significantly shorter five-day treatment protocol. Patients with chronic or significant surface area wounds see a similar outcome by day seven. Treatment protocols for both groups of patients were initially proposed to comprise a 14-day period."
<p">"As is common in therapeutic activity on sensitive wound surfaces, patients noted a minor, brief stinging sensation as the solution reached the area of infection, which appeared to subside in line with reduction in bacterial loads. No adverse effects or abnormalities have been reported among patients."
The study is ongoing with target patient enrolment and treatment expected in early 2022.
Recce Pharmaceuticals CEO James Graham added, “We are pleased with the progress of our lead compound, R327 in patients harbouring serious burn wound infections. This initial update builds upon strong pre-clinical data demonstrating fast and efficient killing activity against common and problematic bacterial strains, and we are excited for the potential of R327 in the clinic. We look forward to updating shareholders of further human clinical data points as this trial progresses.”