Recce Pharmaceuticals (ASX:RCE) Reports Successful Phase II Trial Results
Clinical Trial Results
Recce Pharmaceuticals Ltd reported that its Phase II trial for RECCE®327 Gel achieved a 93% primary efficacy endpoint over 14 days in treating Acute Bacterial Skin and Skin Structure Infections (ABSSSI), including Diabetic Foot Infections (DFI). The report states that the gel was safe and well tolerated, with no serious adverse events.
Future Trials
The positive Phase II data supports the progression to Registrational Phase III trials in Indonesia and Australia. The Indonesian study expects interim analysis data by end of year 2025, potentially reducing patient numbers from 300 to approximately 100.
Executive Comments
CEO James Graham stated, “These impressive results underscore the potential of our topical gel to meet critical unmet medical needs in infection treatment. As we advance towards registrational Phase 3 trials in Indonesia, and Australia, we are encouraged by the rapid efficacy and strong safety outcomes demonstrated in this study. The global ABSSSI treatment market is a substantial commercial opportunity, valued at $7.3B USD in 2018 and expected to reach $26B USD by 2032, at a CAGR of 9.5% between 2019 and 2032. Going forward with our clinical programs, this gives us great confidence in addressing ABSSSI.”
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