Recce Pharmaceuticals Ltd has announced positive results from its Phase II clinical trial evaluating RECCE® 327 Topical Gel (R327G) for the treatment of acute bacterial skin and skin structure infections (ABSSSI), including diabetic foot infections (DFI). The trial achieved a 93% primary efficacy endpoint over 14 days, meeting all study endpoints and supporting progression to Phase III trials.
The open-label trial enrolled 30 patients, with 29 included in the final data analysis. One patient was withdrawn due to pre-existing pain at the wound site unrelated to R327G. The study evaluated the safety, tolerability, efficacy, and plasma pharmacokinetics of R327G when applied directly to the infected area.
Efficacy and Safety Results
After seven days of treatment, 86% of patients (25 out of 29) treated with R327G had a successful clinical response. By day 14, 93% of patients (27 out of 29) achieved the primary efficacy endpoint. The trial also demonstrated that R327G was safe and well-tolerated, with no serious adverse events reported.
James Graham, CEO of Recce Pharmaceuticals, 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."
Phase III Trial Plans
Based on the Phase II results, Recce Pharmaceuticals is moving forward with registrational Phase III trials. A Phase III trial for DFIs has been approved by the Indonesian Drug and Food Regulatory Authority (Badan POM) and is set to begin in mid-December. The company also plans to initiate a Phase III study of R327G in Australia for ABSSSI, which will serve as a registrational trial for the U.S. Food and Drug Administration (FDA) and Australian Therapeutic Goods Administration (TGA).
The Indonesian trial will be one of the largest DFI studies in the world and the first of its kind across Indonesia, potentially bringing forward commercial opportunities for the company in the ASEAN region. Driven by the high response rates in the Phase II study, experts have determined that the Phase III DFI study can meet a statistically significant positive endpoint after completing approximately 100 patients, compared to the study baseline of 300 patients. The company anticipates completing this data set by the end of the year.
Addressing Antimicrobial Resistance
The data from this trial aligns with the FDA’s increased demand for novel broad-spectrum antibiotics to address antimicrobial resistance (AMR). ABSSSIs, including DFIs, necrotizing fasciitis, and post-operative wound infections, present a considerable challenge to the healthcare system. Alan Dunton, MD, Director & Chief Medical Advisor of Recce Pharmaceuticals, noted that the results reflect the broad-spectrum nature and rapid onset of effect of R327G, positioning the company well for the upcoming Phase 3 trials. He also emphasized that Recce has demonstrated that its R327 anti-infective compounds are effective in vitro against diverse species of bacteria, including over 500 clinical isolates, many of which were previously considered drug-resistant.
Market Opportunity
The global ABSSSI treatment market was valued at $7.3 billion in 2018 and is projected to reach $26 billion by 2032, representing a compound annual growth rate of 9.5% between 2019 and 2032. Recce Pharmaceuticals aims to address this substantial commercial opportunity with its innovative anti-infective technology.
