RECCE-327

Human Research Ethics Committee (HREC) approval received to allow up to 20 additional patients access to RECCE® 327 Topical Gel (R327G) treatment under existing open-label study protocolProgram enables access to R327G for diabetic foot infections (DFI), following recent positive Phase II results in acute bacterial skin and skin-structure infections (ABSSSI), including diabetic foot ulcers (DFU)Access focused on patients with DFU infections given the unmet medical need, as ~40% experience ulcer recurrence within a year of healingThe study will start now, running in parallel to Registrational Phase 3 in Indonesia for DFI and planned Registrational Phase 3 for ABSSSI in Australia, on track for H2 2025 SYDNEY, April 23, 2025 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q), (Recce or the Company), a leading developer of a new class of synthetic anti-infectives, today announced it received Human Research Ethics Committee (HREC) approval to build upon its open-label Phase II trial of RECCE® 327 Topical Gel (R327G) for the treatment of diabetic foot infections (DFI), enabling the enrollment of up to 20 additional patients. “This approval allows us to build upon the strong clinical results of R327G and continue demonstrating its potential as a differentiated treatment for DFIs,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals. “We are pleased to continue to provide access to R327G to diabetic patients in need, and to further build out our data portfolio alongside our Phase 3 programs in both Australia and Indonesia.” The use of R327G under this protocol follows strong interest by investigators encouraged by the highly promising results of the recently released Phase II data, where R327G demonstrated, after 7 days of treatment, 86% of patients had a successful clinical response (the primary endpoint also used by the U.S. FDA). At 14 days of treatment, >90% of patients achieved a primary efficacy endpoint. The investigators of the trial have expressed confidence in R327G as a safe and well-tolerated therapeutic, particularly in difficult-to-treat infections such as DFIs, where standard treatments often fall short. Using a gel avoids systemic (oral & IV) antibiotics with their associated adverse effects. This study offers an opportunity to further strengthen the clinical profile of R327G while addressing the urgent needs of patients currently lacking effective treatment options. The study will start now and run in parallel with Recce’s Indonesian Phase 3 trial, which remains on track to commence shortly. This program does not impact the initiation timeline of the Registrational Phase 3 DFI study in Indonesia or the planned Registrational Phase 3 ABSSSI study in Australia. The study is designed to run in parallel and is expected to generate additional data to support future regulatory submissions. The study will be conducted by Barwon Health, further supporting the Company’s clinical momentum in Australia. Alan W. Dunton, MD, Chief Medical Advisor and Non-Executive Director of Recce Pharmaceuticals, added, “It is important to provide additional therapeutic options to diabetic patients with infections. Recce’s compound has an optimal profile as a localised therapeutic for patients, in contrast to treatment with IV and oral antibiotics, which are often not effective and are accompanied by unwanted side effects such as diarrhea and gastrointestinal distress.” The recurrence rate of DFI within 1 year after healing is 40%, the recurrence rate is 60% within 3 years, and 65% within 5 years.1 The risk of a person with diabetes developing a foot infection has been estimated to be between 34%2 and 50%. These infections can lead to sepsis, gangrene, amputation, and death.3 About Recce Pharmaceuticals LtdRecce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) is developing a New Class of Synthetic Anti-Infectives designed to address the urgent global health problems of antibiotic-resistant superbugs and emerging viral pathogens. Recce’s anti-infective pipeline includes three patented, broad-spectrum, synthetic polymer anti-infectives: RECCE® 327 (R327) 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 (R435) as an orally administered therapy for bacterial infections; and RECCE® 529 (R529) for viral infections. Through their multi-layered mechanisms of action, Recce’s anti-infectives have the potential to overcome the processes utilised by bacteria and viruses to overcome resistance – a current challenge facing existing antibiotics. The World Health Organization (WHO) added R327, R435, and R529 to its list of antibacterial products in clinical development for priority pathogens, recognising Recce’s efforts to combat antimicrobial resistance. The FDA granted R327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act, providing Fast Track Designation and 10 years of market exclusivity post approval. R327 is also included on The Pew Charitable Trusts’ Global New Antibiotics in Development Pipeline as the sole synthetic polymer and sepsis drug candidate in development. Recce wholly owns its automated manufacturing, supporting current clinical trials. Recce’s anti-infective pipeline aims to address synergistic, unmet medical needs by leveraging its unique technologies. Corporate ContactJames GrahamRecce Pharmaceuticals Ltd+61 (02) 9256 2571James.graham@recce.com.au Media & Investor Relations (AU)Andrew GeddesCityPR+61 (02) 9267 4511ageddes@citypublicrelations.com.au Media (USA)Michael FitzhughLifeSci Communicationsmfitzhugh@lifescicomms.com Investor Relations (USA & EU)Guillame van RenterghemLifeSci Advisorsgvanrenterghem@lifesciadvisors.com 1 https://pmc.ncbi.nlm.nih.gov/articles/PMC10088840/#iwj14017-bib-0004 2 https://www.ncbi.nlm.nih.gov/books/NBK409609/ 3 https://www.uptodate.com/contents/evaluation-of-the-diabetic-foot