Metabolic CEO keen to prove worth of lead drugs

Metabolic Pharmaceuticals (ASX:MBP) CEO Dr Roland Scollay is feeling no pain as his Melbourne-based biopharmaceutical company heads into a potentially momentous year in the clinic for its two lead compounds, the anti-obesity drug AOD9604 and chronic neuropathic pain lead ACV1.

"We're extremely excited and upbeat about this drug (AOD9604)," Scollay said. "Basically, we're now testing its efficacy in a low-dose phase II trial."

Metabolic has already recruited 88 of the 480 subjects it needs for a phase IIb dose-ranging trial in obese males and females with a body mass index (BMI) between 32 and 45. Recruiting should be complete by April or May, and Metabolic expects to have the results early in 2007 to show its growing retinue of suitors -- which includes most of the world's big pharma companies.

That interest, said Scollay, puts the Metabolic weight-loss molecule "very firmly back on track" after investors took fright at media reports of an apparent lack of efficacy in its first dose-ranging trial last year.

"We moved on from that long ago, but it left some investors uncertain, because they weren't sure what the data meant," he said. "The data showed clearly that the drug worked. We now understand the dosage issue, but it's absolutely true that it had to be resolved.

"Basically, we believed we were looking at a bimodal dose-response curve, with two peaks of activity, at high and low dosages. We went back to the lab, and we've now clearly demonstrated this to be the case.

"Essentially, the new trial is investigating the lower peak of activity. The hypothesis is that it's a physiological response: we get a response at the low-dose end, but as the dosage increases, physiological feedback inhibits this primary activity.

"Then, when you give a massive dose, it overrides the physiological mechanism and we get a second peak of activity, indicating a different mechanism is involved."

The new phase IIa trial will differ from the first, by requiring volunteers to undertake a calorie-restricted diet, Scollay said. "We had some indications from the first trial that patients who voluntarily dieted did significantly better on the drug. If that proves to be the case, when all patients are put on a diet, and compliance is good, we should bring in a better result than we got from the last trial."

He believes the equally strong prospects of the company's second lead compound, the potent, analgesic ACV1, from a cone shell toxin, have been overlooked because of the publicity surrounding its anti-obesity drug -- yet both are potential multi-billion dollar drugs, with little or no competition in their respective market sectors.

"ACV1 a bit of a sleeper -- the market is hardly noticing," Scollay said. "It's such an interesting drug, it's had a beautiful run through phase I, and we're now in advanced planning for a IIa trial in the first half of this year.

"In terms of safety, it looks faultless. It doesn't cause numbness, it seems to have a very wide therapeutic window, and the pharmacokinetics are all textbook."