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A NOVEL THERAPEUTIC FOR LIVER FIBROSIS

Award Number: R44AA020163
ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 12/01/2010
PERIOD OF PERFORMANCE END DATE: 08/31/2014

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A NOVEL THERAPEUTIC FOR LIVER FIBROSIS - DESCRIPTION (provided by applicant): Alcoholic and non-alcoholic liver fibrosis remains an unsolved challenge for the hepatologist as it can lead to cirrhosis and end-stage liver disease, a life-threatening condition that necessitates liver transplantation. Current therapeutic strategies for the treatment of liver fibrosis include changes in diet, life-style and/or medications to allevate the underlying cause of disease. Since liver disease is typically diagnosed following significant scar formation, adjuvant strategies that oppose the molecular and cellular program of fibrosis that drives liver disease and activate matrix degrading pathways are urgently required. A preponderance of preclinical data in models of fibrotic liver disease speaks to collagen catabolizing activity of endogenous peptide hormone Relaxin (H2R). Translation of these findings into clinical regimen has been painfully slow in large part due to the costs and logistica difficulties associated with commercial production of recombinant human (rh) H2R. Using molecular modeling-and medicinal chemistry-based drug design, Angion Biomedica has developed a library of single chain, short length H2R-like peptides that can be chemically synthesized and potentially offer multiple clinico-commercial advantages over rhH2R therapy. SBIR Phase I studies have identified a lead antifibrotic candidate, ANG-4011, from within this library, that has excellent drug-like properties and is therapeutic in multiple preclinical models f renal and hepatic fibrosis, opposing matrix deposition in kidney and liver. In partnership with the internationally recognized laboratory of Prof. Kathryn Uhrich (Rutgers University, NJ), and representing a landmark step in sustained in vivo delivery of peptides, we have developed a clinically compatible, biodegradable, microsphere-based extended release formulation for ANG-4011. The proposed milestone-driven SBIR Phase II study is designed to make a comprehensive evaluation of our lead candidate in preclinical models of liver fibrosis while optimizing its delivery. Data from this SBIR Phase II program will allow for entry of this lead candidate to the preclinical safety/toxicology battery to be completed under the aegis of the SBIR Phase IIb competing renewal mechanism. The ultimate objective of this program is to bring an H2R-like antifibrotic to clinical trials for treatment of liver 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: 2013 ( Subtotal = $1,038,130 )
2013	2013	ANGION BIOMEDICA CORPORATION	350 COMMUNITY DRIVE	MANHASSET	NY	11030	NASSAU	USA	Alcohol Research Programs	000	3	8/19/2013	NON-COMPETING CONTINUATION	$1,038,130
														Subtotal = $1,038,130

Issue Date FY: 2012 ( Subtotal = $971,501 )
2012	2012	ANGION BIOMEDICA CORPORATION	350 COMMUNITY DRIVE	MANHASSET	NY	11030	NASSAU	USA	Alcohol Research Programs	000	2	9/18/2012	COMPETING CONTINUATION	$971,501
														Subtotal = $971,501

Grand Total All Awards = $2,009,631

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A NOVEL THERAPEUTIC FOR LIVER FIBROSIS

Award Number: R44AA020163

ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 12/01/2010

PERIOD OF PERFORMANCE END DATE: 08/31/2014

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