Recce Pharmaceuticals (ASX:RCE) received approval from Indonesia's Drug and Food Authority to start a registrational phase 3 clinical trial of its Recce 327 topical gel in diabetic foot infections, according to a Monday filing with the Australian bourse.
The synthetic anti-infectives developer received expedited regulatory review status from the Indonesian regulator, fast-tracking the trial and advancing commercial prospects in the Association of Southeast Asian Nations (ASEAN) region.
The approval follows recent ethics committee clearance to start patient dosing, allowing the company to proceed with the trial this quarter, the filing said.
Recce Pharmaceuticals is set to start a phase 2 trial of Recce 327 in mid-December. The double-blinded, placebo-controlled study will enroll 300 patients and run for 12 months, with results expected in late 2025. Regulatory approval and a commercial launch are targeted for the first half of 2026.
The study will cost $2 million, with subsidy support from Australia's R&D rebate scheme. Recce retains full intellectual property rights, the filing added.
The company also plans a phase 3 registrational study of Recce 327 in Australia in the first half of 2025. A parallel program will also start in ASEAN countries, targeting diabetic foot infections and boosting international growth opportunities.
Recce Pharmaceuticals' shares rose past 2% in recent Monday trade.
Price (AUD): $0.48, Change: $+0.01, Percent Change: +2.12%
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