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Evaluation of SBP-101 for the Treatment of Acute Pancreatitis

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41DK111337-01
Agency Tracking Number: R41DK111337
Amount: $225,000.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 300
Solicitation Number: PA14-054
Timeline
Solicitation Year: 2014
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-09-21
Award End Date (Contract End Date): 2018-08-31
Small Business Information
15625 W HIGHWAY 318
Williston, FL 32696-4438
United States
DUNS: 019856037
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 MICHAEL WALKER
 (612) 804-6061
 mwalker@sunbiopharma.com
Business Contact
 MICHAEL CULLEN
Phone: (612) 940-6056
Email: mcullen@sunbiopharma.com
Research Institution
N/A
Abstract

Project Summary
Pancreatitis is a significant public health problem accounting for over $ Billion of health care costs
annually Approximately one third of patients with acute pancreatitis will go on to have recurrent pancreatitis
Of those about will progress to chronic pancreatitis a painful disease with an increased risk of both
diabetes and pancreatic cancer More than of people with just one episode of pancreatitis will develop
diabetes Currently treatment for pancreatitis is palliative as there is no specific treatment available
The pancreas has two parts the exocrine part where digestive enzymes are made and the endocrine
part where insulin is made Pancreatitis occurs when digestive enzymes are activated and released into the
pancreatic tissue rather than into the intestine In the tissue they initiate pancreatitis through their digestive
activity We have identified a new drug SBP which is relatively specific for the pancreas and has been
shown in pilot studies to decrease the severity of acute pancreatitis and the associated systemic inflammation
Our results suggest that administration of a single dose may be effective as a specific treatment for
pancreatitis
We will evaluate using in vivo models to test the hypothesis that treatment with SBP lessens the
injury caused by activated digestive enzymes in the tissue resulting in attenuation of pancreatitis Our
experiments are designed to determine the effects of SBP on the exocrine pancreas secretion of
enzymes into the blood stream systemic inflammation production of pro inflammatory cytokines and cell
viability The in vivo experiments are specifically designed to determine the effect of SBP in the setting of
both mild to moderate acute pancreatitis and severe acute pancreatitis
The body of work resulting from this project will serve as a proof of concept that SBP is a candidate
for clinical trials to test the efficacy of SBP in the treatment of pancreatitis Because there are no currently
available treatments a positive result from this project will have a considerable impact on the field Project Narrative
Pancreatitis is a significant public health problem accounting for over $ Billion of health care costs annually in
this country and more hospital admissions than any other gastrointestinal disease More than of patients
with just one episode of pancreatitis will develop diabetes and approximately one quarter will have
recurrences of those will develop chronic pancreatitis a very painful debilitating disease with no
effective treatment This project is designed to evaluate SBP for the treatment of pancreatitis and if
successful it would be the first drug ever to treat pancreatitis rather than its symptoms and sequelae

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

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