Recce Pharmaceuticals Expands Phase 3 Diabetic Foot Trial With Comparator Arm

Recce Pharmaceuticals (ASX: RCE) has received Human Research Ethics Committee (HREC) approval to expand its pivotal Australian Phase 3 trial of RECCE 327 topical gel (R327G) for diabetic foot infections (DFI) with a new randomised active-controlled non-inferiority arm.

The amended study will enrol 208 participants and compare R327G directly with one of four physician-selected antibiotics used in DFI treatment, generating head-to-head clinical data against existing therapeutic options.

Patient recruitment and dosing are continuing under the existing protocol while Recce prepares to implement the amendment, with mild to moderate DFI patients already participating in the study.

The expanded Australian trial sits alongside Recce’s ongoing pivotal Phase 3 DFI program in Indonesia and forms part of its broader regulatory strategy across multiple international markets.

Deeper Clinical Data

Participants in the new arm will be randomised between R327G and a physician-selected comparator antibiotic, allowing Recce to assess whether its topical treatment is non-inferior to established antibiotics used to manage DFI.

The amended inclusion criteria will allow participants assigned to R327G to receive treatment for each qualifying DFI experienced during the study, potentially generating multiple efficacy assessments from individual participants where applicable.

An interim analysis is planned once 104 participants have been enrolled, randomised, and treated, and have either completed follow-up to the end of treatment or withdrawn prematurely.

Recce considers the head-to-head design important because DFI treatment currently draws on different antibiotics selected according to factors including the causative pathogen, antibiotic susceptibility, infection severity, and individual patient considerations.

Digital Wound Imaging

The updated protocol introduces calibrated digital wound imaging to provide standardised objective measurements alongside investigator assessment of the infection.

Treatment selection for DFI can also be influenced by prior antibiotic exposure, allergy history and the risk of methicillin-resistant Staphylococcus aureus, with therapy refined where appropriate using culture and sensitivity results.

Recce is aiming to generate a comparative data package that can support regulatory submissions and evaluate R327G against antibiotics already used by physicians for DFI.

“This protocol amendment reflects the significant advancements being made in our Phase 3 clinical programs, with continued engagement from trial sites and clinicians,” chief executive officer James Graham said.

“R327G has the potential to become the first standard of care used by physicians for the treatment of DFIs.”

Global Development Program

The Australian study expands a broader pivotal Phase 3 development program that includes Recce’s existing DFI work in Indonesia.

R327G is the topical formulation of RECCE 327, one of three patented broad-spectrum synthetic polymer anti-infectives in Recce’s development pipeline, alongside RECCE 435 and RECCE 529.

Recruitment and treatment will continue while the newly approved comparator amendment is introduced, with the planned interim analysis providing an early formal assessment after half of the 208-patient study population has completed the required treatment-stage follow-up.

“We look forward to patient dosing continuing and generating data for R327G against standard of care antibiotics,” Mr Graham added.