Recce Pharmaceuticals announced positive interim efficacy data and safety approval to continue its Phase II clinical trial of RECCE 327 Topical Gel (R327G) for Acute Bacterial Skin and Skin Structure Infections (ABSSSI), including diabetic foot infections. The independent non-Data Safety Monitoring Board (non-DSMB) unanimously agreed that R327G is safe and well-tolerated, demonstrating highly encouraging efficacy results.
The Phase II trial, titled "An Open-label, Pilot Efficacy Study and Exploratory Evaluation of the Systemic Bioavailability of Single and/or Multiple Doses of R327 as a Topical Gel Applied to Acute Bacterial Skin and Skin Structure Infections," is designed to evaluate the efficacy and systemic absorption of R327G when applied directly to the infected area. All patients who completed the treatment achieved a positive primary endpoint, showing either complete cure or improvement, with some experiencing complete cure as early as 7 days. These outcomes were measured using the Lipsky Clinical Resolution of Infection Scale, a tool recognized by the FDA for assessing the resolution of infections, particularly in diabetic foot infections.
Safety and Efficacy
The non-DSMB review found no safety concerns, with no serious adverse events (SAE) observed in patients. One patient was discontinued due to pain at the wound site, which was judged unlikely to be related to R327G. The conditions treated included diabetic foot ulcer, eczema, and scratch and puncture wound infections. A wide variety of infecting bacteria (Gram-positive and Gram-negative) were isolated and successfully treated with improvement/cure of infection in all patients that continued with their treatment.
Clinical Insights
Professor Eugene Athan, Coordinating Principal Investigator of the study, stated, "We're seeing some very promising results from the interim data in the Phase II trial, which confirm the safety and potential efficacy of R327G in treating Acute Bacterial Skin and Skin Structure Infections, including diabetic foot infections."
Market Opportunity
The global ABSSSI treatment market was valued at $7.3 billion USD in 2018 and is projected to reach $26 billion USD by 2032, representing a CAGR of 9.5% between 2019 and 2032.
Company Statement
CEO James Graham commented, "We are extremely encouraged by the feedback from the non-Data Safety Monitoring Board and the ongoing safety and efficacious profile of R327G. The absence of serious adverse events, coupled with the wide range of broad-spectrum efficacy across challenging wound infections, reinforces the potential of R327G to address unmet medical needs in the treatment of serious bacterial infections."
