Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has received another key approval in Indonesia for a registrational Phase 3 clinical trial assessing RECCE® 327 as a topical gel (R327G) for the treatment of diabetic foot infections (DFIs).
Approval from the Indonesian Drug and Food Regulatory Authority, Badan POM, sees Recce on track to begin the registrational Phase 3 clinical trial this month and brings forward commercial opportunities for the company in the lucrative ASEAN region.
This expedited regulatory milestone follows the recent human ethics committee approval to begin patient dosing, underscoring Recce’s clinical research's alignment with regulatory and ethical standards within Indonesia.
Positive move in Indonesia
The registrational Phase 3 clinical trial will not only be significant for Recce’s growth but will also contribute positively to Indonesia's healthcare landscape by introducing potential novel treatments for infectious diseases.
Significantly, this aligns with the company’s commitment to addressing critical health challenges on an international scale.
With more than 19.5 million adults living with diabetes in Indonesia, the need for innovative therapies to address diabetes-related infections, such as foot infections, urinary tract infections and surgical site infections, is urgent.
Enhancing healthcare outcomes
Indonesian Food and Drug Authority (BPOM) chairperson Dr Taruna Ikrar said: "The approval of Recce Pharmaceuticals' Phase 3 clinical trial is an important advancement in expanding treatment options for diabetic foot infections in Indonesia.
"BPOM is committed to fostering the timely development of innovative therapies to address urgent health challenges.
“This collaboration reflects Indonesia’s mission to enhance healthcare outcomes for its population, and we are eager to see the trial’s impact on patients requiring effective, novel anti-infective treatments.”
About the trial
As a registrational Phase 3 clinical trial for DFIs, it will be one of the largest DFI studies in the world and the first of its kind across Indonesia.
It will be conducted as a double-blinded, placebo-controlled study evaluating R327G for the treatment of DFIs and is on track to begin mid-December.
The trial, which aims to enrol up to 300 patients (200 to receive R327G and 100 to receive placebo), will run for approximately 12 months, with an expected read-out in late 2025 and expected regulatory approval and commercial launch in the first half of 2026.
Stakeholder support
It is made possible thanks to the significant support of key Indonesian stakeholders, including the Indonesian Ministry of Health, Badan POM, PT Etana Biotechnologies and the Australian Government, accelerating R327G’s path to commercialisation.
The study will cost Recce around US$2 million before further subsiding by the Australian Government’s 43.5% R&D rebate scheme under the company’s Advanced Overseas Advanced Finding status with AusIndustry. All intellectual property is that of Recce.
Closer to commercialisation
Recce Pharmaceuticals chief executive officer James Graham said: “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.
"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.”
Progress in Australia
In Australia, with the Phase 2 Acute Bacterial Skin and Skin Structure Infections (ABSSSI) clinical trial in the final stages and on track to finish this year, Recce is expected to initiate a Phase 3 registrational study of R327G in the first half of 2025.
The Australian program will be in parallel across the ASEAN focused initially on DFIs allowing an expansive international strategy, bringing near-term revenue opportunities of ASEAN to the forefront.