Recce Pharmaceuticals Ltd has received positive findings from a Phase II clinical trial evaluating RECCE® 327 Topical Gel (R327G) for Acute Bacterial Skin and Skin Structure Infections (ABSSSI), including Diabetic Foot Infections (DFI).
The study surpassed its objectives, achieving a 93% primary efficacy endpoint over a 14-day treatment period.
These results validate Recce’s approach for its upcoming Approved Registrational Phase III DFI study in Indonesia, where efficacy can be assessed earlier through interim analysis, with a readout expected in 2025.
Additionally, the company will advance to a Registrational Phase III trial for ABSSSI/DFI in Australia.
The data reinforces the strong efficacy of Recce’s synthetic anti-infective technology, now in late-stage clinical development.
Commercialisation pathway
Supported by an innovative regulatory strategy, the company aims for an accelerated commercialisation pathway by 2026.
"These impressive results underscore the potential of our topical gel to meet critical unmet medical needs in infection treatment. As we advance towards registrational Phase 3 trials in Indonesia and Australia we are encouraged by the rapid efficacy and strong safety outcomes demonstrated in this study,” Recce Pharmaceuticals CEO James Graham said.
“The global ABSSSI treatment market is a substantial commercial opportunity, valued at US$7.3 billion (A$11.4 billion) in 2018 and expected to reach US$26 billion by 2032, at a CAGR of 9.5% between 2019 and 2032.
"Going forward with our clinical programs, this gives us great confidence in addressing ABSSSI."
93% primary efficacy endpoint
Recce’s Phase II clinical trial has confirmed that R327G achieved a 93% primary efficacy endpoint over 14 days, successfully meeting all study endpoints.
Interim data showed that after seven days of treatment, 86% of patients (25 out of 29) demonstrated a successful clinical response. By day 14, the response rate increased to 93% (27 out of 29).
The trial also confirmed R327G's safety and tolerability with no serious adverse events reported.
A total of 30 patients were enrolled in the study with 29 included in the final analysis. One patient was withdrawn due to pre-existing wound site pain, which was deemed unrelated to the treatment.
Phase 2 trial outcomes
The Phase 2 open-label study successfully met all primary and secondary endpoints, assessing the safety, tolerability, efficacy and plasma pharmacokinetics of R327G when applied directly to infected areas. The trial included male and female patients aged 18 and above, with no upper age limit.
Data from the study align with the US Food and Drug Administration’s (FDA) focus on novel broad-spectrum antibiotics to combat antimicrobial resistance (AMR).
Acute bacterial skin and skin structure infections (ABSSSIs) such as DFI, necrotising fasciitis and post-operative wound infections remain a significant healthcare challenge.
Due to ethical considerations, no ABSSSI studies use placebo controls, as withholding treatment from infected patients is not permissible.
The trial used FDA-accepted diagnostic tools, including the Lipsky Clinical Resolution of Infection Scale and the Bates-Jensen Wound Assessment Tool, to evaluate wound severity and healing.
Patients were classified as either "cured," indicating full clinical response, or "improved," demonstrating partial wound healing with potential for full recovery beyond the 14-day study period.
These findings provide a strong foundation for the Phase 3 trial, reinforcing the potential of R327G as an effective treatment for DFI and related infections.
Confident in potential
“Our robust dataset, from pre-clinical, clinical and TGA special access scheme use cases, gives us confidence in the potential of our topical gel," Recce Pharmaceuticals director & chief medical advisor Dr Alan Dunton said.
"These results reflect the broad-spectrum nature and rapid onset of effect of R327G, which positions us well for the upcoming Phase 3 trials in Indonesia and Australia.
“Importantly, Recce has also demonstrated that its R327 anti-infective compounds are effective against diverse species of bacteria, including in-vitro against over 500 clinical isolates, many previously considered as drug-resistant."
Phase 3 trial for diabetic foot infections set for early completion following strong Phase 2 results
The encouraging results have led experts to determine that the ongoing Phase 3 registrational trial for diabetic foot infections (DFI) could reach a statistically significant positive endpoint after enrolling approximately 100 patients, instead of the originally planned 300.
The Indonesian Drug and Food Regulatory Authority (Badan POM) has approved the study protocol, which includes an interim analysis, with data expected to be completed by the end of the year.