Recce Pharmaceuticals (ASX: RCE) Wins Approval for Phase 3 Comparator Study

Recce Pharmaceuticals has received Australian ethics approval to broaden its pivotal Phase 3 diabetic foot infection trial of R327G.

The amended design adds a randomised, active-controlled study comparing the topical gel with established antibiotics. It will enrol 208 participants.

Patient recruitment and treatment are continuing under the existing protocol. The new design will be implemented through the approved amendment.

A Direct Antibiotic Comparison

Participants will be randomised between R327G and one of four physician-selected comparator antibiotics. The study will assess whether R327G is non-inferior to those treatments.

A non-inferiority design evaluates whether a new treatment performs no worse than a comparator within a defined clinical margin. That creates a direct benchmark against antibiotics already used for diabetic foot infections.

There is no single existing standard of care for these infections, according to Recce. Treatment depends on the likely pathogen, antibiotic susceptibility and infection severity.

Doctors also consider prior antibiotic exposure, allergy history and the risk of methicillin-resistant Staphylococcus aureus. Treatment can then be refined using culture and sensitivity results.

Interim Review After 104 Patients

An Independent Data Monitoring Committee will undertake a planned interim analysis after 104 participants have progressed through the required process. They must be enrolled, randomised, treated and followed until treatment ends, unless withdrawn earlier.

The amended criteria also allow R327G recipients to be treated for each qualifying infection experienced during the study. Where applicable, this could generate multiple efficacy assessments from one participant.

Calibrated digital wound photography is also being introduced. This will provide standardised wound measurements alongside investigator assessments and support the regulatory data package.

Why the Design Matters

Head-to-head evidence can show how R327G performs against treatments that physicians already select in clinical practice. That comparison is more informative than evaluating the candidate without an active antibiotic control.

The Australian program also complements Recce’s ongoing pivotal Phase 3 diabetic foot infection program in Indonesia. Its broader regulatory strategy covers Australia, the United States, MENA and ASEAN markets.

Chief Executive Officer James Graham said: “We look forward to patient dosing continuing and generating data for R327G against standard of care antibiotics.”

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

R327G’s Broader Development Context

R327G is the topical formulation of Recce’s synthetic anti-infective candidate R327. The candidate is also being developed as an intravenous treatment for serious bacterial infections.

The US Food and Drug Administration has granted R327 Qualified Infectious Disease Product status. That designation provides Fast Track status and 10 years of market exclusivity after approval.

Recce wholly owns its automated manufacturing operations, which support its current clinical trials. The announcement did not provide a completion date for the amended Australian study.