Phase I/II trial assessing the safety and efficacy of RECCE® 327 (R327), a broad-spectrum anti-infective as a topical treatment, met all primary endpointsR327 was well-tolerated in all patients, resolving mild skin and soft tissue diabetic foot infections (DFI), including multidrug-resistant Gram-positive and Gram-negative pathogensData supports imminent domestic and international site expansion SYDNEY, Australia, Jan. 23, 2024 (GLOBE NEWSWIRE) — Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q), (the Company), the Company developing a new class of synthetic anti-infectives, today announced positive results from a Phase I/II trial assessing the safety and efficacy of its lead synthetic anti-infective candidate, RECCE® 327 (R327), in patients with diabetic foot infections (DFI). “We are pleased that the Phase I/II clinical trial has met all primary endpoints and produced efficacy data to support R327 as a topical agent,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals. “We look forward to expanding the study by accessing a global patient population and further enhancing our portfolio of human efficacy data.” The Phase I/II trial is an interventional study assessing the safety and efficacy of R327 as a topical broad-spectrum anti-infective treatment for patients with mild skin and soft tissue DFIs. Patients were treated either daily or every second day for 14 days. The study achieved its primary endpoint of resolving/curing bacterial infections in DFIs. Following this success, Recce will look to expand clinical sites domestically and internationally to access a greater patient population. Summary of Treated Patients Application FrequencyAge (yrs)/ Sex Wound Location Clinical Response Patient 1Daily32 / MLeft forefoot lateral aspectEscalated therapy*Patient 2Second Daily55 / MRight hallux plantar aspectInfection resolved/cured Patient 3Second Daily51 / MLeft forefoot plantar aspectInfection resolved/curedPatient 4Daily70 / MLeft forefoot plantar aspectInfection resolved/curedPatient 5Daily64 / MRight hallux dorsal aspectInfection resolved/cured Patient 1 (Daily) – (Methicillin-Resistant Staphylococcus aureus infection) * A 32-year-old male with a four-year history of type 2 diabetes mellitus, coupled with various cardiovascular risk factors such as hypertension, obesity, and dyslipidaemia, abnormally elevated cholesterol in the blood. The 235kg patient was recruited with a significant neuropathic wound, an infection that affects one or more nerves, on the left side of his left foot. The patient was on systemic therapy and was required to stop treatment to meet the trial protocol of R327, requiring solely topical application. On day 15 (midpoint), post-R327 treatment, the initial redness of the wound and swelling of the foot had minimized and reduced in size. Due to patient comorbidities and the complexity of the wound, the patient was returned to systemic therapy, resulting in disqualification from the trial. On Day 28, the infection was resolved, and all therapy ceased. Patient 2 (Second Daily) – Infection Resolved/Cured (Staphylococcus aureus, mixed skin flora, and Coliforms)A 55-year-old male with a 23-year history of type 2 diabetes mellitus and an active neuropathic DFI wound on his right big toe, with recurrent infections unresponsive to several antibiotics. After three doses of R327 treatment (midpoint – day 7), the infection was significantly reduced, with the wound drying and rapidly improving. By the endpoint (day 14) of the patient’s treatment, the infection was resolved/cured, and no recurrence of infection was identified. R327 was well-tolerated and effective throughout the patient’s treatment therapy. Patient 3 (Second Daily) – Infection Resolved/Cured (Staphylococcus aureus, mixed skin flora, and mixed coliforms)A 52-year-old male with a 16-year history of type 2 diabetes mellitus and a DFI wound on the left side of his left foot. After three doses of R327 (midpoint – day 7), the infection was significantly reduced and shown to be rapidly clearing. At the endpoint (day 14) of the R327 treatment, the infection had been resolved. No follow-ups were required, as R327 was well-tolerated and effective throughout the patient’s treatment. Patient 4 (Daily) – Infection Resolved/Cured in Half the Treatment Time (mixed skin flora)A 70-year-old male with type 2 diabetes mellitus and a DFI wound on the left side of his left foot. The patient was observed at the midpoint (day 7) of the R327 treatment, with the infection resolved/cured in half the time. No follow-ups were required, as R327 was well-tolerated and effective throughout the patient’s treatment. Patient 5 (Daily) – Infection Resolved/Cured (mixed skin flora and Coliforms)A 64-year-old male with type 2 diabetes mellitus and a DFI wound on his right foot. At the midpoint (day 7) of R327 treatment, the infection was significantly reduced and shown to be improving. At the endpoint (day 14) of the R327 treatment, the infection had been resolved. R327 was well-tolerated and effective throughout the patient’s treatment. Diabetes is the leading cause of non-traumatic lower extremity amputations in the United States (U.S.), with 14-24% of patients with diabetes (who develop a foot ulcer) requiring amputation. Furthermore, foot ulceration leads to 85% of diabetes-related amputations. Treating diabetic foot diseases in the U.S. costs $9-13 billion annually.1 A worldwide meta-analysis reported diverse bacteria from DFI, and the organism most commonly identified was Staphylococcus aureus, with a pooled prevalence estimate of 18.0%.2 About Recce Pharmaceuticals Ltd Recce 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 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 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 Zhang P. et al. – “Global epidemiology of diabetic foot ulceration: A systematic review and meta-analysis” (dagger) – Ann. Med. 2017;49:106–116. 2 https://www.nature.com/articles/s41598-023-41882-z