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The CRIT-ICU Biomarker Panel for Stratification of Mortality Risk in ARDS Patients

Award Number: R41HL147769
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/15/2019
PERIOD OF PERFORMANCE END DATE: 07/31/2020

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The CRIT-ICU Biomarker Panel for Stratification of Mortality Risk in ARDS Patients - PROJECT SUMMARY: Acute Respiratory Distress Syndrome (ARDS) is a devastatingly intense lung inflammatory disorder that annually afflicts more than 1 million individuals world-wide (200,000 cases/year in the U.S.) with an unacceptable mortality rate of 30-40%. Substantial clinical and biological heterogeneity within ARDS phenotypes has greatly impeded therapeutic developments to reduce mortality. All therapies currently employed in ARDS management are ge- neric. The critical care community suffers from a lack of tools that allow identification of ARDS sub-phenotypes and individuals most likely to benefit from novel therapies. Recently, the hyperinflammatory and low inflammatory ARDS sub-phenotypes were identified that markedly differ in natural histories, clinical and biological character- istics, biomarker profiles, responses to positive end-expiratory pressure, ventilator- and organ failure-free days and mortality. ARDS severity (PaO2/FiO2 ratio), the severity of renal or hepatic failure, or the extent of leukocy- tosis failed to distinguish the two phenotypes. As the mortality of the hyperinflammatory phenotype is 3-5 times greater than low inflammatory phenotype, this Phase I STTR will leverage substantial complementary expertise to: i) establish a novel panel of ARDS biomarkers (CRIT-ICU Panel) that stratifies subjects at risk for ARDS into high and low mortality sub-phenotypes; and ii) develop a quantitative platform to allow assessment of these validated biomarkers upon patient entry into the ER or ICU. Our preliminary biomarker data are strong and include 11 ARDS-relevant plasma biomarkers in >250 well-phenotyped ARDS subjects and 70 controls. The targeted biomarkers include cytokine-chemokines (IL-6, IL-8, IL-1b, IL-RA), dual-functioning cytozymes i.e. cy- tokine/intracellular enzymes (macrophage migration inhibitory factor, NAMPT), vascular injury markers (VEGF- A, S1PR3, angiopoietin 2), and the advanced glycosylation end product pathway (HMGB1, soluble RAGE). Spe- cific Aim #1 will apply standard biostatistical approaches as well as novel neural network artificial intelligence analysis of this existing dataset to identify an optimal plasma-derived CRIT-ICU Panel which predicts ICU mor- tality in patients with sepsis or trauma who are at risk for development of respiratory failure and ARDS. Specific Aim #2 will develop an optimized and highly standardized Predictive Platform for the CRIT-ICU biomarkers iden- tified to be used in the clinical care setting. Finally, Specific Aim #3 will conduct retrospective validation studies of the optimized CRIT-ICU Panel in biobanked samples from 2 large cohorts: an emergency room-ARDS cohort (PETAL Clinical Network, n=800) and a Spanish sepsis-ARDS cohort (n=200). We speculate that unique exper- tise within Aqualung Therapeutics Corp., PAI Life Sciences Inc., InBios International Inc. and the University of Arizona Health Sciences will drive future prospective validation of the CRIT-ICU Panel in patients at risk for ARDS (Phase II STTR) and lead to development of a true Point of Care test to accelerate clinical trial stratification strategies, and development of innovative ARDS therapeutics to reduce mortality in this devastating syndrome.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2019	AQUALUNG THERAPEUTICS CORP.	1790 EAST RIVER #205	TUCSON	AZ	85718	PIMA	USA	Lung Diseases Research	000	1	2/19/2021	NEW	-$225,000
2021	2019	AQUALUNG THERAPEUTICS CORP.	1790 EAST RIVER #205	TUCSON	AZ	85718	PIMA	USA	Lung Diseases Research	002	1	7/7/2021	NEW	$0
2021	2019	AQUALUNG THERAPEUTICS CORP.	1790 EAST RIVER #205	TUCSON	AZ	85718	PIMA	USA	Lung Diseases Research	001	1	5/12/2021	NEW	$225,000
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $225,000 )
2019	2019	AQUALUNG THERAPEUTICS CORP.	4425 N HACIENDA DEL SOL ROAD	TUCSON	AZ	85718	PIMA	USA	Lung Diseases Research	000	1	8/8/2019	NEW	$225,000
														Subtotal = $225,000

Grand Total All Awards = $225,000

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The CRIT-ICU Biomarker Panel for Stratification of Mortality Risk in ARDS Patients

Award Number: R41HL147769

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/15/2019

PERIOD OF PERFORMANCE END DATE: 07/31/2020

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