SYDNEY—Recce Pharmaceuticals Ltd, a company focused on developing new classes of synthetic anti-infectives, has announced a formalized agreement with Fiona Stanley Hospital for a Phase 1/2 clinical trial to assess the potential of RECCE 327 — Recce’s broad-spectrum antibiotic for the treatment of topical burn wound infections.
“We look forward to working with the world-leading team at Fiona Stanley Hospital in advancing new treatment options for burns victims at increased risk of infection from multidrug resistant organisms,” said Dr. John Prendergast, non-executive chairman for Recce Pharmaceuticals. “Based on promising results from preclinical studies, we believe RECCE 327 has potential to make a significant impact in treating infections, which continue to pose a challenge to the long-term survival of patients in burns units.”
The Phase 1/2 topical study will enroll up to 30 patients, and will be held at the Fiona Stanley Hospital Burns Unit in Perth, Australia. The study plans to assess the safety and efficacy of RECCE 327 as a broad spectrum spray-on antibiotic for patients with Gram-positive and Gram-negative bacterial burn wound infections, and will expand to a comparative effectiveness study, based on the data. Over 14 days, 10 patients will receive RECCE 327 daily, while 20 patients will receive treatment three times per week. The first patients are expected to be dosed in the first quarter of 2021.
Trial investigators include Dr. Edward Raby, clinical microbiologist and infectious diseases expert at Royal Perth and Fiona Stanley Hospitals; Dr. Chris Heath, head of Infectious Diseases at Fiona Stanley Hospital; and Professor Fiona Wood, director of the State Adult Burns Unit at Fiona Stanley Hospital. Wood is an internationally renowned burns surgeon, known for pioneering the development of spray-on skin technology.
“Antibiotic resistant infection is a major issue after burns injuries. Our team is keen to identify and add new treatments with the potential to overcome antibiotic resistance and improve patient’s lives,” Raby stated. “We look forward to evaluating this new spray-on antibiotic.”
Burn wound specialists will oversee the delivery of RECCE 327 in a spray-on formulation, specifically developed for the study. The product has been produced at Recce’s manufacturing facility, to the same standards as the RECCE 327 used in the company’s Phase 1 intravenous clinical trial. The company anticipates that the two studies will run in parallel, demonstrating the broad administration capabilities of RECCE 327.
Recce Pharmaceuticals has also reported that RECCE 327 has demonstrated encouraging virucidal activity against the SARS-CoV-2 virus, with a positive safety profile. This finding is based on independent tests conducted by the Commonwealth Scientific and Industrial Research Organisation, and the Peter Doherty Institute for Infection and Immunity, as part of its SARS-CoV-2 anti-viral screening program.
“We continue to be encouraged by the results from the antiviral SARS-CoV-2 screening program as it reinforces our belief in the potential of RECCE 327 against COVID-19, including emerging variant strains. We would like to thank the Doherty Institute for performing the experiments, and look forward to coming studies,” noted Prendergast in a press release.
RECCE 327 showed a reduction in SARS-CoV-2 viral genome numbers at 4,000 parts per million (ppm), and virus was no longer detectable by viral titration; RT-PCR detected the three-log drop in viral genome copies (99.9% reduction). Antiviral testing was conducted in triplicate with a very small variance bar above the 4,000 ppm data point. Minimal toxicity was observed at 4,000 ppm of R327, and there was no cytotoxicity at or below 1,333 ppm.
Further testing will be required at higher dose levels to establish the IC50 and cytotoxicity, before RECCE 327 is confirmed as being active against the SARS-CoV-2 virus. The results will help Recce to decide whether to pursue RECCE 327 as an SARS-CoV-2 inhibitor candidate.