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Recce Pharmaceuticals Ltd (ASX:RCE) has yielded positive data on the effectiveness of its topical gel in treating Acute Bacterial Skin and Skin Structure Infections, including patients with Diabetic Foot Infections, with a primary efficacy endpoint of 93% achieved during its Phase II clinical trial.
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This endpoint for the gel – known as RECCE 327 (or R327G) – was confirmed after 14 days of treatment. After seven days, 86% of patients (or 25 out of 29) had a successful clinical response after being treated with the gel.
After 14 days, 93% (or 27 out of 29) achieved a primary efficacy endpoint.
The gel was found to be safe and well tolerated, with no serious adverse events reported.
Overall, 30 patients had been enrolled in the study, with 29 included in the final analysis, since one was withdrawn due to pre-existing pain at the wound site.
Based on the strong responses from this trial, experts have decided Recce’s Registrational Phase 3 Study for Diabetic Foot Infections – ongoing – will be able to confirm a statistically significant positive endpoint after the completion of around 100 patients, much less than the study baseline of 300 patients.
The latter is being undertaken in Indonesia, the company has now confirmed.
Recce is expecting to complete the data for this by the end of 2025.
“These impressive results underscore the potential of our topical gel to meet critical unmet medical needs in infection treatment,” CEO James Graham said.
“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 programs, this gives us great confidence in addressing ABSSSI.”
Recce traded at 49c this morning, up 8.89% since the market opened.
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