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Recce Pharmaceuticals Ltd (ASX:RCE)

ALERT: Price-sensitive ASX Announcement for RCE
Current share price for RCE : $0.335 -0.045 (-11.84%)+
Announcement
Release
19 Aug 2026 11:02AM
Price at Release
$0.380
Full Release
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Summary
Recce Pharmaceuticals Ltd announced that the Human Research Ethics Committee (HREC) has approved a protocol amendment for its pivotal Phase 3 clinical trial of RECCE® 327 Topical Gel (R327G) for treating Diabetic Foot Infections (DFI) in Australia. This amendment introduces a new randomized, active-controlled, non-inferiority study arm within the trial, involving 208 participants who will be randomized between R327G and a physician-selected comparator antibiotic. This study aims to generate comparative clinical data for R327G against established antibiotics used for DFI management. This approval strengthens Recce's global regulatory strategy, targeting approvals in Australia, the United States, MENA, and ASEAN regions. The trial will also incorporate wound imaging to enhance objective assessment data, supporting global regulatory submissions. Patient recruitment and treatment under the existing protocol are ongoing.
Key Points
  • HREC approved protocol amendment for pivotal Phase 3 DFI trial.
  • Introduction of a randomized, active-controlled, non-inferiority study arm.
  • 208 participants randomized between R327G and comparator antibiotics.
  • Study aims to generate comparative clinical data for R327G.
  • Strengthens global regulatory strategy across multiple regions.
  • Incorporation of wound imaging for enhanced data assessment.
  • Ongoing patient recruitment and treatment under existing protocol.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.