Microbion Corporation, a US-based clinical-stage pharmaceutical company, announced on Thursday that it has started a Phase two, randomised, controlled study to evaluate the safety and efficacy of topical pravibismane to treat patients with moderate infections of chronic diabetic foot ulcers (DFU).

The company is planning to enrol 54 subjects with chronic moderate DFU infections in the present phase two exploratory study comparing 12 weeks of pravibismane treatment plus standard of care versus standard of care treatment alone. The study's main objective is to assess the safety and tolerability of topical pravibismane, while the secondary objective is to explore key signals of efficacy demonstrated in an earlier study. These efficacy endpoints include complete wound closure, reduction in the number and extent of amputations, reduction in wound size, and resolution of infection. This study is being conducted at select wound care sites in Texas and California, and potentially other US sites in the future. More information about the study can be found on Clinicaltrials.gov (identifier number: NCT05174806).

Pravibismane is the first in a new class of anti-infective drugs demonstrating broad-spectrum potency against a wide range of multidrug-resistant bacteria, and biofilms ubiquitous in DFU infections and widely recognised as one of the leading causes of treatment failure. Topical pravibismane has been safe and well-tolerated in five clinical studies involving over 325 human subjects.