Metabolic announced the successful completion of its Phase 2A human clinical trial of obesity drug AOD9604 by single-dose oral administration, showing positive results.
"This landmark result is the company's most important milestone achieved to date. Oral administration, the preferred mode of drug delivery, will maximize the commercial potential of AOD9604," said Chris Belyea, Managing Director.
"In all the trials performed so far, AOD9604 has consistently shown that humans respond to AOD9604 with increased fat metabolism, without side effects having been seen. This latest result provides key evidence that the oral activity shown in animals also applies to humans. We look forward with anticipation to forthcoming trials and our expectation is that AOD9604 will safely produce a meaningful weight reduction after daily oral dosing."
Increased average fat breakdown compared to placebo was observed at all dose levels of AOD9604 (9, 27 and 54 mg) lasting several hours after administration, reaching statistical significance at 27 mg. Fat breakdown, a signal of drug activity, is followed in the blood by measuring levels of non-esterified fatty acids (NEFA). NEFA is a marker, evident after a single dose, of fat metabolic changes that are expected to result in weight loss after extended daily dosing.
Preparations are now under way for a safety study dosing once daily for one week to be conducted before year end in preparation for an extensive weight reduction study for 2003.
The drug is modelled on the active fat reducing portion of the human Growth Hormone (hGH) molecule. hGH occurs naturally in the body and is involved in promoting growth. In addition it has pronounced effects on body fat. Scientists at Monash University have shown that, when dosed to animals, AOD9604 has the fat-reducing effects of the intact growth hormone without its other unwanted effects having been observed.