Evaluation of Topical Pravibismane in Moderately Infected Diabetic Foot Ulcers: Safety, Tolerability, and Efficacy Outcomes in an Exploratory Phase 2 Study

Introduction: Diabetic foot infections (DFIs) are a major cause of diabetes-related hospitalizations and lower limb amputations. Pravibis- mane, the first drug in a new class, offers broad-spectrum anti-infective, anti-biofilm, and anti-inflammatory effects, potentially enhancing wound healing compared to standard of care (SoC) alone. This study aimed to assess the safety and tolerability of a 12-week course of topical pravibis- mane in subjects with moderate DFI, while selected secondary efficacy endpoints included complete wound closure and wound size reduction. Methods: This Phase 2, randomized, open-label, controlled study involved adult subjects with a moderately infected DFU ≥4 weeks old. Forty-seven subjects were randomized 2:1 to receive topical pravibismane (formerly MBN-101) plus SoC or SoC alone. The pravibismane group received topical pravibismane three times per week for up to 12 weeks. Results: Median age of subjects was 55.5 years and were mostly male. The DFI median wound size was 3.4 cm² with a median duration of 96.5 days. More subjects in the pravibismane group had a history of ≥2 prior amputations (30.0% vs. 6.3%) and higher stages of CKD (26.7% vs. 12.6%). No safety concerns were identified for pravibismane when applied top- ically for 12 weeks. All treatment-emergent adverse events and serious adverse events were unrelated to the study drug. Pharmacokinetic data showed no absorption or accumulation of pravibismane or its metab- olites. At end of treatment, an unadjusted analysis of subjects showed that 46.7% in the pravibismane arm achieved complete wound healing versus 31.3% in the SoC arm, a 15.4% difference favoring the pravibis- mane group (p=NS). The treatment difference was lower when adjusted for wound area. Conversely, an unadjusted ad-hoc analysis of subjects who did not receive systemic antibiotics as part of SoC showed a 32.6% treatment difference favoring the pravibismane arm (p=NS). At EOT, the median percent reduction from baseline in wound area was greater in the pravibismane arm (-98.5%) compared to SoC alone (-65.7%) (p=NS). Discussion: Topical pravibismane was safe and well-tolerated over 12 weeks of treatment. While the study was not powered for statistical effi- cacy, pravibismane showed a numerical advantage over SoC in complete wound closure and other efficacy endpoints. These results will guide future studies.