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Assessment of a selective kinase inhibitor in pre-clinical models of NASH

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43DK123920-01A1
Agency Tracking Number: R43DK123920
Amount: $375,033.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: 300
Solicitation Number: PA19-272
Timeline
Solicitation Year: 2019
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-09-01
Award End Date (Contract End Date): 2021-08-31
Small Business Information
10225 BARNES CANYON RD, STE A104
San Diego, CA 92121-2734
United States
DUNS: 963248807
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 FABIO TUCCI
 (619) 917-0639
 ftucci@epigenbiosciences.com
Business Contact
 FABIO TUCCI
Phone: (858) 657-0918
Email: ftucci@epigenbiosciences.com
Research Institution
N/A
Abstract

Summary
The ultimate goal of this application is to develop one of Epigen’s proprietary, selective and drug-like kinase
inhibitors for the effective treatment of liver fibrosis associated with chronic diseases such as non-alcoholic
steatohepatitis (NASH), a severe type of non-alcoholic fatty liver disease (NAFLD). NAFLD is the most common
liver disease and is associated with obesity and type-2 diabetes. There are no effective treatments available for
NASH. Our approach will involve the pre-clinical evaluation of one advanced lead compound, identified according
to a disease-specific progressive cutoff criteria, in two animal models of NASH to establish the proof-of-concept
in this indication. The successful outcome of this work will enable initiation of efforts to establish a more detailed
understanding of the pharmacology of the most promising candidate in rodent NASH models and
commencement of toxicology and chemistry, manufacturing and controls (CMC) work to support filing of an
investigational new drug (IND) application and eventually initiation of clinical trials in humans.Narrative
The objective is to develop new drugs for treating diseases that lead to liver fibrosis, including non-
alcoholic steato hepatitis (NASH), a significant cause of mortality.

* Information listed above is at the time of submission. *

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