Leading developer of synthetic anti-infectives Recce Pharmaceuticals Ltd has been given the go-ahead to build on its Phase 2 clinical trial for the treatment of diabetic foot infections (DFI) following Human Research Ethics Approval (HREC).
The study offers an opportunity to further strengthen the clinical profile of R327G while addressing the urgent needs of patients currently lacking effective treatment options.
Considerable unmet need
DFI is a considerable unmet medical need – the risk of a person with diabetes developing a foot infection has been estimated to be between 34% and 50%.
What’s more, these infections can lead to sepsis, gangrene, amputation and death. The risk of recurrence is high. The return rate of DFI within one year after healing is 40%, while the recurrence rate within three years is 60%, and 65% within five years.
“It is important to provide additional therapeutic options to diabetic patients with infections,” chief medical advisor and non-executive director Dr Alan W Dunton said.
“Recce’s compound has an optimal profile as a localised therapeutic for patients, in contrast to treatment with IV and oral antibiotics which, are often not effective and are accompanied with unwanted side effects such as diarrhea and gastrointestinal distress.”
About the trial
The company has approval to enrol up to 20 additional patients with DFI, to provide access to R327G in this open-label study.
This follows recently released positive Phase 2 clinical trial data on R327G for acute bacterial skin and skin-structure infections (ABSSSI), including DFI.
The use of R327G under this protocol follows strong interest by investigators encouraged by the highly promising results of the recently released Phase 2 data.
The data revealed that 86% of patients treated with R327G had a successful clinical response after seven days of treatment – the primary endpoint also used by FDA – and at 14-days of treatment, more than 90% of patients had achieved a primary efficacy endpoint.
DFI patients were prioritised given the unmet medical need, with around 40% ulcer recurrence in diabetics within first year of an ulcer healing.
The Phase 2 trial starts imminently and will be conducted by Barwon Health, which propels the company’s clinical momentum in Australia.
In parallel, the company is progressing a Registrational Phase 3 trial in Indonesia – a key gateway jurisdiction to ASEAN markets – for DFI, while a planned Registrational Phase 3 for ABSSSI in Australia is on track for the second half of this year.
Safe topical gel
R327G as a safe and well tolerated therapeutic that has demonstrated efficacy, particularly in difficult-to-treat infections such as DFIs, where standard treatments can fall short.
The gel formulation circumvents the use of systemic (oral and IV) antibiotics with their associated adverse effects.
CEO James Graham said: "This approval allows us to build upon the strong clinical results of R327G and continue demonstrating its potential as a differentiated treatment for DFIs.
“We are pleased to continue to provide access to R327G to diabetic patients in need, and to further build out our data portfolio alongside our Phase 3 programs in both Australia and Indonesia.”