Phase 1b Results: Topical Pravibismane Shows Promise for Diabetic Foot Infections
Summary: This phase 1b randomized, multi-center, double-blind, placebo-controlled trial assessed topical pravibismane—a novel broad-spectrum anti-infective targeting biofilm-associated pathogens—as an adjunct to standard care for moderate to severe diabetic foot ulcer (DFU) infections in 53 patients over 4 weeks. Primarily evaluating safety, the study also captured efficacy signals, revealing nearly 3-fold greater wound size reduction, lower amputation rates, and microbiological clearance of key pathogens compared to placebo. Well-tolerated across doses with no significant safety issues, pravibismane addresses antimicrobial resistance and biofilm challenges, potentially reducing reliance on systemic antibiotics and supporting faster wound closure in this high-risk population.
Key Highlights:
- Trial design: Double-blind, placebo-controlled; topical application over 4 weeks; primary endpoint safety/tolerability; secondary: wound reduction, amputations, microbiology.
- Efficacy: ~3x greater ulcer size reduction vs. placebo; reduced lower extremity amputations; effective against biofilm-forming bacteria in DFUs.
- Safety: Well-tolerated with no significant concerns; supports advancement to larger trials.
- Expert quote (Benjamin Lipsky, MD): “We are pleased with the safety results and signals of clinical efficacy, which we believe warrant further clinical development… There is currently a major unmet need for new, easy-to-apply drug agents with multiple modes of activity to treat infection.”
- Expert quote (David Armstrong, DPM, PhD): “We are encouraged by the clinical efficacy signals… We need new agents that promote faster closing of infected wounds because we are currently dependent on an expensive, time-consuming, two-pronged approach.”
- Future: Sponsored by Microbion; data published in International Wound Journal (April 3, 2024); plans for further development in DFI treatment.
Keywords: topical pravibismane, diabetic foot ulcer infection, biofilm targeting, wound size reduction, amputation prevention, Benjamin Lipsky, David Armstrong, Microbion