Burn injury care has improved in the past decades, but complications still occur and lead to prolonged hospital stays and potentially to death. The risk of infection rises as a result of burns since the skin layers, which function as a barrier and prevent pathogens from accessing the susceptible body tissues, are no longer intact. Importantly, infections involving gram-negative or gram-positive pathogens are still the most common cause of mortality in burn injury patients. Although topical treatments exist, there is a need for an antiseptic that can effectively penetrate to the site of infection and that can be used for treatment of pathogens found in medical facilities. To address this need, CorMedix proposes to develop a combination of taurolidine encased in digestible nanosystems as topical treatment at burn sites. This proposed gel formulation will be administered to the skin surface and will penetrate through to the epidermal/dermal junction at which it will be digested by local tissue enzymes, releasing taurolidine, a taurine amino acid derivative with broad antibacterial action against gram-positive and gram-negative bacteria, mycobacteria and some clinically relevant fungi. CorMedix's proposed product will combine the proven antiseptic capabilities of taurolidine with effective delivery to the site of infection, allowing prevention and treatment of infections including those caused by pathogens that have already been found to be resistant to currently used antiseptics. CorMedix will develop this proposed product and demonstrate successful penetration of taurolidine to the site of infection through two Specific Aims.
In Specific Aim #1, a gel formulation with taurolidine containing nanoparticles will be developed by (1) Selection of a buffer that facilitates taurolidine stability during the nanosystem manufacturing process; (2) Selection of material for nanosystem surface (3); Testing of nanosystem susceptibility to subcutaneous tissue enzymes; and (4) Selection of gel matrix for suspension of nanoparticles.
In Specific Aim #2, the developed formulation will be tested in vitro using a Franz cells model.

Public Health Relevance

Burn injury care has improved in the past decades, but complications including bacterial infections still occur and lead to longer hospital stays and potentially to death. To address this need, CorMedix proposes to develop a topical treatment that will allow delivery of taurolidine, a proven antiseptic, to deeper layers of the skin at burn sites.

Agency
National Institute of Health (NIH)
Institute
National Institute of General Medical Sciences (NIGMS)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43GM122156-01A1
Application #
9407835
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Cole, Alison E
Project Start
2017-08-15
Project End
2019-02-28
Budget Start
2017-08-15
Budget End
2019-02-28
Support Year
1
Fiscal Year
2017
Total Cost
Indirect Cost
Name
Cormedix, Inc.
Department
Type
DUNS #
849818831
City
Bedminster
State
NJ
Country
United States
Zip Code
07921