Eliaz Therapeutics, Inc. — Department of Health and Human Services SBIR Phase I: 300

Description

Project SummaryAbstract Sepsis and consequent acute kidney injuryAKIare major public health concernswith high mortality and morbidityand increasing incidenceDespite efforts to develop new interventionscurrent therapeutic options are limited in scope and effectivenessEliaz TherapeuticsETbased on substantial literature support and successful initial proof of concept in a porcine cutaneous inflammatory injury modeldirect our approach to depletion of the endogenous galectinGalprotein from septic patientsblood using a novel high affinity immunoadsorption apheresis columnGalis a known key driver of organ inflammation and fibrosis in numerous acute and chronic disorderswith substantial amelioration shown in experimental inhibition and GalmodelsGalwhile essential for initial immune pathogen recognition and immune activation in infectionsbecomes a driver of excessive and dysregulated cytokine responses in sepsis development and subsequent organ damageGalmodels showed reduced pathology and improved survivalWe hypothesize that selectively depleting Galby apheresis will exert synergistic therapeutic effects on both sepsis and sepsis related AKIOur intervention has potential to address the urgent need for mortality and morbidity reductionadvance sepsis AKI treatment options and expand applications in apheresis medicineET will test proof of concept of our device using a relevant rat model of sepsiscecal ligation and punctureWe will assess apheresis treatmentXGalcolumn feasibilityprocedural safety and tolerabilityand ability to suppress sepsis induced inflammation and kidney injuryindicated by increased survivalaltered inflammatory and kidney injury renal function markers and histological indication of reduced kidney fibrosis and macrophage infiltrationAimTo establish the time course of blood levels of Galand pertinent biomarkers in the circulation of septic ratsCecal ligation and punctureCLPwill induce sepsis via the robust inflammatory responseData will be used to determine correlation with Galinduction to select timing for Galdepletion for AIMstudyAimTo assess the safety and tolerability of the selective Galadsorption apheresis procedure in healthy ratsClinical observation of physiologyblood chemistrykidney and liver functionwill provide procedure tolerance and guidance on treatment duration for AIMstudyAimTo determine whether Galadsorption apheresis in a CLP rat sepsis model effectively reduces systemic levels of Galprotects against acutemodel induced kidney injuryreduces systemic inflammationand improves overall survival during sepsisSurvivalGallevels and selected biomarkers of sepsisinflammationfibrosisrenal injury function will be compared in active treatment vs sham groupsSuccessful results of Phase I studies will allow us to proceed to further preclinical studies and planned application for Phase II fundingwith the goal of FDA IDE application submissionand commercialization of the XGalimmunoaffinity adsorption apheresis column Eliaz Therapeutics Phase I SBIRProject Narrative This project aims to test the safety and feasibility of treating sepsis and sepsis induced acute kidney injury with a new medical device that removes galectinfrom a patient s blood with therapeutic apheresis treatmentThe novel concept is based on substantial literature support for the pivotal role of the galectinprotein in driving the excessive inflammation and dysregulated response to infection that makes sepsis AKI a life threatening condition with high mortality ratesincreasing incidenceand lack of effective treatments