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RECCE® 327 Topical
RECCE® 327 (R327) was developed beginning with the end in mind, being entirely synthesised to capture and enhance unique mechanisms of action, able to overcome deadly bacterial infections, including the full suite of ESKAPE pathogens, even in their multi-drug resistant forms.
Overview
Diabetic foot infections (DFI) are the most common cause of nontraumatic foot amputations in those with diabetes, occurring in about 15% of patients. These infections are generally found at the bottom of the foot within the soft tissue. 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.
Worldwide
Cases
9-26 million
diabetic foot ulcer cases annually.
USA
82,000
amputations are performed annually on patients with diabetes
Ongoing Clinical Trials
- The company has received approval from the Indonesian Drug and Food Regulatory Authority, Badan POM, to initiate its Registrational Phase 3 clinical trial assessing RECCE® 327 as a topical gel (R327G) for the treatment of diabetic foot infections (DFIs). This significant milestone follows the recent human ethics committee approval to commence patient dosing, underscoring Recce’s clinical research's alignment with regulatory and ethical standards within Indonesia.
- The Company completed a Phase I/II proof-of-concept study, evaluating the safety and efficacy of topical R327 in patients with mild skin and soft tissue diabetes foot infections (DFIs). Patients were treated either daily or every second day, for 14 days. The study achieved its primary endpoints of resolving/curing bacterial infections in DFIs. R327 was well-tolerated in all patients.
- Upon receiving positive results from the Phase I/II study, Recce received Human Research Ethics Committee approval for a Phase II clinical trial of R327 topical gel for testing against Acute Bacterial Skin and Skin Structure Infections (ABSSSI), with patient dosing now at its final stages.
- Recce enrolled in the Therapeutic Goods Administration (TGA) Special Access Scheme (SAS) Category A for the utilisation of RECCE® 327 Gel (R327G) by a qualified medical practitioner across patients suffering antibiotic-resistant Gram-positive and Gram-negative bacterial infections, where all patients have been either cured or seen a significant improvement.
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.
R327, as a topical therapy, is being studied in a broad range of bacterial wounds, burns, and skin infections.
In a preclinical study in rats, R327 showed significant antibacterial activity against Methicillin-resistant Staphylococcus aureus (MRSA), difficult-to-treat bacteria that causes staph infections. The data demonstrated a reduced bacterial load and a higher percentage of wound closure with increasing doses of R327 compared to Soframycin.
In an ongoing Phase I/II study in patients with infected burn wounds, R327, as a topical spray, has demonstrated promising data thus far with the return of healthy skin growth, reduced swelling and infection, and indications of tissue penetration to the underlying infection.