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Biologic Inhibitor of Galectin-3 for Liver Fibrosis

Award Number: R43DK107285
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/20/2018
PERIOD OF PERFORMANCE END DATE: 08/31/2021

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Biologic Inhibitor of Galectin-3 for Liver Fibrosis - PROJECT SUMMARY/ABSTRACT Chronic liver disease affects approximately 3 million people in the United States and leads to more than 42,000 deaths each year. The overall goal of this project is to develop a protein biologic (MM-003) that acts by inhibition of galectin-3 as a therapy for prevention and treatment of chronic liver fibrosis. Fibrosis is the outcome of almost all chronic liver diseases. It is due to a dynamic scarring process caused by the response of the body to liver injury in a similar way that injury causes scarring in the skin or other organs through the deposition of collagen and other extracellular matrix (ECM) components. Fibrosis that is so extensive that the liver is no longer functional results in cirrhosis – the main cause of death from chronic liver disease. Resolution of liver fibrosis has been shown in animal models and in patients after treatment and/or removal of a causative agent but there are no approved agents that act to prevent or reverse fibrosis. Mounting data implicate galectin-3 as a causal factor in liver fibrosis. Compared to wild type mice, galectin-3 deficient mice were protected from liver fibrosis from carbon tetrachloride exposure or bile duct ligation (BDL) despite equivalent injury. Inhibition of galectin-3 expression with small interfering (si) RNA had a therapeutic effect in the carbon tetrachloride mouse model of acute liver disease. In the BDL mouse model of chronic liver disease, galectin-3 expression was induced in hepatic stellate cells (HSCs) that give rise to the fibrogenic myofibroblasts. Systemic and hepatic vein levels of galectin-3 were increased in patients with alcoholic liver cirrhosis and the levels were negatively correlated with liver function. We postulate that inhibition of galectin-3 by MM-003 will have a preventative effect on the development of liver fibrosis, will be therapeutic for chronic liver disease, and will be safe for chronic use. The overall goal in Phase I is to obtain evidence of the potential efficacy of MM-003, a biologic inhibitor of galectin-3, for therapy of chronic liver fibrosis. There are two Specific Aims for Phase I: Aim 1. Determine the effect of MM-003 on profibrotic activity of primary human hepatic stellate cells and macrophages in vitro. Aim 2. Determine the anti-fibrotic potential of MM-003 in mouse models of liver fibrosis. 2A. Determine efficacy in preventing and treating liver fibrosis in a mouse bile duct-ligation (BDL) model of fibrosis. 2B. Determine efficacy in preventing, treating, and reversing liver fibrosis in a mouse carbon tetrachloride (CCl4) model of fibrosis.


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: 2022 ( Subtotal = -$1 )
2022	2018	MANDALMED INC	665 3RD ST	SAN FRANCISCO	CA	94107	SAN FRANCISCO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	2/15/2022	NEW	-$1
														Subtotal = -$1

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2018	MANDALMED INC	665 3RD ST STE 250	SAN FRANCISCO	CA	94107	SAN FRANCISCO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	8/19/2020	NEW	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2018	MANDALMED INC	665 3RD ST STE 250	SAN FRANCISCO	CA	94107	SAN FRANCISCO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	1/10/2019	NEW	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $299,900 )
2018	2018	MANDALMED INC	665 3RD ST STE 250	SAN FRANCISCO	CA	94107	SAN FRANCISCO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/20/2018	NEW	$299,900
														Subtotal = $299,900

Grand Total All Awards = $299,899

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Biologic Inhibitor of Galectin-3 for Liver Fibrosis

Award Number: R43DK107285

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/20/2018

PERIOD OF PERFORMANCE END DATE: 08/31/2021

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