Tuesday February 5, 2002

Press Release
SOURCE: Metabolic Pharmaceuticals Ltd.

Obesity Drug - Positive Results from Phase 2A Human Clinical Trial

MELBOURNE, Feb. 5 /PRNewswire/ -- An ``anti-fat'' drug with a significant worldwide market potential could be available in four years, after tests on obese men showed encouraging results, the Australian pharmaceutical research company developing the drug said today. Metabolic Pharmaceuticals Ltd, which is based in Melbourne, said its phase 2A human clinical trial of obesity drug AOD9604 had shown positive results in relation to safety and tolerability, fat breakdown and, of particular note, weight reduction after single intravenous doses.

Metabolic said the trials were conducted on clinically obese men, who received once a week for four weeks, one each of varying doses of AOD9604 and placebo. Although the trial was not designed to assess weight loss, the older men in the test group -- those over 35 years -- showed significant weight loss. ``It's very significant -- it is the first time we have tested it (AOD9604) in patients with an obese condition,'' Metabolic Pharmaceuticals Chris Belyea told AAP. ``Surprisingly, we were able to see weight reduction.'' The company said the aim of the trial was to assess safety and tolerability. ``There were no safety concerns and the drug was well tolerated at all doses,'' the company said. ``The overall data show an increase in fat breakdown two hours after AOD9604 dosing compared to the placebo.''

Mr Belyea said the next step was to conduct trials where the AOD9604 was taken orally. Oral trials were expected to start in April and results available a few months later. Ultimately, it was hoped that an oral ``anti-fat'' capsule would be developed that would first be made available by prescription and later over-the-counter. He said the drug could assist people suffering from obesity-related illnesses such as high blood pressure, high cholesterol, heart and kidney disease, and diabetes. The market was potentially worth $20 billion. ``Twenty per cent of people in the western world are obese,'' Mr Belyea said. He said Metabolic Pharmaceuticals could take AOD9604 forward by itself or appoint a major pharmaceutical company to market the drug at some point.

AOD9604 acts specifically on the body's fat cells to enhance the breakdown of stored fats and inhibits the synthesis of new fat. The biochemical result is similar to the slimming effects of exercise, according to the company. AOD9604 mimics the fat metabolic properties of human growth hormone (hGH). The level of hGH gradually declines with increasing age: hence older men tend to get fatter. Mr Belyea said treating obese people with hGH caused a gain in muscle, organ and bone mass and had other effects whereas AOD9604 did not.

SOURCE: Metabolic Pharmaceuticals Ltd.


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