Metabolic braces itself for a busy year

By Melissa Trudinger
Thursday, 26 August, 2004

Metabolic Pharmaceuticals (ASX: MBP) is preparing for a busy year, with the results due in November for its critical Phase IIb clinical trial of obesity drug AOD9604 and the move into formal preclinical development for a second product.

This week, the company reported a net loss of AUD$9.5 million, an increase of 11 per cent over last year's results. Revenues increased by 382 per cent to $2.8 million, of which $2 million came from grant income.

CEO Chris Belyea said that, with more than $17 million in the bank at the end of the financial year, the company was in good shape going forward.

"Our current projections are for there to be $11 million in the bank at the end of the Phase IIb trial," he said.

He said the company was looking for partners to assist with the Phase III trials of AOD9604, which are scheduled to commence in mid-2005 in Australia, USA and Europe, but was prepared to go it alone if necessary.

"It all depends on the data whether we go with a partner or not," Belyea said. "All the activity will be in November."

The company is also preparing to take its second product, a drug for the treatment of neuropathic pain based on the venom of a cone shell snail, into the clinic. It has commenced formal preclinical studies with the intention of commencing clinical trials early next year.

Key events in 2003-2004:

  • Raised $6.1 million in November through a share purchase plan, and a further $4.9 million in May in a placement to QIC and Acorn Capital;
  • Commenced a 300-patient multi-centre Phase 2B clinical trial for obesity drug AOD9604, with results scheduled for November 2004;
  • Advanced the preparation of AOD9604 for future Phase 3 clinical studies by progressing ongoing toxicology studies, manufacturing development and the basic science of AOD9604 action;
  • Appointed a US Clinical Advisory Panel on obesity to advise on further AOD9604 clinical development;
  • In-licensed ACV1, a peptide compound with potential for the treatment of neuropathic pain, and commenced formal preclinical studies in preparation for Phase 1 human clinical trials in early 2005;
  • Continued early preclinical evaluation of other compounds in three separate therapeutic areas - type 2 diabetes, osteoporosis and iron overload, reaching decision points in respect of two of them;
  • Evaluated other potential compounds for possible in-licensing.
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