Bismuth-thiol compositions and methods for treating wounds
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Publication Number
US-11207288-B2
Publication Date
2021-12-28
Expiration Date
Abstract
The invention relates to bismuth-thiol compounds and pharmaceutical preparations thereof. The invention further relates to methods for treating a topical wound, comprising administering to a subject in need thereof a therapeutically effective amount of a composition comprising a bismuth-thiol compound, wherein the composition is applied to the infection. Methods for treating microbial infections such as diabetic foot infections are also provided.
Core Innovation
The invention relates to therapeutic embodiments for treating or preventing diabetic foot infections and topical wounds using a composition comprising BisEDT. The composition is a suspension of microparticles comprising BisEDT, and the microparticles are defined by particle-size parameters including a D90 of less than 2 µm and that at least 70% of the microparticles have a volumetric mean diameter (VMD) from about 0.4 µm to about 2.5 µm.
The composition is applied to the infection, and the wound is described as healed or substantially healed within 12 weeks of the first administration. Additional embodiments include wound area applicability for diabetic foot infections and topical wounds, with the wound area described as from about 0.1 cm2 to about 250 cm2, and wound reduction outcomes described in terms of percent wound-size reduction to elimination within 12 weeks.
Biological mechanisms described in support of efficacy include disruption, impairment, or prevention of bacterial and fungal biofilms, including biofilm growth and formation, spread, invasiveness/pathogenicity, exotoxin secretion prevention, inhibition of planktonic cell viability, and prevention of post-debridement biofilm reformation. The document also states a combination-therapy context in which BisEDT is used with standard and non-standard diabetic foot infection therapies and antibiotics.
Claims Coverage
The partial content provides two independent method claims. Across these claims, the inventive subject matter is anchored by a BisEDT microparticle suspension with defined particle-size distributions, application to the infection/wound in subjects with diabetic foot infection, and time-bounded healing or elimination outcomes within 12 weeks for wound areas from about 0.1 cm2 to about 250 cm2.
BisEDT microparticle suspension for healing diabetic foot infection wounds
A method for healing a wound in a subject having a diabetic foot infection, comprising administering a therapeutically effective amount of a composition comprising BisEDT, wherein the composition is a suspension of microparticles comprising said BisEDT, wherein the microparticles have a D90 of less than 2 µm, wherein at least 70% of the microparticles have a volumetric mean diameter (VMD) from about 0.4 µm to about 2.5 µm, wherein the composition is applied to the infection and the wound is healed or substantially healed within 12 weeks of the first administration of the composition, and wherein the wound area is from about 0.1 cm2 to about 250 cm2.
BisEDT microparticle suspension for wound size reduction to elimination within 12 weeks
A method for wound size reduction in a subject having a diabetic foot infection, comprising administering a therapeutically effective amount of a composition comprising BisEDT, wherein the composition is a suspension of microparticles comprising said BisEDT, wherein the microparticles have a D90 of less than 2 µm, wherein at least 70% of the microparticles have a volumetric mean diameter (VMD) from about 0.4 µm to about 2.5 µm, wherein the composition is applied to the infection and the wound is reduced in size from about a 1% reduction relative to the original wound size to total elimination of the wound within 12 weeks of the first administration of the composition, and wherein the wound area is from about 0.1 cm2 to about 250 cm2.
Both independent claims cover BisEDT microparticle suspensions with specified D90 and VMD characteristics applied to diabetic foot infection sites, with therapeutic outcomes framed as healing/substantial healing or wound reduction to total elimination within 12 weeks.
Stated Advantages
Wound is healed or substantially healed within 12 weeks of the first administration of the composition.
Wound size is reduced from about a 1% reduction relative to the original wound size to total elimination of the wound within 12 weeks.
Reduced risk of amputation and/or infection-related surgery.
Potential benefits for reduced reinfection/relapse.
Fewer target-ulcer amputations and infection-related surgeries.
Improved ulcer size reduction and higher proportions of wounds with greater than 50% wound reduction.
Generally no significant differences in clinical and microbiological cure or biofilm score versus placebo.
Documented Applications
Treating or preventing diabetic foot infections and topical wounds using a BisEDT microparticle suspension applied to the infection site.
Healing diabetic foot infection-associated wounds and achieving healing/substantial healing within 12 weeks.
Reducing wound size to total elimination within 12 weeks in subjects having a diabetic foot infection.
Combination therapy context: using BisEDT with standard and non-standard diabetic foot infection therapies and antibiotics.
Biofilm impairment described for bacterial and fungal biofilms, including effects on biofilm growth and formation, spread, invasiveness/pathogenicity, exotoxin secretion prevention, planktonic cell viability inhibition, and post-debridement biofilm reformation prevention.
Adjunct BisEDT evaluated in diabetic foot infection, including assessments at test of cure, end of treatment, and end of study; measurement of biofilm score and wound outcomes using an 8-item DFI wound score and ulcer size from digital 3-dimensional photographs.
Topical treatment or method use for infected topical wounds, specifically diabetic foot infections and ulcers.
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