USA flag logo/image

An Official Website of the United States Government

Phase I Clinical Study Using an Antifibrotic Drug

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
96035
Program Year/Program:
2010 / SBIR
Agency Tracking Number:
DK085781
Solicitation Year:
N/A
Solicitation Topic Code:
NIDDK
Solicitation Number:
N/A
Small Business Information
ANGION BIOMEDICA CORPORATION
51 Charles Lindbergh Blvd Uniondale, NY -
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2010
Title: Phase I Clinical Study Using an Antifibrotic Drug
Agency: HHS
Contract: 1R44DK085781-01
Award Amount: $311,292.00
 

Abstract:

DESCRIPTION (provided by applicant): Liver fibrosis, a disease affecting tens of millions of people worldwide, is the liver scarring response to chronic injury from excessive alcohol use, virus infection (hepatitis B and C), iron overload or extrahepatic o bstructions and can progress to liver cirrhosis, liver failure and death. In fact, deaths from complications of liver fibrosis/cirrhosis are expected to triple over the next decade as a result of the hepatitis C epidemic and the growing incidence of liver disease associated with non-alcoholic steatohepatitis. Currently available therapies, including antivirals, are largely ineffective in treating the underlying fibrosis, and in the majority of cases, liver transplantation is the only effective cure. Hepatic growth factor (HGF), also known as scatter factor (SF), has been shown to be efficacious in reducing liver fibrosis. The feasibility of HGF as gene or protein therapy however is limited by issues relating to immune and inflammatory responses evoked by ade noviral proteins, inherent instability of proteins in solution, their limited tissue half-life, and the exorbitant costs associated with such therapy. Supported by the National Institutes of Health (NIH) Small Business Innovative Research (SBIR) and Rapid Access to Interventional Development (RAID) programs, we have identified and developed BB3, a novel small molecule HGF mimetic. BB3 duplicates the bioactivities of HGF in every assay tested to date. Particularly, BB3 possesses cell protective, anti-fibroti c, and regenerative activities and shows efficacy in reducing liver fibrosis. The overall objective of our program is to advance BB3 to the clinic as a first-in-class antifibrotic for liver fibrosis. From a clinical perspective, a Phase I safety and pharma cokinetic (PK) trial of intravenously administered BB3 has been completed successfully in healthy volunteers and BB3 was found to be well tolerated. In addition, a clinical study of intravenously administered BB3 for safety and PK in renal dialysis patient s has been completed. While intravenous BB3 is being developed for acute indications, we are also developing oral BB3 for chronic indications. In this fast-track SBIR grant application, we propose to conduct a Phase 1 clinical study evaluating safety and P K of BB3 administered orally in healthy volunteers. PUBLIC HEALTH RELEVANCE: A small-molecule, hepatically protective and anti-fibrotic agent has significant clinical potential against both liver fibrosis.

Principal Investigator:

Weizhong Cai
5165621140
WCAI@ANGION.COM

Business Contact:

Itxhak D. Goldberg
igoldberg@angion.com
Small Business Information at Submission:

ANGION BIOMEDICA CORPORATION
ANGION BIOMEDICA CORP 1050 Stewart Ave. GARDEN CITY, NY 11530

EIN/Tax ID: 111343007
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No