Recce Secures Green Light From Indonesia For Phase 3 Trial Of RECCE® 327 Gel In Diabetic Foot Infections

Recce Pharmaceuticals Limited, a pioneer in developing a new generation of synthetic anti-infectives, has received authorization from Indonesia’s Drug and Food Regulatory Authority, Badan POM, to begin its Registrational Phase 3 clinical trial. This trial will evaluate RECCE® 327 in its topical gel form (R327G) for the treatment of diabetic foot infections (DFIs). This achievement builds upon the recent approval from the human ethics committee, allowing patient dosing to commence. 

Together, these approvals reflect Recce’s commitment to meeting stringent regulatory and ethical standards in Indonesia. With these milestones reached, the Company is set to initiate the Phase 3 trial as planned within this quarter. These developments mark a pivotal step forward for the Company’s expansion while also enhancing Indonesia's healthcare sector by paving the way for innovative treatments for infectious diseases. This progress aligns with Recce’s dedication to tackling pressing global health challenges with impactful solutions.

Dr. Taruna Ikrar, the Chairperson of the Indonesian Food and Drug Authority, said in a statement, "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.”

James Graham, Recce Pharmaceuticals Chief Executive Officer, mentioned, “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.”

Indonesia, home to over 19.5 million adults with diabetes, faces a critical need for advanced treatments targeting diabetes-related infections such as foot infections, urinary tract infections, and surgical site infections. Addressing this, Recce’s Registrational Phase 3 clinical trial for DFIs stands as one of the largest global studies in its category and a groundbreaking first for Indonesia.  

This double-blinded, placebo-controlled trial will evaluate the efficacy of R327G in treating DFIs. Scheduled to commence mid-December, the trial aims to enroll up to 300 participants—200 receiving R327G and 100 receiving a placebo—and is projected to run for approximately 12 months, with results anticipated by late 2025. Regulatory approval and commercial availability are targeted for H1 CY26.  

The study is propelled by robust collaborations with key Indonesian entities, including the Ministry of Health, Badan POM, PT Etana Biotechnologies, and support from the Australian Government. It also benefits from Recce’s Advanced Overseas Advanced Finding status with AusIndustry, reducing the US$2M trial cost by leveraging a 43.5% R&D rebate. Recce retains full intellectual property rights for R327G.  

Domestically, Recce is nearing the conclusion of its Phase 2 trial for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) and plans to launch a Phase 3 registrational study for R327G in Australia by H1 2025. This initiative aligns with a broader ASEAN-focused strategy, beginning with DFIs, to establish near-term revenue streams and expand Recce’s international presence.