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MetabolGut: a rapid assay platform to evaluate the impact drugs on lipid-handlingpathways and chylomicron-associated drug distribution using stem cell-drivenhuman absorptive enterocytes.

Award Number: R43TR004549
ORGANIZATION: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2023
PERIOD OF PERFORMANCE END DATE: 05/31/2025

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MetabolGut: a rapid assay platform to evaluate the impact drugs on lipid-handlingpathways and chylomicron-associated drug distribution using stem cell-drivenhuman absorptive enterocytes. - Project Summary Maintaining healthy physiology of the human gut is a large focus of Pharma. Models to study drug/nutrient absorption, xenobiotics, toxicology, and preclinical efficacies are hampered by the lack of accurate, reproducible, and easy to use cell culture models to evaluate such topics. For these reasons, there is a strong need for better in vitro models that recapitulate disease states of the human gut, and better platforms for drug discovery and validation. Lipid-handling is central to human health conditions and pharmacokinetics. Lipid-related metabolic disorders (i.e. obesity, insulin resistance, hyperlipidemia, and hypertension) are a global epidemic and predicted to increase as sedentary jobs and unhealthy diets increase. Treatments for metabolic disorders are sparse with limited efficacy highlighting the need for more broadly effective drugs. Lipid-handling mechanisms by Absorptive Enterocytes (AEs) can strongly influence oral drug Absorption, Distribution, Metabolism and Excretion (ADME), and drug bioavailability can be negatively and positively regulated by AE lipid-handing as many lipid soluble drugs are associated with chylomicrons (CMs). CM-associated-drug export by AEs is a first-line metric of bioavailability for lipophilic drugs with no accurate preclinical model. New tactics that harness lipid- handling mechanisms have strong potential to improve drug engineering for metabolic diseases, bioavailability and efficacy. To meet this need Altis Biosystems Inc., an early-stage biotechnology company, will collaborate with scientists at the University of North Carolina at Chapel Hill to develop Absorptive Enterocytes (AEs) on a high-throughput 96-Traswell format. ‘MetabolGut’ is a monolayer of differentiated AEs derived from the foundational technology, RepliGutTM, which is a stem cell-driven monolayer of human epithelium derived the small intestine or colon of organ donors and contains all of the proliferative and differentiated cell types found in vivo. The goal of this Phase I proposal is to develop four innovative elements: 1) rapid fluorescent readouts for lipid absorption and export, 2) simultaneous rapid detection of barrier integrity and fatty acid export, 3) rapid and highly sensitive identification of fatty acid metabolic species using non-radioisotope methods, 4) rapid fluorescent quantification of chylomicron (CM) export. While elements 1-3 have shown substantial utility for academic studies, they will be explored for commercial viability. Element 4 will be developed de novo as it represents a new assay for high-throughput detection of CM export and CM-associated drug quantification.


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: 2025 ( Subtotal = $0 )
2025	2023	ALTIS BIOSYSTEMS, INC.	6 DAVIS DR STE 159	DURHAM	NC	27713	DURHAM	USA	National Center for Advancing Translational Sciences	001	1	9/29/2025	NEW	$0
2025	2023	ALTIS BIOSYSTEMS, INC.	6 DAVIS DR	DURHAM	NC	27709	DURHAM	USA	National Center for Advancing Translational Sciences	000	1	10/23/2024	NEW	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	ALTIS BIOSYSTEMS, INC.	6 DAVIS DR	DURHAM	NC	27709	DURHAM	USA	National Center for Advancing Translational Sciences	000	1	8/9/2024	NEW	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $343,297 )
2023	2023	ALTIS BIOSYSTEMS, INC.	6 DAVIS DR	DURHAM	NC	27709	DURHAM	USA	National Center for Advancing Translational Sciences	000	1	8/14/2023	NEW	$343,297
														Subtotal = $343,297

Grand Total All Awards = $343,297

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MetabolGut: a rapid assay platform to evaluate the impact drugs on lipid-handlingpathways and chylomicron-associated drug distribution using stem cell-drivenhuman absorptive enterocytes.

Award Number: R43TR004549

ORGANIZATION: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/01/2023

PERIOD OF PERFORMANCE END DATE: 05/31/2025

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