Recce Pharmaceuticals

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Recce Pharmaceuticals has received Ethics Approval in Indonesia to begin a Registrational Phase 3 Clinical Trial of RECCE® 327 Topical Gel for Diabetic Foot Infections. This trial, set to start in mid-December, aims to enroll up to 300 patients and is expected to be completed in approximately 12 months, with a read-out in late 2025 and potential regulatory approval and commercial launch in the first half of 2026. The study is a bilateral initiative supported by the Australian and Indonesian Governments, with a cost of approximately US$2M to Recce before subsidy by the Australian government. Successful completion of the trial could lead to regulatory approval for R327G in the larger ASEAN region. The approval marks a significant milestone in Recce's clinical program development and brings them closer to commercialization. 

Recce Pharmaceuticals has received Ethics Approval in Indonesia to begin a Registrational Phase 3 Clinical Trial of RECCE® 327 Topical Gel for Diabetic Foot Infections. This trial, set to start in mid-December, aims to enroll up to 300 patients and is expected to be completed in approximately 12 months, with a read-out in late 2025 and potential regulatory approval and commercial launch in the first half of 2026. The study is a bilateral initiative supported by the Australian and Indonesian Governments, with a cost of approximately US$2M to Recce before subsidy by the Australian government. Successful completion of the trial could lead to regulatory approval for R327G in the larger ASEAN region. The approval marks a significant milestone in Recce's clinical program development and brings them closer to commercialization. Investors are encouraged to ask any questions they may have regarding this announcement.

Ethics Approval for Registrational Ph3 R327G Clinical Trial

Announcement summary