Phase 1b Data for Topical Pravibismane in Diabetic Foot Ulcer Infection Demonstrates Favorable Effects and Safety

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When utilized as an adjunctive therapy, topical pravibismane was safe, well-tolerated, and demonstrated favorable outcomes in a phase 1b trial in patients with moderate or severe diabetic foot ulcer infections.¹ The data was recently published in the International Wound Journal.²

Diabetic foot ulcers pose significant challenges in diabetes management, with infection being a major concern, and modern conventional treatments often face limitations due to antimicrobial resistance and impaired wound healing, according to authors of the study's manuscript.

In a phase 1b, randomized, multi-center, double-blind, placebo-controlled trial, researchers explored the safety and efficacy of topical pravibismane as an adjunct therapy for diabetic foot ulcers. Pravibismane is a novel broad-spectrum anti-infective agent targeting biofilm-associated pathogens.

Patients with moderate to severe diabetic foot ulcer infections received topical pravibismane or placebo in addition to standard care, with assessments conducted at various intervals over a 4-week period. Safety, wound size reduction, amputation rates, and microbiological responses were evaluated.

The trial enrolled 53 participants, with pravibismane demonstrating safety and tolerability profiles across all doses tested. Participants receiving pravibismane exhibited a progressive reduction in ulcer size, with a nearly 3-fold greater reduction compared to the placebo group.

Additionally, lower extremity amputation rates were considerably lower in the pravibismane-treated group. A microbiological evaluation demonstrated pravibismane's efficacy against a range of bacterial pathogens commonly associated with diabetic foot ulcer infections, including biofilm-forming strains.

Although the study was primarily focused on safety assessment, the observed reductions in ulcer size and amputation rates indicate potential clinical benefits of pravibismane adjunct therapy for diabetic foot ulcer infections.

"We are excited to share the results of this Phase 1b study that was designed mainly to assess the safety of topical pravibismane administration to DFI patients," said Benjamin Lipsky, MD, FACP, professor of medicine emeritus at University of Washington and first author of the study, in a news release. "We are pleased with the safety results and signals of clinical efficacy, which we believe warrant further clinical development of pravibismane in future studies. There is currently a major unmet need for new, easy to apply drug agents with multiple modes of activity to treat infection, and possibly help close, these infected, chronic wounds."

David Armstrong, DPM, PhD, professor of surgery at the Keck School of Medicine of University of Southern California and co-author of the study, echoed Lipsky's sentiments, reiterating the trial's promising outcomes.

"We are encouraged by the clinical efficacy signals demonstrated with pravibismane administration, such as greater wound size reduction, compared to placebo control," Armstrong said.² "Diabetic foot ulcers more than double a person's mortality risk that year and dramatically reduce quality of life. Occurrence of infections, especially antibiotic-resistant infections, within a chronic, persistent foot ulcer increases the risk of sepsis, and makes the ulcer even more difficult to treat, especially with the presence of infectious biofilms. We need new agents that promote faster closing of infected wounds because we are currently dependant on an expensive, time-consuming, two-pronged approach: firstly, use of systemic antibiotics to clear the infection; and then secondly, another agent, device, or advanced cellular or tissue therapeutic to attempt to close the wound."

References

1. Lipsky BA, Kim PJ, Murphy B, McKernan PA, Armstrong DG, Baker BHJ. Topical pravibismane as adjunctive therapy for moderate or severe diabetic foot infections: A phase 1b randomized, multicenter, double-blind, placebo-controlled trial. Int Wound J. April 3, 2024. Accessed April 8, 2024. https://doi.org/10.1111/iwj.14817
2. Microbion's topical pravibismane phase 1b moderate or severe diabetic foot ulcer infection study is published in International Wound Journal. News release. BioSpace. April 4, 2024. Accessed April 8, 2024. https://www.biospace.com/article/releases/microbion-s-topical-pravibismane-phase-1b-moderate-or-severe-diabetic-foot-ulcer-infection-study-is-published-in-international-wound-journal/