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RECCE® 327 Topical
RECCE® 327 Topical Gel (R327G) is in registrational Phase 3 trials for diabetic foot infections in Indonesia and Australia. It is a wholly synthetic anti-infective with a unique mechanism of action, designed to rapidly kill Gram-positive and Gram-negative bacteria, including the full suite of ESKAPE pathogens.
Overview
Diabetic foot infections (DFIs) are the most common cause of non-traumatic lower-limb amputation in people with diabetes. Approximately one in three adults with diabetes will develop a diabetic foot ulcer in their lifetime. These infections typically begin in the soft tissue of an ulcer on the sole of the foot. Several pathogens, such as S. aureus, Enterococcus, P. aeruginosa, and E. coli, typically cause DFI infections, with 50-80% of wounds being polymicrobial.
The total medical cost for treating diabetic foot diseases in the U.S. is $9-13 billion per year. Studies have shown that between 14-24% of patients with diabetes who develop a foot ulcer will require an amputation, and foot ulceration precedes 85% of diabetes-related amputations. Diabetes is responsible for 60% of all amputations in Australia, one of the worst diabetes-related lower-limb amputation rates in the developed world.
Worldwide
Cases
9-26 million
diabetic foot ulcer cases annually
Australia
60%
of all amputations in Australia are caused by diabetes
Indonesia
46.9%
of hospitalised DFI patients undergo amputation
Strategic Opportunity in South-East Asia
- Patient dosing is underway at clinical sites across Indonesia. The double-blind, placebo-controlled trial will enrol up to 310 patients, with an interim analysis after 155. The primary endpoint is clinical response on the Lipsky Scale.
- Opportunity to access 10 ASEAN member states – 680 million inhabitants, including 280 million in Indonesia.
- Significant bilateral initiative supported by Australian and Indonesian Governments.
- Additional indications expected to follow, including tuberculosis, post-operative infections and burn wounds.
- Significant medical need: In-hospital treatment costs averaging IDR 64.95 million (~US$4,100) per patient and significantly higher costs for amputees, highlighting the substantial clinical and economic burden of DFI on the national health system.
Ongoing Clinical Trials
- Completed – Phase I/II DFI and Phase II ABSSSI: In a Phase I/II study in patients with mild diabetic foot infections, R327 topical gel achieved its primary endpoints and was well tolerated in all patients. A follow-on Phase II trial in acute bacterial skin and skin structure infections (ABSSSI) met all primary and secondary endpoints. After 14 days, 93% of patients met the primary efficacy endpoint, with no serious adverse events reported.
- Registrational Phase 3 – Indonesia: Patient dosing is underway at clinical sites across Indonesia in a double-blind, placebo-controlled trial of R327 topical gel in patients with mild DFI. The trial will enrol up to 310 patients, with an interim analysis after 155.
- Registrational Phase 3 – Australia: The Australian Phase 3 trial is a randomised, active-controlled study comparing R327 topical gel with one of four physician-selected antibiotics. A protocol amendment has expanded eligibility from mild to mild and moderate DFI, which together make up around 80% of DFI presentations. The trial will enrol 208 patients, with an interim analysis after 104, to support approval applications to the TGA and US FDA.
About RECCE® 327 Topical
RECCE® 327 (R327) is a synthetic anti-infective developed for the treatment of serious and potentially life-threatening infections due to Gram-positive and Gram-negative bacteria, including the full suite of ESKAPE pathogens, even in their superbug forms. R327’s novel mechanism of action (MoA) is designed to safely enter the body, identify and treat an infection, and exit – with the potential to overcome antimicrobial resistance.
Stage 1 of a Phase I/II study in patients with infected burn wounds is complete. R327, as a topical spray, has demonstrated promising data with the return of healthy skin growth, reduced swelling and infection, and indications of tissue penetration to the underlying infection.