Recce Pharmaceuticals ready for Phase 3 trial for R327G in Indonesia
09/12/2024
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Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) CEO James Graham joins Proactive’s Tylah Tully to discuss the approval the company has received from Indonesia’s Drug and Food Regulatory Authority (Badan POM) for a registrational Phase 3 clinical trial of RECCE® 327 topical gel (R327G) for treating diabetic foot infections (DFIs).
The trial will start in mid-December and represents a significant milestone for the company in the ASEAN region.
It will be conducted as a double-blinded, placebo-controlled study, enrolling up to 300 patients, with results expected in late 2025 and potential commercialisation in 2026.
The trial has support from Indonesian stakeholders, including the Ministry of Health and PT Etana Biotechnologies as well as the Australian Government. The project will cost approximately US$2 million, partially offset by Australia’s 43.5% R&D rebate.
This will be one of the largest DFI studies globally and the first in Indonesia, addressing urgent health challenges in a country with more than 19.5 million adults living with diabetes.
In Australia, Recce plans to launch a Phase 3 trial of R327G in 2025, aligning with its ASEAN-focused strategy.
These advancements bring Recce closer to commercialisation, with Graham acknowledging support from Australian and Indonesian authorities in expediting the process.
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