Recce Pharmaceuticals Receives Approval for Additional Phase II Trial of RECCE® 327 Topical Gel for Diabetic Foot Infections

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Recce Pharmaceuticals
Recce Pharmaceuticals
  • Human Research Ethics Committee (HREC) approval received to allow up to 20 additional patients access to RECCE® 327 Topical Gel (R327G) treatment under existing open-label study protocol

  • Program enables access to R327G for diabetic foot infections (DFI), following recent positive Phase II results in acute bacterial skin and skin-structure infections (ABSSSI), including diabetic foot ulcers (DFU)

  • Access focused on patients with DFU infections given the unmet medical need, as ~40% experience ulcer recurrence within a year of healing

  • The study will start now, running in parallel to Registrational Phase 3 in Indonesia for DFI and planned Registrational Phase 3 for ABSSSI in Australia, on track for H2 2025

SYDNEY, April 23, 2025 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q), (Recce or the Company), a leading developer of a new class of synthetic anti-infectives, today announced it received Human Research Ethics Committee (HREC) approval to build upon its open-label Phase II trial of RECCE® 327 Topical Gel (R327G) for the treatment of diabetic foot infections (DFI), enabling the enrollment of up to 20 additional patients.

“This approval allows us to build upon the strong clinical results of R327G and continue demonstrating its potential as a differentiated treatment for DFIs,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals. “We are pleased to continue to provide access to R327G to diabetic patients in need, and to further build out our data portfolio alongside our Phase 3 programs in both Australia and Indonesia.”

The use of R327G under this protocol follows strong interest by investigators encouraged by the highly promising results of the recently released Phase II data, where R327G demonstrated, after 7 days of treatment, 86% of patients had a successful clinical response (the primary endpoint also used by the U.S. FDA). At 14 days of treatment, >90% of patients achieved a primary efficacy endpoint.

The investigators of the trial have expressed confidence in R327G as a safe and well-tolerated therapeutic, particularly in difficult-to-treat infections such as DFIs, where standard treatments often fall short. Using a gel avoids systemic (oral & IV) antibiotics with their associated adverse effects. This study offers an opportunity to further strengthen the clinical profile of R327G while addressing the urgent needs of patients currently lacking effective treatment options.

The study will start now and run in parallel with Recce’s Indonesian Phase 3 trial, which remains on track to commence shortly. This program does not impact the initiation timeline of the Registrational Phase 3 DFI study in Indonesia or the planned Registrational Phase 3 ABSSSI study in Australia. The study is designed to run in parallel and is expected to generate additional data to support future regulatory submissions. The study will be conducted by Barwon Health, further supporting the Company’s clinical momentum in Australia.