Half a kilo a week -- early results for Australian obesity drug
Half a kilo a week -- early results for Australian obesity drug
MELBOURNE, AUSTRALIA, March 2, 2003 -- Trial results announced today confirm that the Australian-invented obesity drug AOD9604 is safe, says the developer, Metabolic Pharmaceuticals Ltd.
Participants in the one week long phase 2A trial also lost an average of half a kilo. The next step will be a three-month weight loss trial with at least 250 participants -- scheduled to start mid-year.
"We're excited by the results," said Chris Belyea, CEO of Metabolic Pharmaceuticals. "It's the latest in a long series of positive trial results."
The drug enhances a natural hormonal process in the body that helps control fat metabolism, and is based on discoveries made by Dr Frank Ng and his colleagues at Australia's Monash University.
"It's a completely different approach from that of our global competitors, unique in that it replicates the natural fat reducing properties of growth hormone," said Chris Belyea.
Human growth hormone acts as a "fat controller", moderating fat metabolism. The decline of human growth hormone levels as we age is one of the factors responsible for middle age spread.
But human growth hormone has many other roles in the body, such as bone growth. AOD9604 mimics the natural fat reducing properties of human growth hormone without producing any effects on blood sugar control or growth. "Our drug is based on a part of the natural human growth hormone protein so after each dose it will go into the body, send out a molecular signal, naturally enhance fat metabolism and then quickly disappear."
"Because we are using a natural chemical structure that mimics the body's natural mechanism, we don't expect this drug to cause the side-effects that have plagued previous weight-control drugs on the market," Dr Chris Belyea said. "If a weight loss of about 0.5 kg per week and the excellent safety profile is confirmed over longer term dosing, AOD9604 will be substantially more effective than existing obesity drugs.
The trial was a randomised, double-blind, placebo-controlled Phase 2A dose escalation study to assess the safety of oral daily dosing of AOD9604 in 36 obese male volunteers. The study was designed with the primary end-point of safety in mind.
The key findings from the study were:
- a positive outcome on safety and tolerability;
- weight loss trends met expectations and occurred in exactly the pattern predicted from earlier studies;
- the optimum effective daily dose may be 10 mg or possibly lower;
- in the 10 mg dose group, the overall weight loss was 1.0 kg compared to 0.4 kg in the placebo group, and in the 20 older volunteers the weight loss was 0.8 kg compared to a weight gain of 0.1 kg in the placebo group.
The trial was conducted at the Royal Adelaide Hospital, South Australia.
Source: Metabolic Pharmaceuticals Ltd www.metabolic.com.au
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