Recce Pharma Adds Comparator Arm to Phase 3 Diabetic Foot Trial

Recce Pharmaceuticals has won ethics approval to add an active-control arm to its Australian Phase 3 trial of RECCE 327 topical gel for diabetic foot infections, a move that gives the ASX-listed biotech a head-to-head data set against existing antibiotics.

The amended study will enroll 208 patients and randomize them between R327G and one of four physician-selected antibiotics. The non-inferiority design lets Recce test whether its synthetic polymer gel performs as well as standard treatments for diabetic foot infections, a condition that currently draws on antibiotics chosen case-by-case based on pathogen type, susceptibility, allergy history, and MRSA risk.

An interim analysis is planned after 104 patients finish treatment or withdraw. That early read – roughly half the study population – gives Recce a formal statistical checkpoint before the full enrollment.

The Australian trial runs alongside Recce's existing Phase 3 DFI program in Indonesia. Both are part of a broader regulatory push across multiple markets. R327G is the topical version of RECCE 327, one of three synthetic polymer anti-infectives in the pipeline alongside RECCE 435 and RECCE 529.