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Recce Pharmaceuticals Announces Expansion of Phase I/II Trial of RECCE® 327 for the Treatment of Diabetic Foot Infections
SYDNEY, Australia, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q), (the Company), the Company developing a new class of synthetic anti-infectives, today announced the expansion of its ongoing Phase I/II trial evaluating the safety and efficacy of its lead candidate, RECCE® 327 (R327), in patients with diabetic foot infections (DFI) based on the interim data analysis and the study achieving its primary endpoints. The objective of this trial is to evaluate R327’s potential as a topical broad-spectrum anti-infective treatment. An Independent Safety Committee of Liverpool Hospital NSW has completed a review of the clinical data, confirming the study is achieving its primary endpoints of safety and efficacy through daily or second daily application of R327, resolving/curing bacterial infections in diabetic foot ulcers (DFU). All parties involved have agreed to broaden the patient description and stage of DFU infection to award greater patient access to the potential benefits of joining the Liverpool Hospital NSW Clinical trial. In the coming months, additional study sites both locally and overseas will become active and include the broader patient population in the study. Of the estimated 537 million people worldwide who have diabetes, 19–34% will develop a DFU in their lifetime. Approximately 20% of people who develop a DFU will require lower-extremity amputation, either minor (below the ankle), major (above the ankle), or both.1 “I am greatly encouraged by the speed at which my patient's diabetic foot ulcer infections have responded to R327 when applied topically,” said Professor Hugh Dickson, Director of Ambulatory Care at Liverpool Hospital and Principal Investigator of the Phase I/II trial. “A non-invasive method to treat the burdensome challenges of diabetic foo ulcer infections gives hope to better patient outcomes and avoid limb amputation, as is so commonly the case with these complicated patients. We thank the independent committee's recognition of the many world-firsts taking place in this DFI clinical trial and welcome expanded access to patients both here at Liverpool Hospital and medical settings beyond.” James Graham, Chief Executive Officer of Recce Pharmaceuticals, added, “We are pleased with the decision of the independent committee. We look forward to seeing the potential of R327 utilized as a treatment option in patients suffering from DFIs and offering a chance at a better quality of life without the devastating consequences of amputation.” About Recce Pharmaceuticals Ltd Recce’s anti-infective pipeline includes three patented, broad-spectrum, synthetic polymer anti-infectives: RECCE® 327 as an intravenous and topical therapy that is being developed for the treatment of serious and potentially life-threatening infections due to Gram-positive and Gram-negative bacteria including their superbug forms; RECCE® 435 as an orally administered therapy for bacterial infections; and RECCE® 529 for viral infections. Through their multi-layered mechanisms of action, Recce’s anti-infectives have the potential to overcome the hypercellular mutation of bacteria and viruses – the challenge of all existing antibiotics to date. 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. Further to this designation, RECCE® 327 has been included on The Pew Charitable Trusts Global New Antibiotics in Development Pipeline as the world’s only synthetic polymer and sepsis drug candidate in development. RECCE® 327 is not yet market approved for use in humans with further clinical testing required to fully evaluate safety and efficacy. Recce wholly owns its automated manufacturing, which is supporting present clinical trials. Recce’s anti-infective pipeline seeks to exploit the unique capabilities of its technologies targeting synergistic, unmet medical needs. Corporate Contact Media & Investor Relations (AU) Media (USA) Investor Relations (USA & EU) 1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9797649/ 
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