Type 2 diabetes is a chronic debilitating disease that threatens to reach pandemic level by 2030. Nearly 350 million people worldwide are currently affected by diabetes and more than 70% of patients with type 2 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 2 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-110, a tripeptide, as an oral therapeutic for treatment of type 2 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-110 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-110 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 2 diabetes. The long-term goal of this SBIR is to complete the preclinical study on DT-110, file IND, and commercialize it as a new class of anti-type 2 diabetes drugs capable of reducing the risk of cardiovascular diseases associated with type 2 diabetes. The mechanism of action of DT-110 is different from that of the currently available medications for type 2 diabetes. In the Phase II study, we will test the hypothesis that DT-110 specifically acts on this novel signaling pathway to effectively lower the blood glucose levels and protecting cardiovascular system in the patients with type 2 diabetes.
Specific aims of this Phase II SBIR are 1) to examine the therapeutic roles of DT-110 in controlling glucose levels and in regulation of blood vessel vasodilation in the genetically modified mice, 2) to develop an enteric coated DT-110, and 3) to determine the blood glucose lowering effect of DT-110 in a large animal model. This study will provide significant information for our understanding of novel mechanism of action of DT-110 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 2 diabetes, which may also has a protective effect on cardiovascular system.
In this Phase II SBIR, Diapin Therapeutics plans to develop DT-110 as an oral anti-type 2 diabetes drug that potentially decreases the risk of cardiovascular diseases associated with type 2 diabetes, a metabolic disease that currently affects about 29.1 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 2 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-110 as a novel therapeutic for treatment of type 2 diabetes.
