Recce Pharmaceuticals Anticipates Key Clinical Trial Milestones for R327 Topical Gel
Key Insights
Recce Pharmaceuticals (search) expects completion of its Phase II ABSSSI (search) trial by the end of the year, with early results showing positive outcomes in treated patients.
Ethics approval has been granted to initiate a Phase III trial of R327G for Diabetic Foot Infections (search) in Indonesia, commencing in mid-December.
Successful results from the Indonesia trial could lead to regulatory approval and commercial launch in the ASEAN region by the first half of 2026.
Recce Pharmaceuticals (search) (ASX:RCE) is approaching two significant milestones for its R327 topical gel (R327G), with potential implications for the treatment of acute bacterial skin and skin structure infections (ABSSSI (search)) and diabetic foot infections (search) (DFIs). These milestones include the completion of a Phase II ABSSSI clinical trial and the commencement of a Phase III trial for DFIs in Indonesia.
Phase II ABSSSI Clinical Trial Completion
The Phase II ABSSSI (search) trial is in its final stages, with 20 of 30 patients already dosed. Patients receive R327G once daily for 7 to 14 days. The company anticipates completion by the end of the year. Recce has previously reported that all patients completing treatments have shown positive results on the primary endpoint, achieving either a complete cure or improvement, with some showing results in as little as 7 days. The ABSSSI market is projected to reach US$26 billion by 2032.
ABSSSI (search) encompasses conditions such as diabetic foot infections (search) (DFI), necrotising fasciitis, and postoperative wound infections. Success in this trial could pave the way for a pivotal Phase III trial in Australia or the United States, complementing the company’s recently announced Phase III clinical trial for Diabetic Foot Infections in Indonesia.
Phase III Trial for Diabetic Foot Infections in Indonesia
Recce Pharmaceuticals (search) recently obtained ethics committee approval to initiate a Phase III trial of R327G for Diabetic Foot Infections (search) (DFIs) in Indonesia. The trial is scheduled to begin in mid-December and will enroll 300 patients, with 200 receiving R327G and 100 receiving a placebo. The trial is expected to take 12 months, and successful results could lead to regulatory approval and a commercial launch of the product in the first half of 2026.
Indonesia and the broader ASEAN region present a significant opportunity due to the high prevalence of antimicrobial resistance (AMR (search)). Costs related to AMR are anticipated to reach US$550-700 billion without further interventions. Indonesia has a 12% prevalence of DFIs in hospitals and 24% in community settings, compared to 1.4% and 5.9% in the US, respectively. Approval in Indonesia would also grant Recce access to other ASEAN countries, including Malaysia, the Philippines, Singapore, and Thailand.
Even if further clinical trials are required for approval in the US and other jurisdictions, the commercial value gained from the Indonesian trial would be substantial and potentially less time-consuming than conventional Phase III trials.