Metabolic gets good results on obesity drug

Metabolic Pharmaceuticals (ASX: MBP) has achieved another milestone in its development of a weight-loss drug after demonstrating that its obesity drug AOD 9604 is active after oral administration to human patients.

Managing director Chris Belyea called the Phase IIA trial result a landmark, noting that oral administration was the optimal method of delivery.

The peptide drug, based on a region of human growth hormone, was administered as a single dose to 16 clinically obese but otherwise healthy men aged 35-60 in a double-blinded study. Previous studies had delivered the drug by injection, but animal studies had demonstrated that oral administration was possible.

The drug significantly increased the breakdown of fat for several hours after administration compared to patients receiving a placebo. One week after dosing, the patients who received the drug had lost an average of 0.2 kg.

"We can now proceed without further delay to proof-of-concept next year," said Belyea.

He explained that a short term daily dose study was being planned to begin in October, with results expected at the end of the year. In this study, patients would be dosed every day for a week to check for adverse effects.

"We've seen nothing so far in terms of adverse effects," Belyea said.

Following this study, Metabolic plans to do a larger scale Phase IIB trial in 150 patients to establish weight loss after extended dosing and to determine the optimal dosing range.

Belyea said the company was currently making a decision on the length of the trial, among other details. The trial is expected to begin in 2003.

"If all continues to go well, we hope to bring the drug to market in 2006," he said.

Metabolic's drug was developed by Monash University researcher Dr Frank Ng. So far Metabolic has spent $15 million developing the drug, which has a potential market size in excess of $US10 billion.

At the time of writing Metabolic's share price had dropped nearly 8 per cent to 88 cents.