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Novel treatment for Crohn's disease and related inflammatory gastrointestinal disease

Award Number: R43DK098847
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: 05/01/2016
PERIOD OF PERFORMANCE END DATE: 04/30/2017

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Novel treatment for Crohn's disease and related inflammatory gastrointestinal disease - ¿ DESCRIPTION (provided by applicant): Crohn's disease is an inflammatory disorder of the gastrointestinal (GI) tract, likely associated with a hyperactive immune response to commensal bacteria and mucosal damage. The treatments for Crohn's disease and inflammatory bowel diseases (IBDs) in general have the potential for serious side effects. New approaches for controlling the progression of these diseases are needed. A treatment that works at the mucosal surface, to modulate mucosal inflammation and associated GI damage to prevent or reduce disease severity, would change the quality of life for millions worldwide. A recently developed polysaccharide derivative (PAAG) acts at the mucosal surfaces to facilitate a reduction of inflammation and enhanced barrier function by reducing GI damage. Understanding how PAAG directly modulates key mediators in innate host defense and mucosal integrity, such as toll-like receptors (TLR's) and similar pathways is essential in providing a well-tolerated treatment alternative. In vitro cell based assays will assess the influence of PAAG on TLR activation by pathogen associated molecular patterns (PAMP's) and damage associated molecular patterns (DAMP's) in human GI cells via colorometric signal transduction reporter-gene based assays and pathways, focused qPCR analysis. The effectiveness of oral PAAG treatment in the adoptive transfer model of chronic colitis in vivo will be assessed and compared to confirm prior study success in acute GI inflammatory animal models. Genes influencing the therapeutic response of PAAG in the mouse colon, compared to vehicle control will be identified following hypotheses driven gene expression analysis guided by prior gene expression analysis in related models of GI inflammation. Fecal and serum markers, indicative of the level of GI damage and inflammation, will be measured via ELISA and further validate the effectiveness of PAAG treatment. Molecular methods will determine if microbiome diversity is influenced by treatment with PAAG. The goal of this study is to optimize PAAG dosage and elucidate specific mechanisms that facilitate efficacious disease treatment. Successful outcomes will guide further development of this product toward clinical trials of a safe and effective treatment for Crohn's disease and related IBD's.


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: 2017 ( Subtotal = $0 )
2017	2016	SYNEDGEN, INC.	1420 N CLAREMONT BLVD STE 105D	CLAREMONT	CA	91711	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	8/14/2017	NEW	$0
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $224,412 )
2016	2016	SYNEDGEN, INC	1420 N Claremont Blvd 105d	Claremont	CA	91711	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	4/19/2016	NEW	$224,412
														Subtotal = $224,412

Grand Total All Awards = $224,412

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Novel treatment for Crohn's disease and related inflammatory gastrointestinal disease

Award Number: R43DK098847

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: 05/01/2016

PERIOD OF PERFORMANCE END DATE: 04/30/2017

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