parisrory said:
Over 15% today, no results due until March 07, any ideas why?
..........I think no side effects etc etc are a plus......Mind you there might be side affects when the share hits the weighting scales next march! happy reading .......Read on :
ASX Announcement ASX code: MBP
Metabolic’s obesity trial update: First 100 subjects
complete the Phase 2B trial of AOD9604
• The first 100 subjects have now completed the Phase 2B OPTIONS Study including
24 weeks of daily oral dosing of obesity drug, AOD9604
• The last subject will complete the trial ahead of schedule in December 2006 with
results expected to be announced in March 2007
Melbourne, 5 October 2006: Metabolic Pharmaceuticals Limited (Metabolic) announced today that the
first 100 subjects have completed the Phase 2B OPTIONS Study for obesity drug, AOD9604. The
OPTIONS Study is designed to assess weight loss at lower doses of AOD9604 than previously tested.
The OPTIONS Study reached full recruitment with 536 subjects ahead of schedule in late April this
year and as a result, the study will also finish ahead of schedule, in December 2006. The OPTIONS
Study includes 24 weeks of randomised double-blind drug or placebo treatment, with the primary
endpoint of weight loss at 12 weeks. More than 100 subjects have already completed the full 32-week
protocol, and all remaining subjects will have completed the trial in December 2006. Metabolic expects
to announce the results of the study in March 2007, once the database is finalised, the blind is lifted
and the data analysed.
Dr Roland Scollay, CEO of Metabolic, commented “we are very pleased with the clinical progress of
our obesity drug. AOD9604 has shown no negative side effects in studies completed so far and is the
only obesity drug in advanced development with a primarily metabolic mode of action. Furthermore,
the previous study showed no evidence of the post-treatment weight rebound that is typical of other
weight loss drugs. The potential commercial benefits of these competitive advantages are significant”.
Background to AOD9604 and obesity
AOD9604 is an orally active, 16-amino acid, peptide drug, based on a fragment of human Growth
Hormone (hGH).
AOD9604 has undergone numerous safety and tolerability checks through human clinical trials, and
a previous Phase 2 efficacy trial demonstrated a very competitive 2kg weight loss more than
placebo over a 12 week period, as well as other benefits such as improved cholesterol profile.
The drug’s competitive advantages are its good safety and side effect profile and its novel
mechanism of action - AOD9604 addresses metabolism (fat burning) rather than acting as an
appetite suppressant.
The current global market for prescription obesity drugs is estimated at approximately
US$1 billion a year with very high growth forecast, estimated to reach US$10-30 billion a year if
safe and effective weight loss drugs become available.
Previous announcements regarding this trial, made on 18 October 2005, 23 January 2006,
2 May 2006 and 19 July 2006 are available at
www.metabolic.com.au following the tabs to Investor
Relations. The complete trial design is included in the appendix to this announcement.
- ENDS -
Page 2 of 3
Appendix: the OPTIONS Study trial design
Number of subjects: 536 subjects enrolled, approximately equal number of men and women
Subject selection criteria: BMI* (Body Mass Index) 30-45 kg/m2;
Age 18-65 years; and
A waist circumference of more than 102 cm for males and 95 cm for
females, in otherwise healthy subjects.
Expected completion date: Last subject will complete the study in December 2006, results
expected in March 2007
Blinding status: Double-blinded (neither treating doctor, nor subject, nor Metabolic
knows whether the subject is receiving drug or placebo)
Placebo controlled: Yes (one group receives only placebo – a tablet that looks the same as
AOD9604 but has no drug content)
Treatment route: Oral (tablets)
Treatment frequency: Once per day
Dose level: Dose groups of 0, 0.25, 0.5 and 1 mg
(the 0 group is the placebo group)
Primary end points: 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; and
Safety and tolerability.
Secondary end points: 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.
Trial sites: 16 clinical trial sites throughout Australia
Contract Research Organisation: Kendle Pty Limited
Page 3 of 3
About Metabolic
Metabolic Pharmaceuticals Limited (ASX: MBP, NASDAQ OTC: MBLPY) is a Melbourne based, ASX listed biotechnology company with 285 million
shares on issue. The Company employs 24 staff and is led by an experienced and proven management team. Metabolic’s main focus is to take
innovative drugs, with large market potential, through formal preclinical and clinical development. Metabolic’s expertise in drug development has
resulted in two high value drugs in advanced human clinical development, namely:
- AOD9604 - an obesity drug currently in a Phase 2B trial with results expected in March 2007;
- AOD9604 - additional use in osteoporosis with a Phase 2 trial expected to commence in 2007; and
- ACV1 - a neuropathic pain drug currently in Phase 2A trials.
These drugs address multi-billion dollar markets which are poorly served by existing treatments. In addition to its lead drugs, Metabolic has an exciting
research pipeline with drugs targeting type 2 diabetes (ADD) and nerve regeneration (NRPs). Metabolic is also developing a platform to enable oral
delivery of existing injected peptide drugs, a technology which has already shown proof-of-concept. This has high potential for use by other companies
developing peptide drugs and could foster multiple out-licensing deals.
Metabolic plans to license its lead drugs to a global partner following Phase 2 trials and will continue to utilise its clinical development expertise to drive
future company growth and profits
For more information, please visit the company’s website at
www.metabolic.com.au.
Background information on the drug development process
The steps required before a drug candidate is commercialised include:
1. Discovery or invention, then filing a patent application in Australia and worldwide;
2. Pre-clinical testing, laboratory and chemical process development and formulation studies;
3. Controlled human clinical trials to establish the safety and efficacy of the drug for its intended use;
4. Regulatory approval from the Therapeutic Goods Association (TGA) in Australia, the FDA in the USA and other agencies throughout
the world; and
5. Marketing and sales.
The testing and approval process requires substantial time, effort, and financial resources and we cannot be certain that any approvals for any of our
products will be granted on a timely basis, if at all.
Human clinical trials are typically conducted in three sequential phases which may overlap:
Phase 1 Phase 2 Phase 3
Initial safety study in healthy
human subjects or patients.
Phase 1 trials usually run for a
short duration.
Studies in a limited patient population designed to:
- identify possible adverse effects and safety risks in the
patient population (2A);
- determine the efficacy of the product for specific
targeted diseases (2B); and
- determine tolerance and optimal dosage (2B).
Trials undertaken to further evaluate dosage
and clinical efficacy and to further test for
safety in an expanded patient population in
clinical study sites throughout major target
markets (e.g. USA, Europe and Australia).
Contact Information
Roland Scollay
Chief Executive Officer
roland.scollay@metabolic.com.au
T: +61-3-9860-5700
Peter Dawson
Chief Financial Officer
peter.dawson@metabolic.com.au
T: +61-3-9860-5700
Diana Attana
Assistant Company Secretary/IRO
diana.attana@metabolic.com.au
T: +61-3-9860-5700