Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has secured Australian Human Research Ethics Committee (HREC) approval for a further protocol amendment to its pivotal Phase 3 trial of RECCE® 327 Topical Gel (R327G), adding a 208-patient active-controlled study arm in diabetic foot infections (DFI).
The new randomised, non-inferiority arm will compare R327G directly with physician-selected antibiotics currently used to treat DFIs, generating comparative clinical data as Recce advances the treatment through its international regulatory program.
The amended trial will randomise 208 participants between R327G and 1 of 4 physician-selected comparator antibiotics, providing a head-to-head assessment against established treatments used in DFI management.
Patient dosing, recruitment and treatment are already underway under the existing Phase 3 protocol, including patients with mild to moderate DFIs, ahead of implementation of the newly approved amendment.
An interim analysis is planned after 104 participants have been enrolled, randomised, treated and followed through to the end of treatment or withdrawn prematurely.
The amended inclusion criteria will also allow participants receiving R327G to be treated for each qualifying DFI experienced during the study, potentially enabling multiple efficacy assessments to be collected from individual participants.
Phase 3 DFI project
The updated protocol introduces calibrated digital wound imaging to provide standardised measurements alongside investigator assessments, adding another objective measure to the clinical data package intended to support regulatory submissions.
Recce said the Australian study complements its ongoing pivotal Phase 3 DFI program in Indonesia and forms part of a broader development and regulatory strategy covering Australia, the United States, the Middle East and North Africa, and ASEAN markets.
Chief executive officer James Graham said the amendment would allow the company to generate data comparing R327G with existing antibiotics.
“We look forward to patient dosing continuing and generating data for R327G against standard of care antibiotics. R327G has the potential to become the first standard of care used by physicians for the treatment of DFIs.”