If you don't manage to keep the fat off, there is still hope. MBP Metabolic Pharmaceuticals has just completed phase 2a oral human trials of its anti-obesity drug AOD9604 and the results is out next month. Heres a excerpt from MBP's website.
What is AOD9604?
AOD9604 is a new experimental obesity drug discovered by Prof Frank Ng at Monash University, being developed through clinical trials by Melbourne-based biotechnology company Metabolic Pharmaceuticals Ltd www.metabolic.com.au (ASX: MBP).
How does it work?
The drug mimics one of the actions of a natural hormone which is always present in the body, called Growth Hormone. Growth Hormone (as its name suggests) helps cause us to grow up when we are young, but it also is what helps us to stay thin when we are young by making our fat cells store less fat and and by making them burn more of the fat which is already stored. Growth hormone gradually becomes less active as we pass into middle age, and is a strong factor in why we get fatter as we get older. AOD9604 mimics only the slimming effects of growth hormone, and not its growth effects. AOD works by stimulating metabolism in animal models of obesity. It increases the breakdown of fat (lipolysis) and decreases the accumulation of fat in tissues (lipogenesis). The exact mechanism of this stimulation and inhibition is currently under investigation. AOD has not shown any signs of influencing appetite. Further information can be obtained at the following links:
AOD9604 Publications
Who will most benefit?
As the drug works to reverse the age-associated increase in obesity, it is likely that people aged 30+ who have become fatter gradually with age will benefit the most.
Does the drug have any side effects?
So far no side effects have been found in approximately 40 patients who have been administered the drug, and the company believes that a very favourable side effect profile is likely in comparison to the existing drugs on the market, which mostly act on the brain to affect appetite and have many side effects.
How long will it take to come on the market?
The drug has just finished the first small-scale single-dose studies in obese patients, and there are many more extensive long-term weight reduction trials to be finished before it can be approved and be proven to work and be safe long-term. This process will take at least 4 years from now.
What did the recent clinical trial show?
The recent trial was on 22 obese male patients of varying ages who were dosed intravenously with single doses of AOD9604 or placebo. What was found was that for those patients aged over 35, the drug caused the expected increase in fat breakdown and also caused significant weight loss compared to placebo in the week following the injection. At the highest dose the average weight loss was 0.5 kg in 1 week.
How will the drug be taken?
If the drug is shown to work orally, it will be taken as a once per day capsule.
How much weight will people lose long term?
The company believes that a continuing weight loss of about 0.5 kg per week after daily dosing is a reasonable assumption, which will tend to decrease as target weight is approached. The drug is unlikely to reduce the fat of non-obese patients.
Will you have to be on a diet while taking the drug?
These results are expected to be obtained while the patient is on a normal diet, but special diet and exercise programs will of course help accelerate the weight loss.
How much will it cost?
The drug will be a prescription drug and it is anticipated that the price will be in the rough vicinity of $5 per day.
Can I get into the human clinical trial? A. Patients will be selected for the next Phase of clinical trials by the trial center, depending on its location. However, you may email us basic details (name, email, country and postcode), and we can keep them on record and we may contact you when patients for the trial are needed. Title your email "AOD Trial Volunteers" and send it to [email protected].
When will AOD be on the market? A. The drug trial process is lengthy, given there are an enormous amount of strict guidelines which must be followed. All going well, we believe that AOD may be on the market in 4 years (2005). Based on previous experiences, Phase II generally takes 1 year, Phase III 2 years and the approval and marketing may take a further year.
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