Metabolic Solutions Announces Preliminary Results From Phase IIa Clinical Trial

Metabolic Solutions Development Company (MSDC) announced that its lead compound, MSDC-0160, can improve insulin sensitivity and lower blood glucose levels in humans without the side effects of current therapies when taken over a 28-day period, according to preliminary data derived from the company’s Phase IIa clinical trial.

“This preliminary data confirms that a PPAR-sparing thiazolidinedione (TZD) can improve insulin sensitivity and lower glucose similar to a traditional TZD,” said Dr. Jerry Colca, president and chief scientific officer of MSDC. “These results are contrary to the commonly accepted theory of how leading diabetes drugs work and support our theory surrounding PPAR-sparing TZDs that led us to develop this lead compound and our drug portfolio. These results further validate our ongoing development efforts with follow-on compounds.” The company plans to file an Investigational New Drug Application for a second-generation compound by the end of 2009.

Nearly 100 patients participated in this double blind, placebo and active controlled multicenter clinical trial conducted in the United States. This Phase IIa clinical trial follows two successful Phase I trials that validated earlier indications of an improved pharmacokinetic and safety profile of MSDC-0160.

Similar to Actos, MSDC-0160 lowered the circulation of fatty acids and significantly increased good (HDL) cholesterol. Unlike Actos, MSDC-0160 did not decrease the levels of circulating blood cells and did not produce an increase in body weight.

Complications from the leading type 2 diabetic therapies include weight gain and edema as well as the potential for congestive heart failure and bone loss.

“Our drug development program focuses on a different molecular target,” said Colca. “We believe that selective activation of the novel mitochondrial target will produce a significantly improved safety profile for individuals with type 2 diabetes. If the results of this study can be successfully extended to longer trials, we might be able to achieve our long-term goal of a therapeutic option that could be used early in the course of the disease to prevent the otherwise inexorable progression of diabetes and its complications.”

Colca and Rolf Kletzien, two West Michigan scientists who are developing the MSDC drug portfolio of more than 100 analogs, have spent much of their careers working on treatments for type 2 diabetes. Colca also was instrumental in the early development of pioglitazone (the active ingredient in Actos) during his tenure with Upjohn Company.

“We are pleased that our lead compound performed so well in the Phase IIa study," said Mark Olesnavage, chief executive officer of MSDC. “The preliminary Phase IIa results match our pre-clinical studies that suggested that this compound can deliver significant metabolic benefit without some of the complications inherent in current therapies.”

Additional safety and expanded efficacy data will be gathered in a 90-day, multinational Phase IIb study that is planned for late 2009.

According to the American Diabetes Association, approximately $1 in every 10 health care dollars spent is attributed to diabetes. While an estimated 17.9 million Americans have been diagnosed with diabetes, 6.3 million people (or nearly one in four) are unaware that they have the disease.

There were 1.6 million new cases of diabetes in the United States during 2007. This growth rate of 7 percent continues to outpace the population growth and has been described by many health care professionals as an epidemic.