Recce Pharmaceuticals Limited (ASX:RCE) Secures Approval for Phase 3 Clinical Trial
Approval for Phase 3 Clinical Trial
Recce Pharmaceuticals Limited (ASX:RCE) has received approval from Indonesia’s Drug and Food Regulatory Authority to initiate a Registrational Phase 3 clinical trial for RECCE® 327, a topical gel aimed at treating diabetic foot infections. This trial will take place in Indonesia, which has one of the largest populations of diabetes patients globally.
Significance of the Trial
The approval represents a significant milestone for Recce as the trial follows earlier human ethics committee approval. The company is set to commence the trial this quarter, with the potential to pave the way for commercial opportunities across the ASEAN region. The trial is designed to evaluate R327G through a double-blinded, placebo-controlled format involving up to 300 patients.
Comments from the CEO
Recce Pharmaceuticals Chief Executive Officer, James Graham, stated, “This pivotal Phase 3 trial approval is a significant achievement, bringing us closer to commercialization and profitability.” He also acknowledged the support from various stakeholders including the Australian Government.
Looking Ahead
The trial is expected to run for approximately 12 months, with readouts anticipated in late 2025. The commercial launch is projected for the first half of calendar year 2026. Recce aims to expand its international strategy with additional trials planned in Australia next year.
Motley Fool contributor Abbie Stokes has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
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