Development of DT-110 as an oral therapeutic for type 2 diabetes

DESCRIPTION provided by applicant Type diabetes is a chronic debilitating disease that threatens to reach pandemic level by Nearly million people worldwide are currently affected by diabetes and more than of patients with type diabetes die of cardiovascular causes However no particular diabetes medication to date is considered superior in the minimization of the risk of cardiovascular diseases associated with type diabetes Therefore development of new anti diabetic drugs that also decreases the risk of cardiovascular diseases will be highly desirable and needed The product being developed is DT a tripeptide as an oral therapeutic for treatment of type diabetes Technological innovation is the application of tripeptide as an oral dosage form to treat human diseases In our phase I study we found that DT activates G protein coupled receptor D MrgprD signaling pathway that has not been reported to be linked to metabolic diseases Since activation of MrgprD has been shown to play a protective role in cardiovascular system our results suggest that DT may have beneficial effects on cardiovascular system in addition to controlling blood glucose levels and therefore potentially be a first anti diabetic drug that can minimize the risk of cardiovascular diseases associated with type diabetes The long term goal of this SBIR is to complete the preclinical study on DT file IND and commercialize it as a new class of anti type diabetes drugs capable of reducing the risk of cardiovascular diseases associated with type diabetes The mechanism of action of DT is different from that of the currently available medications for type diabetes In the Phase II study we will test the hypothesis that DT specifically acts on this novel signaling pathway to effectively lower the blood glucose levels and protecting cardiovascular system in the patients with type diabetes Specific aims of this Phase II SBIR are to examine the therapeutic roles of DT in controlling glucose levels and in regulation of blood vessel vasodilation in the genetically modified mice to develop an enteric coated DT and to determine the blood glucose lowering effect of DT in a large animal model This study will provide significant information for our understanding of novel mechanism of action of DT and its efficacy in various animal models to support IND filing and ultimately lead to successful development of a new drug for treatment of type diabetes which may also has a protective effect on cardiovascular system PUBLIC HEALTH RELEVANCE In this Phase II SBIR Diapin Therapeutics plans to develop DT as an oral anti type diabetes drug that potentially decreases the risk of cardiovascular diseases associated with type diabetes a metabolic disease that currently affects about million people In USA No particular diabetes medication to date is considered superior in the minimization of the risk of cardiovascular diseases and any new drugs for treatment of type diabetes that concurrently decrease the risk of cardiovascular diseases will be much needed The goal of this SBIR project is to complete the pre clinical development and open clinical trials leading to commercialization of DT as a novel therapeutic for treatment of type diabetes