Recce Pharmaceuticals gains ethics approval for Phase 3 clinical trial in Indonesia [Video]

Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) CEO James Graham joins Proactive’s Tylah Tully to discuss the ethics approval the company has received for a Phase 3 Clinical Trial of RECCE® 327.

Recce has received Human Research Ethics Committee approval has been received to begin dosing in Indonesia for a Registrational Phase 3 clinical trial for its RECCE® 327 (R327G) topical gel, designed to treat diabetic foot infections (DFIs).

The large-scale, double-blinded, placebo-controlled trial, set to commence in mid-December, will involve up to 300 patients across Indonesia, with a 12-month study period. Results are anticipated by late 2025, with regulatory approval and commercial launch aimed for H1 2026.

The trial, supported by the Australian and Indonesian governments and facilitated by PT Etana Biotechnologies, represents a critical step in bringing R327G to market.

With an estimated cost of US$2 million, the trial will benefit from Australia’s R&D rebate scheme, reducing financial strain. Approval from BPOM, Indonesia’s food and drug authority, is expected soon.
The trial capitalises on Indonesia’s high diabetes prevalence and growing antimicrobial resistance needs. Approval in Indonesia could pave the way for further regulatory acceptance across ASEAN countries. Initial trials in Australia showed a 100% patient response rate, underscoring the potential of R327G to address severe infections in diabetic foot ulcers.

Recce has also reported significant progress in its Phase II clinical trial for R327G to treat Acute Bacterial Skin and Skin Structure Infections (ABSSSI). With 20 of the 30 patients now dosed, the trial shows promising results, as all dosed patients have met the primary endpoints of either a cure or marked improvement without any Serious Adverse Events (SAEs) reported.

The trial is set for completion by the end of 2024, reinforcing the potential of R327G in addressing critical unmet needs in bacterial infection treatment. The product’s development trajectory is strengthened by previous regulatory endorsements and encouraging interim data, indicating a strong efficacy and safety profile.

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