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Highlights:
- 93% Efficacy Rate: Recce Pharmaceuticals (ASX:RCE) reported that R327G achieved a 93% primary efficacy endpoint in its Phase II trial for bacterial skin infections.
- Phase III Progress: The company is moving forward with Phase III registrational trials in Indonesia and Australia, with data readout expected in 2025.
- Market Opportunity: The global market for ABSSSI treatments was valued at US$7.3 billion (A$11.4 billion) in 2018 and is projected to reach US$26 billion by 2032.
Recce Pharmaceuticals Ltd (ASX:RCE) has reported promising 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 demonstrated a 93% primary efficacy endpoint over a 14-day treatment period, positioning the therapy as a strong candidate for further clinical development.
The successful completion of the Phase II trial validates the company’s approach and supports the advancement of R327G into a registrational Phase III DFI trial in Indonesia, where interim analysis is expected to provide early efficacy data in 2025. Recce Pharmaceuticals is also preparing for an additional Phase III trial for ABSSSI/DFI in Australia.
Phase II Study Outcomes
The Phase II clinical trial confirmed that R327G achieved a 93% primary efficacy endpoint, surpassing expectations. Interim data revealed 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 study further confirmed the safety and tolerability of R327G, with no serious adverse events reported. A total of 30 patients were enrolled, with 29 included in the final analysis. One patient was withdrawn due to pre-existing wound site pain, which was determined to be unrelated to the treatment.
Regulatory and Commercial Strategy
Recce Pharmaceuticals is implementing an innovative regulatory strategy to accelerate the commercialisation of R327G, aiming for market entry by 2026. The global market for ABSSSI treatments is projected to grow at a compound annual growth rate (CAGR) of 9.5%, reaching US$26 billion by 2032.
The Phase III registrational trial in Indonesia has been approved by the Indonesian Drug and Food Regulatory Authority (Badan POM), with an interim analysis scheduled before the completion of the study. The Phase III trial for diabetic foot infections (DFI) is expected to achieve a statistically significant endpoint after enrolling approximately 100 patients, a reduction from the initially planned 300, expediting its completion.
FDA-Recognised Diagnostic Standards and Study Design
The Phase II open-label study assessed the safety, tolerability, efficacy, and plasma pharmacokinetics of R327G in treating bacterial skin infections. The study adhered to FDA-accepted diagnostic methodologies, including the Lipsky Clinical Resolution of Infection Scale and the Bates-Jensen Wound Assessment Tool, to measure wound severity and healing progression.
Due to ethical considerations, ABSSSI studies do not use placebo controls, as withholding treatment from infected patients is not permissible. 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.
Clinical and Market Potential
Recce Pharmaceuticals' synthetic anti-infective technology, R327G, has demonstrated a broad-spectrum capability against bacterial infections, including strains resistant to conventional antibiotics. The drug has shown effectiveness in vitro against over 500 clinical isolates, positioning it as a potential breakthrough in combating antimicrobial resistance (AMR).
The company’s rapid progress through clinical trials highlights the strong demand for effective ABSSSI treatments. The substantial global market for ABSSSI therapies underscores the commercial potential of R327G, aligning with Recce Pharmaceuticals’ strategy to address unmet medical needs in infection treatment.
Pathway to Phase III and Beyond
With Phase II results confirming the efficacy and safety of R327G, Recce Pharmaceuticals is focused on expediting Phase III trials. The company aims to provide further clinical validation through its registrational studies in Indonesia and Australia, with interim data expected by the end of 2025.
Recce Pharmaceuticals continues to advance its proprietary anti-infective platform, reinforcing its position as a leader in the development of novel antibiotics for hard-to-treat bacterial infections. The upcoming Phase III trials mark a significant step towards commercialisation, with the potential to bring R327G to market in the near future.
