Recce Pharmaceuticals Commences Phase 3 Trial of Topical Gel for Diabetic Foot Infections

Recce Pharmaceuticals (ASX: RCE) has commenced patient dosing for a registrational Phase 3 clinical trial of its RECCE 327 topical gel (R327G) to treat diabetic foot infections (DFI).

The company has activated five clinical study sites across one of the world’s largest DFI patient populations in Indonesia, where estimates place the prevalence of diabetes at 20.9 million adults or approximately 11.3% of the nation’s adult population.

Recce expects to meet a “highly statistically-significant positive endpoint” after the dosing the first 155 patients in the Phase 3 trial, which the Indonesian and Australian governments as well as Indonesian biomedical collaborator PT Etana are supporting.

Lipsky Scale Responses

Up to 310 patients in the randomised trial will receive either R327G or placebo, with the primary objective of assessing clinical responses according to the Lipsky Scale, which the US Food and Drug Administration (FDA) recognises as a valid and reliable method for evaluating DFI treatment outcomes.

Secondary endpoints include a DFI total wound score and safety of R327G, including clinical observations and adverse events.

The Indonesian Drug and Food Regulatory Authority’s approved protocol requires an interim analysis of trial results as well as expedited regulatory review status.

An independent data management committee aims to complete this analysis and make recommendations early in the new year after which Recce will complete a submission for accelerated approval, with a targeted commercial launch of R327G before end-2026.

Global Rise in Diabetes

Recce chief executive officer James Graham said the Phase 3 trial was proceeding to plan.

“R327G is the first potential treatment for DFI and we see ourselves being well-positioned to meet infectious disease challenges amid the global rise in diabetes,” he said.

The company previously demonstrated R327G’s clinical efficacy in a Phase 2 trial on patients with acute bacterial skin and skin structure infections (including DFI), with participants reporting the drug as “very well tolerated” with no signs of any serious adverse events.

The results aligned with the FDA’s increased demand for novel broad-spectrum antibiotics to address antimicrobial resistance in skin infections.

Mr Graham confirmed that Recce designed the Phase 3 trial with minimal changes in order to replicate the Phase 2 findings.