Montana Patent of the Month – January 2022
Diabetes is a disease truly misunderstood by most of the population. When someone mentions diabetes, your first thoughts usually go to blood sugar levels and management through insulin and diet. But if left unchecked, diabetes can lead to serious side effects. For instance, many diabetics suffer nerve damage and this damage most often begins in the feet. This means the patient loses feeling and may not be able to tell if they’ve got a cut on their foot. This cut can quickly become infected as a reduced immune system is another symptom. A diabetic foot infection, if left untreated, can lead to amputation or spreading of the infection. With the increase in multidrug resistant organisms and pathogens, treatment of these infections is getting increasingly harder.
Microbion, Corp. is a clinical-stage pharmaceutical company developing a novel class of compounds for the treatment of difficult-to-treat infections, including chronic infections and antibiotic-resistant infections. As part of this effort, the company has developed a bismuth-thiol formula to treat wounds.
The compound can be applied topically to the wound, including diabetic foot infections. The formula can effectively prevent the microbial infection from spreading or replicating. This is achieved by the formula’s inclusion of dual broad-spectrum antimicrobial and antibiofilm effects. These effects allow it to effectively kill even the most common antibiotic resistant species.
Effects have been monitored in a Phase 1b/2a clinical study, evaluating the effectiveness and safety in 52 patients. These studies showed great tolerability and no Treatment Emergent Adverse Events or Serious Adverse Events. Overall, the compound was seen to reduce wound size and amputation rate compared to the placebo.
Since then, their formula, formally called MBN-101, has been granted Qualified Infectious Disease Product (QIDP) designation and Fast Track designation by the US FDA for: (1) adjunctive treatment of moderate and severe diabetic foot ulcer infection; and (2) treatment of post-surgical orthopedic implant infections.
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