KineMed Evaluates The Mechanism Of Action For Colesevelam In Patients With Type 2 Diabetes

Main Category: Diabetes
Also Included In: Clinical Trials / Drug Trials
Article Date: 22 May 2007 - 0:00 PST

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KineMed, Inc., a pathway-based drug discovery and development company, announced today that the company has received a grant from Daiichi Sankyo, Inc. to study the activity of colesevelam HCl, a bile acid sequestrant, in patients with type 2 diabetes. KineMed will apply its proprietary translational medicine technology, KineMarker(TM), to measure the effects of colesevelam HCl on multiple metabolic pathways in patients with type 2 diabetes.

Published studies (1-4) have reported that colesevelam HCl can reduce the levels of hemoglobin A1C and fasting plasma glucose in subjects with type 2 diabetes. Based upon these study results, Daiichi Sankyo, Inc. announced in January 2007 the filing of a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) seeking a new indication for colesevelam HCl to improve glycemic control in patients with type 2 diabetes mellitus.

In a recently initiated multi-center, investigator-sponsored clinical study, KineMed's technology will simultaneously measure the effects of colesevelam HCl in patients with type 2 diabetes on hepatic insulin sensitivity, gluconeogenesis, glucose absorption and lipid synthesis. A separate study will measure bile acid kinetics in healthy volunteers and subjects with type 2 diabetes.

KineMed's KineMarker technology is designed to quickly demonstrate, preclinically and clinically, whether compounds are "on mechanism" or are acting upon specific metabolic pathways that are the basis for particular diseases. KineMed's technology measures the kinetics of these pathways using a stable isotope labeling technique and mass isotopomer distribution analysis (MIDA), allowing observation of treatment-induced changes in patients.

David Fineman, President and CEO of KineMed, commented, "This investigator-initiated clinical study calls for KineMed to rapidly identify new uses for yet another late-stage or commercialized product by demonstrating on-mechanism therapeutic effect and dose-response in clinical studies. Direct application of our technology in this clinical setting further demonstrates the importance of insightful translational medicine in contemporary drug development."

About KineMed, Inc.

KineMed, Inc. ("KineMed" or the "Company") is a drug discovery and development company employing its proprietary translational medicine technology (AquaTag(TM) and KineMarker(TM)) to both identify active drug candidates preclinically and confirm their therapeutic activity and dose response in first-in-man studies. KineMed's technology expedites the drug development process and provides real-time insight into conditions including metabolic disorders, cancer, and diseases of inflammation and neurodegeneration.

KineMed is working to develop drugs both on its own and with pharmaceutical collaborators in therapeutic focus areas where it can demonstrate functional modulation of specific biological pathways that mediate disease. The Company has multiple development programs with more than a dozen major pharmaceutical companies, including Bayer, Merck, Organon and Roche.

For further information about KineMed, please visit: http://www.kinemed.com

References:

1. Zieve FJ, Kalin MF, Schwartz SL, Jones MR, Bailey WL. Results of the Glucose-Lowering Effect of WelChol Study (GLOWS): A randomized, double-blind, placebo-controlled pilot study evaluating the effect of colesevelam hydrochloride on glycemic control in subjects with type 2 diabetes. Clinical Therapeutics; 2007 Jan;29(1):74-83.

2. Goldberg R., Truitt K. Colesevelam HCl improves glycemic control in type 2 diabetes mellitus subjects managed with insulin therapy. American Heart Association Annual Meeting. Chicago, Illinois. November 2006.

3. Bays HE., Goldberg RB, Truitt K, et al. Addition of colesevelam HCl to patients with type 2 diabetes mellitus inadequately controlled on metformin-based therapy improves glycemic control. American Association of Clinical Endocrinologists 16th Annual Meeting and Clinical Congress. Seattle, Washington. April 2007.

4. Fonseca B, Rosenstock R, Truitt K, et al. Colesevelam HCl added to sulfonylurea-based therapy in patients with inadequately controlled type 2 diabetes mellitus improves glycemic control. American Association of Clinical Endocrinologists 16th Annual Meeting and Clinical Congress.

KineMed, Inc.
http://www.kinemed.com