MELBOURNE, Australia, Oct. 5 /PRNewswire-FirstCall/ -- Metabolic Pharmaceuticals (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.
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 About Metabolic
Metabolic Pharmaceuticals Limited 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 Studies in a limited Trials undertaken study in patient population to further healthy human designed to: evaluate dosage subjects or - identify possible and clinical patients. adverse effects and efficacy and to safety risks in the further test for patient population(2A); safety in an expanded patient Phase 1 trials - determine the efficacy population in usually run of the product for clinical study for a short specific targeted sites throughout duration. diseases (2B); and major target - determine tolerance and markets (e.g. USA, optimal dosage (2B). 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
Metabolic Pharmaceuticals LimitedCONTACT: Roland Scollay, Chief Executive Officer, +61-3-9860-5700,roland.scollay@metabolic.com.au; Peter Dawson, Chief Financial Officer,+61-3-9860-5700, peter.dawson@metabolic.com.au; Diana Attana, AssistantCompany Secretary/IRO, +61-3-9860-5700, diana.attana@metabolic.com.au
Web site: http://www.metabolic.com.au/
