Highlights:

  • Recce Pharmaceuticals was trading at AUD 0.38, flat during the afternoon Trading session on 19 August 2026.
  • The company received HREC approval for an amended Phase 3 trial protocol for RECCE 327 Topical Gel.
  • The amendment introduces a randomised active-controlled non-inferiority study arm involving 208 participants.
  • R327G will be compared against physician-selected antibiotics used in diabetic foot infection treatment.
  • Patient dosing and recruitment continue under the existing Phase 3 trial program.

Recce Pharmaceuticals Ltd (ASX:RCE) has received approval from Australia’s Human Research Ethics Committee (HREC) for a protocol amendment to its pivotal Phase 3 clinical trial of RECCE 327 Topical Gel (R327G) for the treatment of diabetic foot infections (DFI).

Recce Pharmaceuticals was trading at AUD 0.38, unchanged during the afternoon trading session on 19 August 2026, while the company’s shares remained down 7.32% over the past year. The latest update outlined changes to the clinical trial design aimed at generating comparative data against existing antibiotic treatment options.

Phase 3 Trial Gains Active-Controlled Study Arm

The approved amendment introduces a randomised, active-controlled, non-inferiority study arm for the Australian Phase 3 DFI trial.

The new study design will enrol 208 participants, with patients randomised between R327G and one of four physician-selected comparator antibiotics.

The comparison is intended to generate clinical data on R327G against existing antibiotic treatments currently used in the management of diabetic foot infections.

Recce stated that there is no specific existing standard of care for DFI treatment, with antibiotic selection typically influenced by factors including suspected pathogens, infection severity and patient-specific considerations.

Patient Recruitment and Treatment Continue

Recce confirmed that patient dosing is already underway under the Phase 3 trial protocol, with recruitment and treatment of patients with mild to moderate diabetic foot infections continuing.

The updated trial design allows participants randomised to R327G to receive treatment for each qualifying DFI experienced during the study period.

The company stated that this approach is intended to increase the Volume of efficacy data collected from eligible participants where applicable.

A planned interim analysis will be conducted by the Independent Data Monitoring Committee after 104 participants have been enrolled, randomised, treated and followed through the end of treatment or early withdrawal.

Additional Data Collection Through Wound Imaging

The amended protocol also introduces wound imaging using calibrated digital photography.

The imaging process is designed to provide standardised wound measurements and an additional objective assessment of infection outcomes alongside investigator evaluations.

Recce stated that the additional data collection is intended to strengthen the clinical data package supporting future regulatory submissions.

Global Regulatory Strategy Continues

The Australian Phase 3 program forms part of Recce’s broader global development strategy for R327G.

The company is also progressing a pivotal Phase 3 DFI program in Indonesia, with regulatory objectives covering Australia, the United States, the Middle East and North Africa (MENA) region and ASEAN markets.

Recce is developing R327G as a topical therapy targeting diabetic foot infections, alongside its broader synthetic anti-infective pipeline.

RECCE 327 Development Program

RECCE 327 is one of Recce’s synthetic anti-infective candidates being developed for serious infections caused by Gram-positive and Gram-negative bacteria, including antibiotic-resistant forms.

The company’s pipeline also includes RECCE 435, an orally administered therapy candidate for bacterial infections, and RECCE 529 for viral infections.

Recce stated that its synthetic anti-infective approach is designed to address challenges associated with antimicrobial resistance.

Management Commentary on Trial Progress

Recce Pharmaceuticals Chief Executive Officer James Graham said the protocol amendment reflects continued progress across the company’s Phase 3 clinical programs.

Mr Graham highlighted the continued involvement of trial sites and clinicians as patient dosing progresses and stated that the amendment would support generation of comparative data between R327G and standard antibiotic treatments.

The company continues working towards generating clinical data from its Phase 3 programs to support future regulatory activities.

Investor Takeaway

Recce Pharmaceuticals’ latest update highlights an expansion of its Phase 3 DFI trial design through the addition of an active-controlled comparison arm.

Investors may continue monitoring patient recruitment, interim analysis milestones, clinical data outcomes and regulatory progress across Australia, Indonesia and other targeted markets.