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Targeting bacteria, the innate response of the middle ear to infection, and host-pathogen interactions, using topical and transtympanic applications for the treatment of otitis media.

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41HD097038-01A1
Agency Tracking Number: R41HD097038
Amount: $217,605.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NICHD
Solicitation Number: PAR17-200
Solicitation Year: 2017
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-05-13
Award End Date (Contract End Date): 2021-04-30
Small Business Information
Maple Grove, MN 55311-1328
United States
DUNS: 074678703
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (763) 458-3789
Business Contact
Phone: (763) 458-3789
Research Institution
MINNEAPOLIS, MN 55455-0149
United States

 Nonprofit College or University

Otitis media is a world wide disease primarily affecting the pediatric population under the age ofyearsIt is the most common reason for pediatric care visits and antibiotic therapyOver prescription and poorcompliance have led to a reduced susceptibility of bacteria to antibiotics andconsequentiallyto recurrent and chronic ear diseasesClearlythere is a compelling need to investigate alternative therapeutic modalitiesThe middle ear is a large cavityIt makes use of components of the innate immune response to trap bacteriacontaining them for elimination by phagocytesHoweverthese components can also encapsulate bacteria and protect them by immune evasionWe will investigate the efficacy of a formulation for the treatment of otitis media that targets both the innate response of the middle ear to infection and the pathogenWe will first target host containment of bacteria to expose them to treatmentTreatment consists of a potent antimicrobial peptide and a key molecule of the early innate response of the middle ear mucosa to infectionBacteria will also be treated with an antibiotic corticosteroidBacterial resistance is a world wide health concernWe believe that our combination of antibiotic and non antibiotic modalities will be successful in eliminating bacteria in the middle earthereby helping to prevent recurrent and chronic infectionsNot only is there a need to challenge traditional pharmacologic treatmentsbut to develop non traditional methods of administration as wellThe conventional method of treating otitis media with oral antibiotics exposes other organs to the treatmentas well as the middle earTopical treatment would be ideal in that it would limit treatment to the middle ear and provide a greater concentration of the pharmacologic agent to the infected areaAnd because the treatment is administered as an eardropit can be applied at time of diagnosisthus ensuring complianceLike the skinthe tympanic membrane is impermeable to most substancesnecessitating a penetration enhancement vehicleA number of these have been studiedbut with limited successWe are using a penetration enhancement vehicle that has been well characterizedIt has been shown to pass the epidermis of the skin via pore formationand so should likely pass the epidermis of the tympanic membraneMoreoverit is not ototoxic to the sensory neural structures of the inner earOtitis media is world wide health concern that has broad reaching medical and socioeconomic challengesWe have designed a drug intended to more effectively eliminate bacteria from the middle ear in the acute stages of otitis mediapreventing recurrent and chronic infectionsWe are likewise investigating its topical transtympanic administration with a penetration enhancement vehicle that is a powerful solvent with potential for use in the treatment of otitis media and other ear diseases Otitis media is the number one reason for pediatric office visits and the most common illness for which antibiotics are prescribedBacterial resistance to antibiotics has created a critical need for new multidrug formulations and their topical delivery to the middle ear to replace the current treatment paradigm of systemic antibioticsIn this projectthe small business and academic partner will test the efficacy of an innovative drug combination that is based on many years of otitis media researchand test its transtympanic administration

* Information listed above is at the time of submission. *

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