Patient Dosing Complete in Phase II ABSSSI Trial of R327G
| Stock | Recce Pharmaceuticals Ltd (RCE.ASX) |
|---|---|
| Release Time | 21 Jan 2025, 9:57 a.m. |
| Price Sensitive | Yes |
Recce Pharmaceuticals Completes Patient Dosing in Phase II ABSSSI Trial
- All 30 patients dosed in Phase II trial of RECCE® 327 topical gel (R327G) for Acute Bacterial Skin and Skin Structure Infections
- Preliminary data shows patients experienced complete cure or significant improvement in infection symptoms
- Full Phase II results expected in Q1 2025, with Phase III registrational trial to be initiated in H1 2025
Recce Pharmaceuticals Ltd has announced the successful dosing of all 30 patients in its Phase II clinical trial of RECCE® 327 Topical Gel (R327G) for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI). The open-label Phase II trial was designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of R327G when applied once daily for 7 or 14 days to areas infected by ABSSSI. Interim data from the trial has demonstrated a positive safety profile for R327G, with no Serious Adverse Events reported, and patients achieving favorable outcomes. The full set of clinical data will be reviewed by the Data Safety Monitoring Board, with the complete Phase II results expected to be announced in Q1 2025. Recce plans to initiate a Phase III registrational study of R327G in Australia in the first half of 2025, which will serve as a pivotal trial for regulatory approvals from the US FDA and Australian TGA. Separately, the company has also received approval to commence a Registrational Phase III clinical trial assessing R327G for the treatment of diabetic foot infections (DFIs) in Indonesia, which will be one of the largest DFI studies globally. The ABSSSI market is a significant opportunity, with the global treatment market size projected to reach $26 billion USD by 2032, representing a CAGR of 9.5% between 2019 and 2032. ABSSSI infections present a considerable challenge, and there remains a crucial need for new broad-spectrum antibiotics like R327G that can address both Gram-positive and Gram-negative pathogens.
Recce Pharmaceuticals expects to initiate a Phase III registrational study of R327G in Australia in the first half of 2025.
Recce Pharmaceuticals plans to initiate a Registrational Phase III clinical trial assessing R327G for the treatment of diabetic foot infections (DFIs) in Indonesia, which will be one of the largest DFI studies globally and the first of its kind across the ASEAN region.