Recce Pharmaceuticals

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Recce Pharmaceuticals has received approval from Indonesia's Drug and Food Authority for a registrational Phase 3 clinical trial of RECCE® 327 Topical Gel in Diabetic Foot Infections. This milestone allows the company to fast-track commercial opportunities in the ASEAN region and contribute positively to Indonesia's healthcare landscape. With over 19.5 million adults living with diabetes in Indonesia, the need for innovative therapies is urgent. The Phase 3 trial, one of the largest in the world for DFIs, will enroll up to 300 patients and is expected to have regulatory approval and commercial launch in H1 CY26.

The support of key stakeholders and the Australian Government has enabled this trial, showcasing Recce's commitment to addressing global health challenges. Additionally, the company is progressing with Phase 2 trials and plans to initiate a Phase 3 study in Australia in H1 2025, with a focus on ASEAN markets. CEO James Graham expressed optimism about these developments and the company's path to commercialisation.

Recce Pharmaceuticals has received approval from Indonesia's Drug and Food Authority for a registrational Phase 3 clinical trial of RECCE® 327 Topical Gel in Diabetic Foot Infections. This milestone allows the company to fast-track commercial opportunities in the ASEAN region and contribute positively to Indonesia's healthcare landscape. With over 19.5 million adults living with diabetes in Indonesia, the need for innovative therapies is urgent. The Phase 3 trial, one of the largest in the world for DFIs, will enroll up to 300 patients and is expected to have regulatory approval and commercial launch in H1 CY26.<br/><br/>The support of key stakeholders and the Australian Government has enabled this trial, showcasing Recce's commitment to addressing global health challenges. Additionally, the company is progressing with Phase 2 trials and plans to initiate a Phase 3 study in Australia in H1 2025, with a focus on ASEAN markets. CEO James Graham expressed optimism about these developments and the company's path to commercialization.<br/><br/>Investors are welcome to inquire further about this announcement and the company's strategic initiatives for addressing antibiotic-resistant superbugs and viral pathogens. This milestone signifies a significant step towards Recce's goal of combating antimicrobial resistance and bringing innovative treatments to patients worldwide.

Regulatory Approval for Registrational Phase 3 R327G Trial

Announcement summary