BioWorld International Correspondent
SYDNEY, Australia - Metabolic Pharmaceuticals Ltd. now is looking for a pharmaceutical partner after what it said is a successful Phase IIb trial of its weight-loss treatment.
However, criticism from analysts over statistical significance caused the company to issue a second announcement Friday to clarify sections of the first.
Part of the second statement said that within 24 hours of the first announcement the company had received "unsolicited requests for meetings and further data from several major international pharmaceutical companies with whom Metabolic has been discussing this project for over a year."
The company's stock had a wild ride. On the day of the announcement the stock price jumped 30 percent to A$2.50 (US$1.90) before settling back to A$2.04. After the criticism of the trial became known, the stock fell to A$1.20, then bounced back to end the week on A$1.50.
Scott Power, an analyst at the Brisbane office of ABN-Amro, said that Metabolic's stock price had proved "volatile," but now the company had to see what deal it could get.
"The next step is for the company to package up the data it has and negotiate a deal," Power said.
Repeated calls to Metabolic were not returned.
In the initial statement on the 300-person trial involving daily oral dosing of a treatment based on a fragment of the human growth hormone, Metabolic said that the average weight loss during the 12-week trial was about 2.8 kilograms. That result is almost three times the weight loss for the placebo group and was achieved with no significant side effects.
In addition, the weight loss continued throughout the trial, rather than slowing toward the end as it has for other drugs, indicating that longer trials might result in larger weight loss.
The company said that overall weight loss in excess of the placebo treatment was slightly more than indicated by the published data for the market leader, Xenical, marketed by F. Hoffmann-La Roche Ltd., of Basel, Switzerland. But it is understood that Xenical can cause gastrointestinal problems.
The second-ranking drug on the market, appetite suppressant Meridia (Abbott Laboratories, of Abbott Park, Ill.) records slightly more weight loss but has adverse effects on heart rate.
Metabolic issued the second release to counter a report by an analyst that pointed to the primary analysis of the connection between weight loss and dosage of the treatment, known as AOD9604. The primary analysis found that there was a 90 percent chance the 1-mg daily dose (the dose that gave the best result) induced weight loss - less than the 95 percent confidence called for in statistical significant results.
The more sensitive secondary analysis gave a result of 99 percent, but a Phase III trial would require a 95 percent result on the primary analysis to gain marketing approval.
Metabolic's reply stated that the primary result is very close and in any case, recent clinical trials were not Phase III, but Phase II and aimed at providing evidence to justify further development. That objective was achieved, it said.