Metabolic to look for big pharma partner after trial success

Metabolic Pharmaceuticals (ASX:MBP) is to look for a partnering opportunity with a major pharmaceutical company after it successfully completed its Phase IIb clinical trial on obesity drug AOD9604 showing the drug induced weight loss without side-effects.

The Australian-owned and developed drug was taken orally once daily for three months by 300 obese patients in the double-blinded, placebo controlled trial. Doses ranging from 1 milligram to 30 milligrams were administered to the trial participants, which included otherwise healthy men and women of non-childbearing potential aged 30-65 years. Patients in the trial had an average body mass index greater than 42 and average weight of 122 kilograms, and were provided with general diet and exercise advice, but not placed on any specific regime in addition to the drug.

Somewhat surprisingly, the lowest of the five doses administered in the trial appeared to be most effective, with an average weight loss of 2.8 kilograms over the 12-week period in the 1mg dose, compared to a weight loss of just 0.8 kilograms in the placebo group.

The results compare favourably with the market leading weight loss drugs Xenical and Meridia, but without the adverse effects associated with these drugs.

"The drug was remarkably well tolerated -- there were no observable side-effects," said Dr Boyd Strauss, head of the body composition laboratory and director of clinical nutrition and metabolism at Monash Medical Centre, and one of the principal investigators for the trial.

The rate of weight loss was also maintained during the trial, which CEO Chris Belyea said was an encouraging sign for longer-term studies. Typically, weight loss drugs work best in the initial three to six months of use, before effectiveness tapers off, he said. And one month after the completion of the dosing phase of the trial, there was no evidence of rebound weight gain in the patients receiving the drug.

Other factors considered during the trial included cholesterol profiles -- a small but consistent improvement was observed in patients taking AOD9604 -- and impaired glucose tolerance and diabetes -- a reduction in the number of patients with impaired glucose tolerance was observed in all of the groups except the placebo group.

Belyea said the drug was the first obesity drug to directly target fat metabolism. Most obesity drugs on the market act on appetite suppression or reducing food absorption. In contrast, AOD9604 is a peptide analogue derived from human growth hormone that has the fat metabolism properties without the growth properties associated with the full-length hormone. "

The company would now focus on signing up a suitable pharmaceutical partner prior to commencing worldwide Phase III trials in the second half of 2005, Belyea said: "We've been courting [pharmaceutical companies] for between one and a half and two years -- they like the story and are getting serious about it."

The company was in a good position to negotiate a very favourable royalty rate on the drug, according to Belyea, who noted that the company would be looking for a partner to support both Phase III development and marketing activities.

The success of the lowest dose tested in the trial was also good news for the company, Belyea said, as it suggested that an even lower dose might be effective. In addition, it would significantly reduce manufacturing costs, he said.

The success of Metabolic's trials has long been seen as an important bellwether for the Australian biotechnology industry, and Belyea indicated that he was aware that the sector had been following the progress of the trial with keen interest. "This is the most significant effort and significant success in Australian biotechnology to date," he said.

Bioshares co-editor and industry analyst Mark Pachacz said the result was a great way to end the year. "This is a good Christmas present for the whole sector," he said.

Following the lifting of a two-day trading halt, the opening price of Metabolic shares was AUD$2.50, up 28 per cent on the previous close of $1.96. At the time of writing, the shares were trading at a price of $2.17 on heavy volumes.