Recce Pharmaceuticals Ltd. 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). 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. 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%.