SBIR-STTR Award

Development of Novel Agents for the Treatment of Renal Fibrosis
Award last edited on: 3/2/2021

Sponsored Program
SBIR
Awarding Agency
NIH : NIDDK
Total Award Amount
$4,841,847
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Fabio C Tucci

Company Information

Epigen Biosciences Inc

10225 Barnes Canyon Road Suite A104
San Diego, CA 92121
   (858) 657-0918
   info@epigenbiosciences.com
   www.epigenbiosciences.com
Location: Single
Congr. District: 51
County: San Diego

Phase I

Contract Number: 1R43DK092005-01A1
Start Date: 3/1/2012    Completed: 8/28/2013
Phase I year
2012
Phase I Amount
$389,603
The ultimate goal of our project is to develop novel therapeutics effective in chronic kidney diseases that normally develop fibrosis, lead to end stage renal disease and require renal replacement therapy. This will be achieved by identifying novel selective functional antagonists for the lysophosphatidic acid (LPA) type 1 receptor. Our drug discovery approach will synthesize novel compounds free of drug-drug interaction risks that demonstrate selective, functional antagonism of the LPA-1 receptor. Their effectiveness will be confirmed using a series of high throughput cell-based assays. Candidate molecules will then be evaluated for their ability to prevent the progression of renal fibrosis in a unilateral ureteral obstruction (UUO) animal model. The intent of this Phase 1 study is to identify at least one novel series of molecules for lead optimization in a Phase 2 program.

Public Health Relevance:
The objective is to discover and develop new drugs for treating chronic kidney diseases that involve renal fibrosis, a significant cause of mortality.

Phase II

Contract Number: 2R44DK092005-02A1
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
2014
(last award dollars: 2020)
Phase II Amount
$4,452,244

The ultimate goal of our project is to develop novel therapeutics effective in chronic kidney diseases that normally develop fibrosis, lead to end stage renal disease and require renal replacement therapy. This SBIR phase 2 application builds on the results obtained in phase 1 where novel and selective small molecule antagonists were discovered that prevent the progression of renal fibrosis in a unilateral ureteral obstruction(UUO) animal model. Leads identified in phase 1 will be optimized for drug-like and ADME properties. Candidate compounds meeting the selection criteria will be assessed for safety in vivo and the best compound will be examined in several different animal models of chronic kidney disease to delineate a development path in the clinical setting.

Thesaurus Terms:
Achievement;Acute;Analog;Animal Model;Area;Back;Behavior;Biological Assay;Caco-2 Cells;Canis Familiaris;Cell Model;Characteristics;Chronic Kidney Failure;Clinical;Clinical Efficacy;Commercialization;Cyp2d6 Gene;Cyp3a4 Gene;Development;Diabetic Nephropathy;Disease Model;Dose;Drug Kinetics;End Stage Renal Failure;Evaluation;Feasibility Studies;Fibrosis;Goals;Grant;Human;Improved;In Vitro;In Vivo;Inhibitory Concentration 50;Kidney;Lead;Lead Series;Letters;Lipophilicity;Liver Microsomes;Lysophosphatidic Acid Receptors;Medical;Meetings;Metabolic;Modeling;Mortality Vital Statistics;Mus;Novel;Novel Therapeutics;Oral Administration;Permeability;Pharmaceutical Preparations;Pharmacotherapy;Phase;Positioning Attribute;Pre-Clinical;Preclinical Study;Preparation;Prevent;Programs;Property;Public Health Relevance;Rattus;Renal Replacement Therapy;Research;Safety;Safety Study;Scale Up;Selection Criteria;Series;Signal Pathway;Small Business Innovation Research Grant;Small Molecule;Standard Of Care;Streptozocin;Testing;Therapeutic Intervention;Therapy Development;Toxic Effect;Ureteral Obstruction;