Metabolic says AOD9604 for obesity also shows an effect in preventing osteoporosis

By E. Janene Geiss

Philadelphia, Jan. 31 - Metabolic Pharmaceuticals Ltd. said Tuesday that it has received data from collaborators demonstrating that daily oral administration of AOD9604 shows an effect in preventing bone loss and maintaining bone quality in a rat model of osteoporosis.

This potential new indication for AOD9604 is in addition to its use for obesity currently being evaluated in the clinic, according to a company news release.

The osteoporosis study, which includes about 90 rats, was conducted by a team of scientists under the direction of Marc Grynpas at the Samuel Lunenfeld Research Institute of Mount Sinai Hospital in New York, affiliated with the University of Toronto.

This result confirms a previous study performed at the same site in 2002 with injected AOD9604 at slightly higher doses, officials said.

"A new indication for an existing investigational drug is always positive news. AOD9604 already has the potential to be a multibillion dollar drug through its effects on obesity. An additional indication would increase the potential market size and therefore, royalty flow, in which much of the knowledge gained for the primary indication, such as safety profiles, manufacturing, formulation and drug stability could be used to support the new indication," Roland Scollay, chief executive officer, said in the release.

The company has been studying the biology of AOD9604 in a variety of models and commissioned this study using a well-accepted animal model of osteoporosis, officials said.

In this model, post menopausal estrogen loss was simulated in retired female breeder rats by surgical removal of the ovaries, which results in substantial fat gain and loss of bone quality and strength over the study period, officials said.

Once-daily oral treatment with AOD9604 for 12 weeks at two doses, 0.25 mg and 0.5 mg, reduced the post ovariectomy weight gain by about 50% compared to untreated controls, but also prevented the loss of bone mass and bone strength in cortical bone seen in untreated controls, officials said.

This study also has provided third party confirmation of the efficacy of AOD9604 in the treatment of obesity, the primary indication.

The company said it continues to focus on the progression of its low dose phase 2b human clinical trial of AOD9604 for obesity.

Metabolic is a Melbourne, Australia, biotechnology company developing two drugs, one for obesity and another for neuropathic pain.

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