Phase II Clinical Trial Receives Additional Approval for DFI
| Stock | Recce Pharmaceuticals Ltd (RCE.ASX) |
|---|---|
| Release Time | 22 Apr 2025, 9:57 a.m. |
| Price Sensitive | Yes |
Recce Pharmaceuticals Receives Additional Approval for Phase II DFI Trial
- HREC approval received to enroll up to 20 additional patients with Diabetic Foot Infections (DFI) in existing open-label study
- Study aims to provide access to RECCE® 327 Topical Gel (R327G) for DFI treatment
- R327G demonstrated promising results in recent Phase II ABSSSI trial, including for Diabetic Foot Ulcer Infections
Recce Pharmaceuticals has received Human Research Ethics Committee (HREC) approval to enroll up to 20 additional patients with Diabetic Foot Infections (DFI) in its existing open-label Phase II clinical trial. This will allow for increased access to RECCE® 327 Topical Gel (R327G) as a treatment for DFI. The decision to expand the trial follows the recently released positive Phase II data for R327G in the treatment of Acute Bacterial Skin and Skin-Structure Infections (ABSSSI), including Diabetic Foot Ulcer Infections. The investigators have expressed confidence in R327G as a safe and well-tolerated therapeutic, particularly for difficult-to-treat infections like DFIs where standard treatments often fall short. The study will run in parallel with Recce's planned Registrational Phase 3 trials for DFI in Indonesia and ABSSSI in Australia, and is expected to generate additional data to support future regulatory submissions. The high recurrence rate of diabetic foot infections highlights the urgent need for new treatment options, and Recce is pleased to continue providing access to R327G for these patients.
The expanded Phase II DFI trial will run in parallel with Recce's planned Registrational Phase 3 trials for DFI in Indonesia and ABSSSI in Australia, and is expected to generate additional data to support future regulatory submissions.