Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has a green light from the Human Research Ethics Committee to start a registrational Phase 3 clinical trial in Indonesia for its RECCE® 327 (R327) topical gel for treating diabetic foot infections (DFIs), with commercialisation on track for 2026.
The company's CEO James Graham said: “Today marks the achievement of a landmark milestone in Recce’s clinical program development.
"We are thankful for the unparalleled support from our Indonesian partners in bringing our innovative anti-infective therapy to patients in need.
"This welcomed approval signals the beginning of our clinical programs in Indonesia and the broader ASEAN region, bringing Recce one step closer to commercialisation.
"We look forward to evaluating R327G in our first Phase 3 trial.”
Large-scale, late-stage trial
The pioneering anti-infective gel was designed to address challenging bacterial infections that are resistant to existing treatments – this approval sets the stage for the large-scale, late-stage clinical trial of the treatment to take place.
A Phase 3 trial will be conducted as a double-blind, placebo-controlled study across Indonesia, a country with one of the world’s largest populations affected by diabetes.
The trial will enrol up to 300 patients, 200 of whom will receive R327G while 100 will receive a placebo.
Dosing is set to kick off in December and the study is expected to run for just on 12 months, with final data anticipated in late 2025 and potential regulatory approval and a commercial launch targeted for the first half of 2026.
Strategic bilateral support
This trial is supported by both Australian and Indonesian government initiatives, as well as local clinical collaboration with PT Etana Biotechnologies.
The study will initially be conducted at PT Siloam International Hospitals, Indonesia’s largest private hospital network, which operates facilities in multiple cities.
The clinical program is projected to cost around US$2 million, with costs offset under the Australian Government’s 43.5% R&D rebate scheme.
Following ethics approval, Recce expects the second step of the Indonesian approval process – authorisation from Indonesia’s regulatory agency, Badan POM – to proceed shortly.
Success in this trial could enable Recce to extend R327G’s availability to other ASEAN countries, including Malaysia, the Philippines, Singapore and Thailand, where DFI treatment has an estimated market value of US$1 billion annually.
Global health challenge
Recce’s R327G topical gel is part of a broader pipeline of treatments aimed at overcoming antibiotic-resistant infections.
DFIs are a significant complication for diabetic patients, with roughly 50% of diabetic foot ulcers becoming infected, which can lead to severe health consequences, including amputation.
The global DFI treatment market is valued at around US$5.2 billion, with Indonesia alone accounting for an estimated US$189 million annually, given that 11% of its population is affected by diabetes.
R327G’s multi-layered mechanisms of action offer potential advantages over traditional antibiotics, addressing both Gram-positive and Gram-negative bacteria, including antibiotic-resistant strains.
The gel has shown 100% response rates in an Australian study for Acute Bacterial Skin and Skin Structure Infections (ABSSSIs), which demonstrates its efficacy in treating infections in high-risk patients.
About Recce Pharmaceuticals
Recce’s pipeline includes several synthetic anti-infective candidates, with the FDA having granted R327 Qualified Infectious Disease Product designation under the GAIN Act, which provides Fast Track Designation and market exclusivity post-approval.
The World Health Organization (WHO) recognises Recce’s R327, R435 and R529 in its global development list for priority pathogens combatting antimicrobial resistance.
The company’s fully automated manufacturing also supports its ongoing trials.