Recce Pharmaceuticals advances diabetec foot infection trial

• Recce Pharmaceuticals received approval to advance its Australian diabetic foot infection trial to a pivotal Phase 3 study.
• The expansion broadens patient eligibility to include moderate infections, increasing the addressable population to approximately 80%.
• The company aims to use data from the study to support future international regulatory approval applications.

Recce Pharmaceuticals (ASX:RCE) received ethical approval to advance its Australian diabetic foot infection trial to a 200-patient Phase 3 study.

This expansion follows previous Phase 2 trial data that demonstrated a 93% primary efficacy rate at Day 14.

“We are moving with pace towards global registration,” said Recce Pharmaceuticals CEO James Graham.

The company stated that it is targeting full patient enrolment for the expanded clinical study by the end of 2027.

Following the announcement, the Recce Pharmaceuticals share price was up at $0.48.

The study protocol now includes moderate cases and infected ulcers below the knee to accelerate patient recruitment.

The programme forms part of a dual registration strategy also operating in Indonesia to target multiple global markets.