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Sydney-based Recce Pharmaceutical Ltd (ASX:RCE) has reached a landmark stage in its bid to commercialise a topical gel that would treat diabetic foot infections (DFIs), gaining approval for a Phase 3 trial in Indonesia to assess the gel in question, RECCE 327 (or R327G).
Two achievements have made this possible: The first being Recce’s gaining of approval from the Indonesian Drug and Food Regulatory Authority – Badan POM – for the Registrational Phase 3 clinical trial.
Alongside this, Recce’s human ethics committee has approved commencement of patient dosing, and the alignment of both means the trial is on-track to begin this quarter.
Indonesia and diabetes: A growing health concern
While extending its global therapeutic footprint is an important priority for any pharmaceutical company, one might ask why Recce has decided to launch a trial in Indonesia in particular.
In fact, the upward trend of diabetes in the country has been acknowledged as a serious health issue since the 1980s, and today it has one of the world’s largest patient populations for the condition.
Data from the International Diabetes Federation (IDF) has shown that, in 2021, 10.6% (or around 19 and a half million people) were affected by diabetes mellitus – the group of conditions associated with high blood glucose – in Indonesia. By 2030, this was predicted to grow to 11.3% of the population (accounting for more than 23 million people).
Crucially, the same data set indicated that in 2021, 73.7% of people with diabetes were undiagnosed.
DFIs: A critical health challenge
People living with diabetes are faced with a number of associated health problems, including foot infections, urinary tract infections, and surgical site infections.
The former in particular can have serious consequences when left untreated: Diabetic foot infections (DFIs) remain the most common cause of nontraumatic foot amputations among people living with diabetes – 15% of patients experience this.
The infections are mostly found at the bottom of the foot, within its soft tissue, and they are often caused by more than one pathogen – with between 50% and 80% of these wounds being polymicrobial. The pathogens often responsible for DFI infections include S. aureus, Enterococcus, P. aeruginosa, and E. coli.
Taken together, the seriousness of diabetes growth within Indonesia – plus the large percentage of people who experience foot amputations as a result of DFIs – makes Recce’s Registrational Phase 3 trial for its topical gel to treat the latter a timely study.
In fact, it is one of the largest DFI studies in the world, and the first of its kind within Indonesia.
This was acknowledged by the chairman of Indonesia’s Drug and Food Regulatory Authority – also known as Badan POM – who said:
“The approval of Recce Pharmaceuticals’ Phase 3 clinical trial is an important step in advancing treatment options for DFIs in Indonesia. Badan POM is committed to supporting the timely development of innovative therapies to address this critical health challenge. This collaboration aligns with Indonesia’s mission to advance healthcare solutions for our population, and we look forward to seeing the impact of this trial for patients in need of new, effective anti-infective treatments.”
Moving towards commercialisation
While contributing to Indonesia’s healthcare landscape through the introduction of a novel treatment for infectious diseases is a key goal of this trial, it also aligns with Recce’s goal of pushing its topic gel through to commercialisation.
Recce’s chief executive officer James Graham said being able to move forward with the Phase 3 trial was an important milestone for the company.
“The approval from the Indonesian National Drug and Food Authority to initiate this pivotal Phase 3 trial in Recce’s clinical development is a significant achievement, bringing Recce closer to commercialisation and profitability,” he said.
“We also acknowledge the support of Investment NSW, Austrade, and the Australian Embassy team in Jakarta who played an important role in helping with the approval process.
“We look forward to evaluating R327G in our first Phase 3 trial.”
As an anti-infective, the company’s R327 candidate is being assessed in various forms to check its efficacy in treating various bacterial wounds, burns, and skin infections.
During a preclinical study on rats, it revealed notable antibacterial activity against Methicillin-resistant Staphylococcus aureus (MRSA), difficult-to-treat bacteria that causes staph infections.
In the form of a topical spray, R327 is also the subject of an ongoing Phase I/II study in patients with infected burn wounds, and has demonstrated impressive data so far, including the return of healthy skin growth, reduced swelling and infection, and signs of tissue penetration to the underlying infection.
Building on the success of this trial, Recce commenced a Phase I/II proof-of-concept study at the South West Sydney Limb Preservation and Wound Research Unit to evaluate the safety and efficacy of R327 in patients with mild skin and soft tissue diabetic foot infections (DFIs).
Thus, Recce’s new trial initiative in Indonesia aims to build on a solid history of assessment for this treatment.
Recce has been trading at 47 cents.
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