UrSure Inc. — Department of Health and Human Services SBIR Phase I: 105

Description

PROJECT ABSTRACT The overall goal of this SBIR project is to develop a point of carePOCplasma test to measure adherence to dolutegravirDTGa drug that virally suppresses HIV if taken adherentlyoverof daily doses takenHIV is a dangerous and prevalent disease globallycontributing to millions of infections and deaths per year and billions of dollars in healthcare costsHIV can be virally suppressed and those afflicted can lead relatively normal lives if the prescribed medications are taken dailybut adherence with the recommended dosing regimen is relatively poorMonitoring of drug adherence is well known to improve drug compliancebut there are no POC commercial products for adherence monitoring of DolutegravirHencethere is a critical unmet need for a rapid noninvasive inexpensive POC test to monitor recent DTG adherenceUrSure Incis an adherence company that develops tests to measure adherence with medication regimensand has previously established an adherence test for the antiretroviral drug Tenofovirwhich is taken as PreExposure ProphylaxisPrEP and Antiretroviral TherapyARTWe developed and validated a semiquantitative liquid chromatography tandem mass spectrometryLCMS MSurine assay with high sensitivityspecificity for tenofovirTFVone of the component drugs of PrEPin urineThe objectives of this Phase I project are to produce a novel DTG analoguse it to produce a novel mAb able to detect the drugand validate mAb stability on nitrocellulose for LFIA developmentUrSure has relationships in place with LFIA experts and organizations with deep experience in LFIA assay developmentvalidation and assay kit productionThe Specific Aims are toTo synthesize and characterize one DTG analogThis derivative will be conjugated to be used as immunogens for antibody production and conjugated to BSA to be used for ELISA developmentDevelop and selectmonoclonal antibodymAbcandidates able to detect DTG based on ELISA performance using plasma samples from healthy patient samples spiked with varying concentrations of metaboliteDemonstrate proof of principle by showing that the mAb is stable on nitrocellulose in the presence of metabolite spiked buffer samples and we can generate a curve that spans the critical clinical cutoff ofng mLThe final deliverables of this Phase I project will be the novel DTG analogimmunogennovel anti DTG mouse mAband validation that the mAB is stable for future LFIA developmentSuccessful completion of this Phase I project will result in the materials needed to produce the LFIA for the UrSure POC Dolutegravir adherence test in an anticipated future Phase II project PROJECT NARRATIVE DolutegravirDTGin combination with other antiviral medications is used in the treatment of HIVThis course of treatment is highly effectivehoweverthe regimen consists of daily pill ingestionand patients struggle with adherencewhichcombined with the high cost of HIVmakes this disease costly to payors around the worldSuccessful completion of this research program will result in a rapid point of care plasma test to monitor Dolutegravir usewhich will be used during clinic visits to encourage and increase drug adherenceIncreased adherence to DTG will lead to better viral load suppression for HIV infected patientssaving lives and costs both through treatment and the prevention of future infections and development of resistance