Recce Pharmaceuticals gains crucial trial approval

Recce Pharmaceuticals (ASX:RCE) has received approval from Indonesia's Drug and Food Regulatory Authority to begin a Phase 3 clinical trial for its RECCE® 327 Topical Gel. This trial targets diabetic foot infections and is scheduled to start mid-December in Indonesia, involving up to 300 patients.

Recce Pharmaceuticals' strategic trial outlook

Recce Pharmaceuticals has secured approval for a Phase 3 trial of its RECCE® 327 Topical Gel in Indonesia, enhancing its market presence in a country with a large diabetic population. This trial, supported by significant stakeholders, underscores the need for innovative treatments for diabetes-related infections. With expedited regulatory review and potential financial support through the Australian R&D rebate, Recce aims to open commercial opportunities in ASEAN. Future plans include a similar trial in Australia, as Recce expands its anti-infective pipeline targeting antibiotic-resistant and viral pathogens.

Insights from key leaders on trial significance

The trial is a significant step in expanding treatment options for diabetic foot infections in Indonesia,' said Dr. Taruna Ikrar, Chairperson of Indonesia's BPOM. 'This approval represents a milestone for Recce's clinical development and commercialisation efforts,' commented James Graham, CEO of Recce.