HREC Approves Comparator Study for Pivotal Phase 3 DFI

• HREC approves new study arm for Phase 3 DFI trial
• Randomised, active-controlled, non-inferiority study added
• R327G to be compared against physician-selected antibiotics

Recce Pharmaceuticals Ltd announced that the Human Research Ethics Committee (HREC) has approved an amendment to the protocol for its pivotal Phase 3 clinical trial of RECCE® 327 Topical Gel (R327G) for the treatment of Diabetic Foot Infections (DFI) in Australia. The amendment adds a randomised, active-controlled, non-inferiority study arm, enrolling a total of 208 participants randomised between R327G and a physician-selected antibiotic. This addition enables the company to generate comparative clinical data for R327G against established antibiotic treatment options used in the management of DFI. The amendment also allows participants randomised to R327G to receive treatment for each qualifying DFI they experience during the study, enabling multiple efficacy assessments to be captured per participant. The Phase 3 trial amendment positions R327G to go head-to-head against multiple existing antibiotics, generating comparative data relevant to its potential as a treatment for DFIs.