Lipella Pharmaceuticals Inc. — Department of Health and Human Services SBIR Phase I: NIAID

Description

ABSTRACT There are currently no reliable and objective urine based rapid detection point of care tests for mosquito borne diseases In this Phase proposal we will develop and optimize the U TEST a test for urine samples that can distinguish between infections of multiple mosquito borne viruses MBVs including Zika virus ZIKV Dengue virus DENV Chikungunya virus CHIKV and Yellow Fever virus YFV U TEST will not require trained personnel expensive equipment or a centralized laboratory and it is a rapid low cost option with high specificity that can be done in the field without electrical power and using room temperature urine without centrifugation We have completed initial testing of samples from a patient cohort in a current mosquito borne virus infection epicenter in partnership with Paramedics for Children International PFCI at a clinical facility in Cop n Ruinas Honduras This clinic treats over patients a year and sees patients daily with mosqui to borne diseases We have already received urine and blood samples from PFCI that we will use to val idate and optimize the U TEST We will run U TEST in the urine and blood samples and validate the positive and negative results with those results obtained with quantitative reverse transcription PCR qRT PCR that has already been completed and discussed in the preliminary data section Dr Chancellor is an expert in designing urine based biomarker assays and has an established track record of translating and commercializing evidence based laboratory inventions to the clinic The intellectual property of the technology being developed in this SBIR was developed by two of the co investigators Drs Michael Chancellor and Laura Lamb and is exclusively owned by Lipella with global rights This project is highly innovative and to our knowledge this is the first field based assay that can use simple voided urine that does not require centrifugation or refrigeration We have the necessary knowledge and proficiency to be successful in the on time completion of all the tasks of this grant Upon successful completion of this Phase project we will have completed proof of concept assay kit that will be ready for field testing and regulatory validation These results will lead to a well designed Phase proposal to assess the sensitivity specificity and predictive value of the diagnostic test in the real world clinical setting and hopefully the method can be adopted in a larger US regulatory trial for commercialization of the proprietary U TEST test PROJECT NARRATIVE Infection with Zika and other mosquito borne viruses is of growing concern Zika infection is anticipated to spread throughout the US and globally within the next year It has been reported to be transmitted sexually and by infected Aedes mosquitoes Our objective is to develop and field test a point of care non invasive urine based diagnostic test that can be used to monitor multiple mosquito borne viral infections that endanger both public health and military personnel