Type II diabetes (T2DM) affects more than 5% of the population in Western countries. In the US alone, about 23.6M children and adults have diabetes, and the associated cost was estimated to $174 billion in 2007. The rise in T2DM prevalence is linked to the dramatically increased incidence of obesity, which now affects about a third of the adult US population. Historically, T2DM was only seen in adults, but it is increasin steadily in children where the obesity rate is approaching 17% (2-19 year- old). Insulin resistance and beta-cell dysfunction are key components of the T2DM pathology. Without intervention to reduce insulin resistance and the associated loss of beta-cell mass, T2DM patients can develop a need for insulin therapy similar to type I diabetes patients. Although a range of therapeutics exist for improving insulin resistance and glucose tolerance in T2DM patients, the cost and outcomes for this patient population show there is a dire need for novel therapeutics that target the inflammation that leads to insulin resistance and beta-cell dysfunction in T2DM. This proposal will test if SP16, a new, anti-inflammatory, therapeutic peptide, can be administered orally or by subcutaneous injection, to provide protection against insulin resistance and beta-cell dysfunction in db/db mice. SP16 is a 17 amino acid peptide and our preliminary data show that it improves glucose tolerance and beta-cell function in db/db mice, when administered by intraperitoneal injection. Identifying a practical route of administration is a prerequisite to initiating a formal preclinical development program, working towards submission of an IND application. We anticipate the proposed studies will enable a GLP safety/tox program as well as submission of a follow-on Phase II SBIR application to support this.

Public Health Relevance

The aim of this project is to test a new, therapeutic peptide drug for treatment of type II diabetes. Although a range of therapeutics exist for treatment of type II diabetes patients, the cost and outcomes for this patient population show there is a dire need for novel therapeutics that target the underlying pathologies of the disease. This new peptide drug has tremendous potential for improving patient quality of life and reducing health care costs.

Agency
National Institute of Health (NIH)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43DK101203-01
Application #
8646233
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Arreaza-Rubin, Guillermo
Project Start
Project End
Budget Start
Budget End
Support Year
1
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Serpin Pharma, LLC
Department
Type
DUNS #
City
Nokesville
State
VA
Country
United States
Zip Code
20181