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Development of DT-109 as an oral therapeutic for type 2 diabetes

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44DK104419-02
Agency Tracking Number: R43DK104419
Amount: $990,902.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: 200
Solicitation Number: PA14-071
Solicitation Year: 2015
Award Year: 2015
Award Start Date (Proposal Award Date): 2015-09-25
Award End Date (Contract End Date): 2015-09-24
Small Business Information
1600 HURON PKWY, B520, 2ND FL, Ann Arbor, MI, 48109-5001
DUNS: 062146468
HUBZone Owned: N
Woman Owned: Y
Socially and Economically Disadvantaged: N
Principal Investigator
 (212) 241-5651
Business Contact
Phone: (734) 764-9123
Research Institution
DESCRIPTION provided by applicant Type diabetes T D is chronic disease characterized by high blood glucose and rapidly emerged as a global health care problem that threatens to reach pandemic levels by Nearly million people worldwide are currently affected by diabetes Diabetes is a major cause of heart disease and stroke and also leads to other complications such as vision loss kidney failure and amputations of legs or feet The effective drugs for treatment of T D such as insulin and glucagon like peptide GLP require injections which are inconvenient and expensive Development of safer more effective and more convenient oral medicines therefore will be necessary for preventing the diabetes pandemic The product of this SBIR is the oral dosage form of DT for the treatment of T D DT is a tripeptide that effectively lowered blood glucose in several T D mouse models by increase the GLP and insulin levels when orally administered Since DT is comprised of natural occurring L amino acids it is considered to be a safer cheaper and a convenient pharmaceutical intervention for T D patients The long term goal of this SBIR is to complete preclinical development and identify a partner or investor consortium to fund clinical trials for DT as an oral therapeutic for T D Diapin Therapeutics has demonstrated that DT acts through a G protein coupled receptor GPCR to elicit its activity and high throughput screening of GPCR libraries showed the hits as an agonist among GPCRs This phase I hypothesis is that at least one of GPCRs are essential for DT to elicit its activity There are two specific aims in this phase I SBIR proposal Aim is to confirm the results from high throughput screening and identify the specific GPCR s required for the effect using a gain of function model Aim is to determine the functional importance of the GPCR s using a loss of function model Characterization of the MOA of DT is critical for our understanding of the pharmacology of DT The phase II of this SBIR will carry on the studies on pharmacokinetics toxicokinetics and complete the data set for opening IND for DT The patent for the oral dosage form of DT has been issued and the identification of DT targets will help us to bridge with big Pharmas to open clinical trials for DT as an oral therapeutic for T D PUBLIC HEALTH RELEVANCE In this Phase I SBIR Diapin Therapeutics plans to characterize the mechanism of action of DT for the development of DT as an oral therapeutic for type diabetes a metabolic disease that currently affects nearly million people worldwide Because the most effective drugs on the market require injections development of this new oral therapy is necessary for preventing diabetes pandemic The goal of this SBIR project is to complete the pre clinical development and open clinical trials leading t commercialization of DT as a novel therapeutic for type diabetes

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

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