Recce Pharmaceuticals Announces Agreement with Fiona Stanley Hospital for a Phase 1/2 Clinical Trial Evaluating Topical Spray-On Antibiotic RECCE® 327 on Chronic Burn Wounds
- Phase I/II trial agreement with Fiona Stanley Hospital (Burns Unit) in Perth Western Australia
- Study led by world leading burn treatment specialists
- Study will assess safety and efficacy of RECCE® 327 against a broad range of infectious disease on chronic burn wounds in up to 30 patients
- RECCE® 327 formulated as new spray-on antibiotic for chronic burn wounds
- First patients to be dosed in present quarter
SYDNEY, Australia, Feb. 16, 2021 (GLOBE NEWSWIRE) -- Recce Pharma Ltd (ASX:RCE), the Company developing new classes of synthetic anti-infectives, today announced it has formalized an agreement with Fiona Stanley Hospital for a Phase 1/2 clinical trial to assess the potential of RECCE® 327’s new spray-on, 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 Recce Pharmaceuticals Non-Executive Chairman Dr. John Prendergast. “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 trial investigators are 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 State Adult Burns Unit at Fiona Stanley Hospital, internationally renowned burns surgeon, known for pioneering the development of ‘spray-on skin.’
Dr. Raby said, “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. We look forward to evaluating this new spray-on antibiotic.”
The Phase 1/2 topical study will enroll up to 30 patients and be conducted at Fiona Stanley Hospital Burns Unit in Perth Western Australia. The study will 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 expanding 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 present quarter.
Burn wound specialists will oversee delivery of RECCE® 327 in a spray-on formulation, specifically developed for the study. The product has been produced at the Company’s manufacturing facility to the same human clinical study standards as the previously announced Phase 1 intravenous clinical trial. It is anticipated the two studies will run in parallel, demonstrating the broad administration capabilities of RECCE® 327.
About Recce Pharmaceuticals Ltd
Recce Pharmaceuticals Ltd (ASX: RCE) is pioneering the development and commercialization of New Classes of Synthetic Anti-Infectives designed to address the urgent global health problems of antibiotic resistant superbugs and emerging viral pathogens.
Recce antibiotics are unique – their potency does not diminish even with repeated use, a common failure associated with existing antibiotics and their propensity to rapidly succumb to resistant superbugs.
Patented lead candidate RECCE® 327, wholly owned and manufactured in Australia, has been developed for the treatment of blood infections and sepsis derived from E. coli and S. aureus bacteria – including their superbug forms.
The FDA has awarded RECCE® 327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act – labelling it for Fast Track Designation, plus 10 years of market exclusivity post approval.
Recce wholly owns its automated manufacturing, ready to support first-in-human clinical trials. Recce’s anti-infective pipeline seeks to exploit the unique capabilities of RECCE® technologies targeting synergistic, unmet medical needs.
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