Metabolic unveils obesity drug trial details

Melbourne-based Metabolic Pharmaceuticals (ASX:MBP) has clarified details of a previously announced Phase IIb trial of its anti-obesity drug AOD9604, with recruitment expected to commence in September or October this year.

Analysis of results from last year's Phase IIb study of the drug suggested that the optimal dosage was potentially below the lowest dose of 1mg used in the trial and the new Phase IIb study will test three different daily doses -- tablets of 1mg, 0.5mg, 0.25mg and placebo.

"Clearly we would like to have gone from our previous trial to Phase III -- the fewer trials you have to do, the faster the process," said Metabolic CEO Roland Scollay. "It's also not unusual with complex biologicals, like this one, or with any therapeutics, that unexpected things come up during trials and you have to get more information."

Metabolic is currently manufacturing tablets and preparing submissions for institutional ethics committees for approval at the selected trial sites.

"They are the two things which are rate limiting to begin this process," said Scollay. "Our best prediction is that September/October will be the beginning of [trial] recruitment."

Recruitment of about 480 obese men and women is anticipated for the new trial, compared with the previous trial which recruited 300 obese patients. Between 10 and 15 clinical trial sites throughout Australia and New Zealand will participate.

As with the previous trial, the primary efficacy endpoint will be weight loss after 12 weeks of treatment, but patients will be treated for a total of 24 weeks to gather information on the longer-term benefits of the drug. Metabolic expects to complete the 24-week dosing period late next year.

Metabolic estimates that the trial will cost AUD$8-10 million and is currently looking for partners. If a partner is not found in time, the company will need to raise additional equity to cover capital requirements.

"We have ongoing conversations with a number of significant pharma companies on the partnering but we're not making any predictions as to timing or outcomes," said Scollay.

Slight delay

Dianne Glenn, an associate director at Sydney investment bank EG Capital, said it had been suggested by Scollay's predecessor as Metabolic CEO, Chris Belyea, that the dosage trials would begin in mid-2005. But she said she was not surprised that the start of the trial had been put back.

"The dosage trial is very significant for the development of this product, in terms of it going on to Phase III," she said. "[Also], Metabolic now has a new CEO and I'm quite sure that he has taken some time to reassess Metabolic's strategic direction."

Glenn said recruitment for the last trial had been "reasonably slow".

"But [the new trial] has about 50 per cent more patients, so it's going to take a lot longer -- I'm not surprised that the new CEO has recruited twice, if not three times, the number of study centres."

Glenn pointed out that patients recruited for the trial needed to be obese, but could not have consequences of obesity such as type 2diabetes, high blood pressure, or cardiovascular issues.