IONIC PHARMACEUTICALS, LLC — Department of Health and Human Services SBIR Phase I: 300

Description

ABSTRACT This proposal describes the development of the HydrAid Burn Dressing a novel hydrogel based burn wound dressing that absorbs exudateprotects the wound from bacterial infection and can be easily removed from the wound surface of and degree burn without causing trauma to the wound or pain to the patientBurns are one of the most common and devastating forms of traumaEach yearmore thanpeople worldwide die from fire related burn injuries and millions more suffer from burn related disabilities and disfigurements with psychologicalsocialand economic effects on both the survivors and their familiesBurn dressing removal is reported to be the time of most painafter the burn itselfand opioids continue to be the mainstay of treatment for burn patientsThe duration of a burn dressing change in a typical injury requiring ICU OR level care is often at leastminutes with induction of general anesthesiaand can extend to more than three hours depending on the caseAt presentall clinically available dressings adhere to the wound surface so that each change of dressing leads to traumatization of newly formed tissues on the outer layer of the bodyandapos s surfacedelayed healing and excruciating pain for the injured patientThe HydrAid Burn Dressing is composed of an amine terminated dendron and a bifunctional NHS activated PEG containing an internal thioester that react with each other to form a thioester linked hydrogel dressing that can be subsequently dissolved by exposure to an aqueous thiol solution via a thiol thioester exchange mechanismPreliminary data demonstrateour ability to synthesize the HydrAid Burn Dressingon demand dissolution of the HydrAid Burn Dressing by application of a cysteine methyl ester solutionlack of in vitro cytotoxicity or macrophage activation when exposed to the HydrAid Burn Dressingnew data in response to reviewer comments demonstrates comparable healing to traditional bandagesdissolution of the dressing in vivo on and degree burnefficacy in preventing bacterial infection innd degree burn wounds treated with the HydrAid Burn Dressingandeasyspray onapplication for completely covering the intricate surfacesdigitsand webbing of a human handTwo key Go No Go inflection points in the development of this technology arerigorous evaluation of whether the HydrAid Burn Dressing will prove beneficialor at least non harmfulto wound healing in a model relevant to human skine gpigsandwhether the synthesis can be scaled to produced material on a largegscale while satisfying analytical testing protocols that would be appropriate for subsequent GMP manufactureThis proposal address these two key questions through the following aimsAimDetermine the impact of the HydrAid Burn Dressing on wound healing in a second degree burn wound model in pigsAimScale up production to theg scale and develop analytics in house at Ionic PharmaSuccessful completion of these aims will enable a clear Go No Go decisiondefined by prospective milestonesregarding the feasibility and value of further development of this technology NARRATIVE Currently available burn wound dressings adhere to the wound surface and make each change of dressing excruciatingly painful for the patient and cumbersome and time consuming for clinical personnelThis proposal will develop a hydrogel based burn wound dressing that can be simply washed off the woundThis technology may provide economic benefitsreduced duration of wound dressing procedures with fewer staff requiredreduced pain for the patientincluding mitigating or removing the need for anesthesiaand may improve wound healing by averting additional trauma to the wound