glad i got the 82, page-25

re: investor update just out CEO starts work
„h AOD9604 obesity drug
- Preparations under way for next AOD9604 trial Q3 2005
- Further analysis of trial data and follow-up data
- Partnering discussions progress move up
„h ACV1 pain drug near to Phase 1 start
„h Collaboration with Neuren on new joint project
„h Level 1 ADR Program update
„h Future capital requirements
We are pleased to provide this update on the progress of AOD9604 and the
Company¡¦s other activities.
New CEO starts work
As advised in a previous announcement, Metabolic has appointed a new CEO,
Dr Roland Scollay, for the next phase of our development. The founder and
current CEO, Dr Chris Belyea remains with Metabolic as Chief Scientific Officer
and a member of the Board of Directors, with executive responsibility for
technical and scientific interactions on the company¡¦s projects including
AOD9604.
Dr Scollay commenced the role in mid February and since that time has been
active in promoting the company. In late February he gave an invited
presentation at a BIO CEO conference in New York, sitting on an Obesity Panel
session. Details of an audio webcast of the presentation and discussion are
available on the Metabolic website. Dr Scollay is currently making investor
presentations throughout Australia.
Dr Scollay said:
¡§It is an exciting time for me to be joining Metabolic in an executive role, having
served on the Board as non-executive director for two years. The phase 2b
human clinical trial on our obesity drug AOD9604 has shown that this drug has
real potential as a distinctly new and potentially superior treatment for obesity.
The trial did not answer all the questions we had hoped it would answer, indeed
2
as so often happens in clinical trials, raised a few more. These can be answered
in the next study. However, it can be confidently stated that the trial data
considered as a whole, provides strong evidence that AOD9604 produces
competitive weight reduction in humans with very encouraging safety and
tolerability. These findings are good news for the potential penetration of this
drug into a large proportion of the possible user population. In the USA, 60% of
adults are ¡§overweight¡¨ and 5% are at least 45Kg overweight. Australia and the
rest of the world are catching up quickly, so this is potentially an enormous
market. In my view Metabolic has the most promising drug in this field and I look
forward to leading the company to the commercialisation of this and our other
innovative projects. ¡§
AOD9604 obesity drug
Preparations under way for next AOD9604 trial Q3 2005
Results from our 300-patient Phase 2b trial in December provided evidence that
AOD9604, the world¡¦s first metabolic obesity drug, induces weight loss at a
competitive rate with a very encouraging safety and tolerability profile and
indications of accompanying metabolic health benefits.
The results also indicated that optimum daily dose for the compound, for both
men and women, is most likely at or below the lowest dose we used in the trial,
1mg.
Although the surprising potency of the drug is good news from the point of view
of future manufacturing cost, this means that before a Phase 3 trial can be
initiated, further information on the optimum dose needs to be obtained by
investigating doses lower than 1 mg.
The protocol for this next study will depend in part on whether Metabolic moves
forward with the assistance of a collaboration deal with a large pharmaceutical
company or goes ahead with the next study independently (see below).
Aggressive trial designs such as dose-finding studies leading in to Phase 3 are
only possible with the financial support of a party able to fund the dose finding
and Phase 3 studies concurrently, but this choice will become clear in the coming
months.
Although partnering discussions are in progress, we are conscious of the need to
keep moving rapidly on the development of this very promising drug and are
planning a further value-adding Australian-based dose-finding study.. This trial
can be commenced this year and will answer at least the main question: ¡§is the
optimal effective dose lower than 1mg?¡¨ and possibly other important questions
such as ¡§what is the effect of treatment beyond the 12 weeks studied to date?¡¨.
Studies on the other drugs in the market show a reduced effect after the first
three months of treatment.
3
The time critical activity for the commencement of this trial is the development
and supply of low dose tablets. These have been under development by a
contract formulation company in the US since early January.
Our projections are to have clinical trial supplies available by mid-year and
consequently the start of this trial is scheduled for Q3 2005.
Partnering activities may cause these plans to be changed.
Further analysis of trial data and follow-up data
The detailed report on the Phase 2b trial results provided the preliminary results
of the analyses set out in our Statistical Analysis Plan, which according to best
clinical practice was laid down before the blind was broken and the data was
inspected. According to this plan, the analysis was performed in relation to all the
data up to one month after the end of treatment.
The statistician has now provided the final report in relation to those results and
there are no material differences from the data analysis as reported in
December. As previously advised, the primary analysis of weight loss produced a
competitive figure for the 1mg dose which was slightly short of statistical
significance, although the secondary ¡§repeated measures¡¨ analysis of rate of
weight change did reach significance.
The patients in the trial have now all completed a 3-month post-treatment followup
visit and the data are currently under analysis. The information of the greatest
interest is the weight change of the patients in this period. With appetite
suppressant weight loss drugs, weight increases (rebounds) to some degree
after cessation of treatment. In this trial, the data already reported show that
over the 1 month post treatment there was no evidence of rebound. Further
details of this very positive aspect of the results will be provided when analysis of
the 3 month follow up is complete.
A manuscript of the trial results is currently in preparation for submission to a
peer-reviewed journal.
Partnering discussions progress
We receive many requests from investors to provide an update on partnering
discussions. Due to the strictly confidential nature of this process, there is very
little information we can add since our last communication on this subject. We
can advise, however, that more than 10 of the world¡¦s leading pharmaceutical
companies have asked us to send them our confidential data package since the
results were released in December.
Detailed packages containing all of the relevant data were provided in mid
February. We are now engaged in the process of detailed technical interactions
with several evaluation teams concerning the data package and potential
collaboration parameters.
4
Outcomes of partnering discussions are highly unpredictable and there can be no
guarantee of arriving at mutually agreeable terms or any certainty of timeline.
ACV1 pain drug
ACV1 represents an entirely novel approach to the treatment of chronic pain, the
most significant problem in pain management. Metabolic licensed ACV1 from
scientists at the University of Melbourne in late 2003. ACV1 fits well with the
corporate strategy of developing peptide therapeutics with novel mechanisms of
action which address large market indications.
Since we acquired the ACV1 license, progress on preparing the compound for
clinical development has been excellent. The data from preclinical efficacy and
toxicology studies is now in hand to support human dosing of ACV1 in Phase 1
and Phase 2a human clinical trials. The package is currently being compiled for
submission for approval to the Royal Adelaide Hospital ethics committee to
commence a Phase 1 human clinical trial in healthy volunteers.
Dosing in the Phase 1 single and multiple dose study by subcutaneous injection
is scheduled to begin in Q2 2005.
Collaboration with Neuren on new joint project
On 3 March we announced that Metabolic and Neuren (ASX:NEU) have agreed
to collaborate to co-develop Neuren¡¦s class of Neuro-regenerative Peptides
(NRPs) for the treatment of degenerative conditions such as peripheral
neuropathy, motor neuron disease and repairing the brain or nerves after injuries
such as spinal cord injury. The parties will jointly develop the NRP project with all
intellectual property and commercial outcomes to be equally shared. This joint
development benefits both companies and complements Metabolic¡¦s current
development activity with ACV1 in the neuro-active peptide field.
Over the next 18 months Neuren and Metabolic will work together to develop a
lead compound for clinical development and assess its efficacy in a range of
animal models of neuropathic conditions, including large market diseases of the
peripheral nervous system such as diabetic neuropathy, motor neuron disease
and extremely challenging conditions such as regrowth of nerves after spinal
cord injury.
When sufficient supporting data are in hand the companies intend to promote the
lead molecule into formal preclinical development and to enter into clinical
development for the most promising indication.
5
Level 1 ADR Program update
The company is currently implementing level 1 American Depositary Receipts
(ADR) program. We aim to have the ADRs operative in the US market by May
2005. This will enable US investors to acquire Metabolic¡¦s securities in their own
market.
The management time,setup and ongoing compliance costs of a full Nasdaq
listing are substantial. Metabolic plans to establish a full Nasdaq listing (level 2
ADR) as soon as it can be justified, but at the current time resources are better
devoted elsewhere.
Future capital requirements
The Company currently has more than $10 million in funds. This will be sufficient
to run all of the company¡¦s development projects over the next 12 months.
Our future need to raise capital by share placement will depend strongly on the
partnering progress on AOD9604.
About Metabolic
Metabolic Pharmaceuticals Limited is a biotechnology company based in
Melbourne, Australia, and is listed on the Australian Stock Exchange (ASX:
MBP). 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 - Phase 2b trial completed),
neuropathic pain (ACV1 ¡V Phase 1 to commence in Q2 05), and type 2
diabetes. For more information, please visit the company¡¦s website at
www.metabolic.com.au.
Background to AOD9604
AOD9604 is a small, orally active peptide modelled 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. Replacement of growth
hormone by daily dosing with AOD9604 is believed to normalise suppressed fat
metabolism in obese individuals, while avoiding unwanted effects of the whole growth
hormone molecule.
Background to ACV1
ACV1 is the first in a potential new class of drugs to specifically treat neuropathic (nerve)
pain. Current therapies rely largely on the ¡¥off-label¡¦ use of anticonvulsants,
antidepressants and local anaesthetics, which have unimpressive efficacy and doselimiting
side-effects. The potential range of indications for ACV1 extend to neuropathic
6
pain in diabetics, post-herpetic neuralgia (¡§shingles¡¨), sciatica and many other
neuropathic pain conditions currently underserved by pharmaceutical treatment
ACV1 specifically blocks a subtype of a class of receptors in the peripheral nervous
system called neuronal nicotinic acetylcholine receptors (nAChR). ACV1 can be
administered by once daily subcutaneous injections providing substantial relief in several
animal models of neuropathic pain without apparent adverse effect. Phase 1 clinical
trials are planned for 2Q 2005.
Contact Information:
Roland Scollay ¡V CEO, [email protected]
David Kenley ¡V VP Corporate Development, [email protected]
Phone : +61-3-9860-5700