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Highlights
- Recce Pharmaceuticals’ Phase II clinical trial of its topical gel, RECCE 327 (R327G), achieved a 93% primary efficacy endpoint in treating Acute Bacterial Skin and Skin Structure Infections, including Diabetic Foot Infections.
- The gel demonstrated strong safety results, with no serious adverse events reported, and a high success rate, with 86% of patients showing clinical improvement after seven days.
- Recce’s ongoing Phase 3 study for Diabetic Foot Infections is set to confirm a statistically significant endpoint with just 100 patients, a much smaller sample size than originally anticipated.
Recce Pharmaceuticals Ltd (ASX:RCE) has reported highly promising results from its Phase II clinical trial of the topical gel RECCE 327 (or R327G), designed to treat Acute Bacterial Skin and Skin Structure Infections (ABSSSI), including Diabetic Foot Infections. The trial achieved an impressive primary efficacy endpoint of 93% after 14 days of treatment, marking a significant milestone for the company's product development.
The efficacy was confirmed after seven days of treatment, with 86% of patients (25 out of 29) showing a successful clinical response. By the end of the 14-day treatment period, this response rate increased to 93%, with 27 out of 29 patients meeting the primary endpoint.
The gel was well tolerated by patients, with no serious adverse events reported during the trial. A total of 30 patients were enrolled in the study, with 29 included in the final analysis, following the withdrawal of one patient due to pre-existing pain at the wound site.
Given the strong clinical responses from this trial, experts have concluded that Recce’s ongoing Phase 3 Registrational Study for Diabetic Foot Infections will likely achieve a statistically significant positive endpoint with only 100 patients, significantly less than the initially planned 300 patients. This study is being conducted in Indonesia and is expected to be completed by the end of 2025.
CEO James Graham emphasized the importance of these results, stating, “These impressive results underscore the potential of our topical gel to meet critical unmet medical needs in infection treatment.” He also highlighted the substantial market opportunity for ABSSSI treatments, which was valued at $7.3 billion USD in 2018 and is projected to grow to $26 billion USD by 2032, at a compound annual growth rate (CAGR) of 9.5%.
In response to the news, Recce’s stock saw a notable rise, trading at 49c, up 8.89% since the market opened.
