Sep

8

Manhattan Pharmaceuticals Obesity Drug Safe in Phase Ia Study

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Manhattan Pharmaceuticals Obesity Drug Safe in Phase Ia Study
Prior Animal Studies Suggest This Experimental Drug Resets The Brain’s ‘Appetite Meter’

NEW YORK, Sept. 7, 2005 (PRIMEZONE) — Manhattan Pharmaceuticals, Inc. (OTCBB:MHTT) said Oleoyl-estrone, its experimental obesity drug, was shown to be safe with no serious adverse events noted in a Phase Ia study of 36 obese volunteers.

The results were announced this morning at the Oppenheimer & Co. Diabetes Conference at the Warwick Hotel during a presentation by Manhattan’s chief executive officer, Douglas Abel.

The dose-escalating study was conducted to measure the pharmacokinetic profile of Oleoyl-estrone (OE), as well as its safety and tolerability in obese males and females. Twelve of the 36 patients received placebo and 24 received a single dose of OE in one of six strengths ranging from 1mg to 150mg.

A follow-on study, a Phase Ib, will assess the drug’s safety and tolerability in 24 obese volunteers in four cohorts of six patients each receiving either placebo or OE in doses ranging from 10mg to 150mg for seven consecutive days. The company anticipates releasing additional data from these studies in the early Fall.

OE is an orally administered small molecule that lowers the appetite setting in the brain’s ponderostat, decreasing food intake without affecting energy expenditure. It has been shown to cause significant weight loss in extensive preclinical studies with lean and obese animals, even in the presence of abundant food and water.

Obesity is one of the most common metabolic disorders in the world. Nearly 61 percent of all Americans are considered to be overweight, and 26 percent are considered to be obese. The World Bank estimates that obesity alone accounts for more than 12 percent of the U.S. national health care budget. The National Institutes of Health estimated that direct costs for the treatment of obesity in 1988 were in excess of $45 billion and accounted for nearly ten percent of the total national cost of health care; a decade later, annual direct costs for the treatment of obesity had risen to $102 billion. As these statistics illustrate, obesity is a rapidly growing, costly disease for which there is currently no effective treatment. Moreover, diet and physical exercise regimens are difficult to maintain. As a result, most overweight patients can lose only moderate amounts of weight, and usually only for a short period of time. The current medications for the treatment of obesity have significant side effects that limit their use.

Manhattan believes that a safe, effective, orally administered compound that not only produces, but also sustains weight loss would be a breakthrough in the treatment of obesity, and would represent a significant advantage over currently available treatments. The company estimates that the future market opportunity is in the multi-billions of dollars range, given the number of individuals in the U.S. suffering from obesity and the rapid growth of the problem globally.


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