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Metabolic Pharmaceuticals Initiates Recruitment for Phase II-B Clinical Trial of AOD9604 Obesity Drug

Posted on: Tuesday, 18 October 2005, 09:00 CDT

MELBOURNE, Australia, Oct. 18 /PRNewswire-FirstCall/ -- Metabolic Pharmaceuticals Ltd / (BULLETIN BOARD: MBLPY) , today announced it has initiated the recruitment process for subjects in the low dose Phase II-B human clinical trial of its obesity drug, AOD9604. The trial will be known as the "OPTIONS" study.

Sixteen clinical trial sites in Australia will participate in the study enrolling 480 obese men and women. The sites are located in Melbourne, Sydney, Wollongong, Adelaide, Brisbane, Perth and Canberra. Ethics approvals have been obtained at two sites and the approval process is well advanced at each other site. Recruitment has started at one site, and it is anticipated that screening of candidates for enrolment into the study will commence within a few weeks.

With recruitment now underway, it is anticipated that the first subject will be treated within the next few weeks. Given the staggered and time- consuming nature of the recruitment process, the last subject is expected to complete the study in early 2007.

"We are delighted that the Phase II-B clinical trial for AOD9604 is commencing on schedule," said Dr Roland Scollay, Chief Executive Officer. "Given the encouraging trial results we have had to date and the blockbuster potential of this drug, we anticipate substantial local and international interest in the OPTIONS study. Naturally, we are very excited about the prospects."

Aims of the Trial

The previous Phase II human clinical trial of 12 weeks AOD9604 daily oral treatment was completed earlier this year using doses ranging from 1 mg to 30 mg. That trial provided evidence that low doses of AOD9604 of 1 mg produced competitive weight loss in obese subjects, with encouraging indications of improvement in risk factors for diabetes.

The OPTIONS Study will assess the effects of low doses of AOD9604 in more detail.

The primary aims of the OPTIONS study are:

* weight loss over 12 weeks of treatment for any one of three daily AOD9604 oral doses of 0.25 mg, 0.5 mg and 1 mg, compared to placebo (tablet not containing AOD9604); and

* safety and tolerability. Secondary aims of the OPTIONS study include investigations of: * weight loss over 24 weeks of treatment; * comparison of the effects of the three different dose levels; * waistline reduction over 24 weeks of treatment; * body fat reduction assessed by whole body scans; and

* improvement in risk factors such as glucose control and lipid profiles over 24 weeks of treatment.

Study Design

The recruitment of 480 obese subjects (equal numbers of males and females) into the trial is expected to ensure that approximately 360 subjects will reach the primary endpoint of 12 weeks of treatment. Key eligibility criteria are that the subjects must have a body mass index (BMI)* between 30 and 45, a waist circumference of more than 102 cm for males and 95 cm for females, be otherwise healthy and aged between 18 and 65 years.

* BMI is weight in kilograms divided by the square of the height in meters. Eg: 95 kg and 1.7 meters tall is 95/(1.7x1.7)=32.9. "Obese" is defined as BMI of 30 or above.

This is a randomized, double-blind, placebo-controlled, parallel-group trial that will be conducted in accordance with the Principles of the International Conference on Harmonization (ICH) Good Clinical Practice (GCP).

The subjects will be randomly assigned to one of four dose level groups, to take tablets once daily for 24 weeks containing either zero, 0.25 mg, 0.5 mg or 1 mg AOD9604 active ingredient. All subjects will be placed on an exercise program and a mild calorie-reduced personalized diet (600 kilocalories per day deficit). This makes the protocol highly predictive of a future larger scale Phase III human clinical trial, which would also include a similar diet and exercise program in addition to drug or placebo treatment.

The number of subjects were chosen to give an 80% probability of obtaining statistical significance (p<0.05) on the primary endpoint, assuming the same dropout rate, weight loss effect size at the 1 mg dose, and degree of variation in weight loss seen in the previous study.

Timeline for completion

Once enrolled in the study, each subject will spend a total time of 32 weeks including pre-dosing and post dosing observations. The study will be unblinded and the data analyzed after the last subject has completed the study, which is expected to occur in early 2007. This assumes it takes six months from the first subject enrolment to the last. The fully analyzed results will be reported as soon as practicable thereafter. A more accurate prediction of the announcement date will be possible to determine once the trial is in process.

Metabolic Pharmaceuticals Limited is a biotechnology company based in Melbourne, Australia, and is listed on the Australian Stock Exchange and there are 254,410,601 shares on issue. The company's mission is to develop a pipeline of new pharmaceuticals for world markets and currently has development programs aimed at treating obesity (AOD9604) and neuropathic pain (ACV1 - Phase 1 commenced in Q2 2005). For more information, please visit the company's website at http://www.metabolic.com.au/.

Background to AOD9604

AOD9604 is a 16 amino acid, orally active peptide modeled on one segment of the human growth hormone molecule. Growth hormone occurs naturally in the body and has profound stimulatory effects on fat metabolism. Levels of the hormone are typically suppressed in the obese state and with increasing age. Counteraction of this imbalance by daily dosing with AOD9604 is believed to normalize suppressed fat metabolism in obese individuals, while avoiding unwanted effects of the whole growth hormone molecule. AOD9604 has been through a Phase 2B clinical trial that showed good indications of efficacy and an excellent tolerability profile, and a further low dose study commenced in October 2005, with expected completion in early 2007.

Further information Company: US Investors: Roland Scollay, CEO Kathy Price, Tel: +61 3 9860 5700 The Global Consulting Group Email: roland.scollay@metabolic.com.au Tel: 212-983-1702, x212 Email: kprice@hfgcg.com

Metabolic Pharmaceuticals Limited

CONTACT: Roland Scollay, CEO of Metabolic Pharmaceuticals Ltd.,+61-3-9860-5700, or roland.scollay@metabolic.com.au; or US Investors, KathyPrice of The Global Consulting Group, +1-212-983-1702, x212, orkprice@hfgcg.com

Web site: http://www.metabolic.com.au/

Source: PRNewswire-FirstCall

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