Experimental Drug Ketasyn(TM) (AC-1202) Treats Alzheimer's As Diabetes Of The Brain

Accera, Inc. announced today
that recent data from its Phase IIb study in Alzheimer's disease (AD)
support findings showing that AD may effectively be thought of and treated
as diabetes of the brain.



AD is widely believed to be caused by the accumulation of amyloid beta
plaques in the brain, yet recent research from Brown University has shown
that inducing insulin resistance in the brains of mice gives rise to some
of the behavioral and pathological symptoms of AD. AD may therefore be
thought of as brain-specific "type 3 diabetes," an idea that is further
supported by brain images of AD patients showing decreased glucose
metabolism.



All cells in the body require glucose, which is controlled with the aid
of the hormone insulin. In type 2 diabetes, which accounts for 90% of the
180 million diabetes cases worldwide according to the World Health
Organization, certain cells become resistant to insulin and therefore
cannot take in enough glucose. When brain cells become insulin-resistant,
as happens in AD, inadequate glucose leads to damage that results in
impaired memory and cognition and brain shrinkage.



Because these metabolic defects in the brain often appear 10 to 20
years earlier than other AD symptoms, targeting them may allow for earlier
treatment of the disease. Based on this hypothesis, Accera is developing
the AD drug, Ketasyn(TM) (AC-1202), which provides glucose-deprived brain
cells with an alternative energy source. Ketasyn is converted by the liver
into ketone bodies, which brain cells can use for energy even when their
ability to metabolize glucose is impaired.



Dr. Samuel Henderson, Executive Director of Research at Accera, said,
"While many drugs currently under development for AD target production and
clearance of amyloid beta plaques, our approach is to address a much
earlier event. Declines in glucose use are visible decades before there is
extensive amyloid deposition and decades before clinical signs of dementia
are evident. We hope that our early intervention in this process will have
a significant impact on the disease."



Accera recently completed Phase IIb clinical trial that confirmed
Ketasyn's safety and efficacy as measured by improvement in ADAS-Cog
scores, the FDA's gold standard measure for efficacy in cognition and
short-term memory. As in earlier studies, Ketasyn was particularly
effective in a subgroup lacking the APOE4 genotype, which represents half
of the Alzheimer's population.



APOE4 is a known major risk factor for late onset AD, which is the most
common form of the disease. Interestingly, other treatments aimed at
tackling the "type 3 diabetes" hypothesis have yielded similar results: AD
patients lacking the APOE4 genotype have responded positively to an
insulin-sensitizing drug, and to direct exposure to insulin, while patients
expressing the APOE4 genotype showed little or no response.
















"The different responses in people of varying APOE4 status with Ketasyn
and other treatments indicates that APOE4 is altering something fundamental
about brain metabolism," said Dr. Henderson. "These findings are consistent
with studies demonstrating differential insulin sensitivity based on APOE4
status. Our study has provided us with valuable insights for our future
research."



Accera plans to initiate a pivotal, Phase III multi-center clinical
trial in early 2008 in mild-to-moderate Alzheimer's patients who do not
have the APOE4 genotype. This study will focus on several measures of
efficacy, including ADAS-Cog, safety and the role of insulin regulation in
Alzheimer's disease.



About Ketasyn(TM)



Brain imaging techniques performed on AD patients reveal a dramatically
decreased uptake of glucose, the brain's preferred source of energy.
Ketasyn(TM) (AC-1202) is an orally available, liquid compound that is
efficiently metabolized by the liver to ketone bodies, an alternative
energy source that the brain can utilize when glucose metabolism is
compromised. Ketasyn has disease modifying potential in AD and a number
other neurodegenerative diseases characterized by neuronal hypometabolism.
The potentially neuroprotective mechanism of this first-in-class compound
is also being evaluated in clinical trials for age-associated memory
impairment and Parkinson's disease.



About Accera, Inc.



Based in Broomfield, CO, Accera, Inc. is a privately held biotechnology
company focused on developing novel drugs for neurodegenerative diseases.
The company's lead candidate, AC-1202, is a first-in-class molecule that
has recently completed Phase II clinical trials for Alzheimer's disease and
Age- Associated Memory Impairment. Accera has other small molecule
compounds in its product pipeline for a range of other neurodegenerative
diseases including Parkinson's disease and Huntington's disease.


Accera, Inc.

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