Microbion has announced positive topline results from its Phase II clinical trial evaluating pravibismane, a topical treatment for moderately infected chronic diabetic foot ulcers (DFU). The multi-center, randomized, open-label study, involving 46 subjects, demonstrated a favorable safety and tolerability profile over a 12-week treatment period followed by a four-week follow-up, with no adverse events linked to the therapy.
The trial, which randomized subjects in a 2:1 ratio to receive either topical pravibismane plus standard of care (SoC) or SoC alone, also showed encouraging trends in wound closure and reduction in wound size in the pravibismane group compared to SoC alone. While the study was not powered for statistical efficacy, these signals suggest potential clinical benefits.
Safety and Pharmacokinetics
In addition to the positive safety outcomes, pharmacokinetic data indicated no systemic exposure or accumulation of pravibismane. The treatment had no visible impacts on vital signs, haematology, clinical chemistry, electrocardiogram (ECG) parameters, or other lab findings.
Antimicrobial Activity
The trial also re-confirmed the therapy’s potency against a broad spectrum of drug-resistant bacterial isolates from subjects. All infections treated comprised multiple bacterial species, with key pathogens in diabetic foot ulcers, including antibiotic-resistant strains, were sensitive to this topical treatment.
Extended Regimen and At-Home Administration
The secondary objectives of the study included exploring signals of efficacy seen in previous clinical trials and assessing the operational feasibility of at-home administration of the topical medication. Microbion president and chief innovation officer Dr. Brett Baker stated, "We demonstrated the safety and feasibility of a much longer duration regimen and a higher drug concentration with over half of the treatments being self-administered by patients at home."
Potential for Wound Closure
Dr. Baker added, "The clinical efficacy signals further confirm topical pravibismane’s potential for achieving complete wound closure in chronic, long-standing wounds that are otherwise not responding to the current standard of care." He also noted that topical pravibismane has now consistently been shown to be safe and well-tolerated in six clinical studies involving over 350 human subjects.
The trial was partially funded by an award from the Naval Medical Research Command (NMRC) – Naval Advanced Medical Development (NAMD) through the Medical Technology Enterprise Consortium (MTEC).
