BROOMFIELD, Colo., Aug. 29 /PRNewswire/ -- Accera, Inc. announced today
that recent data from a Phase II study of its lead compound Ketasyn(TM)
(AC- 1202) in age-associated memory impairment (AAMI) showed that Ketasyn
has a positive and clinically meaningful effect on memory in older adults.
AAMI is the decline in memory that occurs during the natural course of
aging, The National Institute of Mental Health criteria for AAMI include
complaints of gradual memory loss in everyday problems in persons more than
50 years of age. AAMI affects an estimated 10-15 million people in the
U.S., and may be a precursor to Alzheimer's disease (AD), which is expected
to afflict 11-16 million Americans in the next 40 years.
AAMI symptoms may be related to declines in glucose metabolism in the
brain that are also associated with aging. Glucose is the brain's primary
fuel source, so aging brains with impaired glucose metabolism require an
alternative source of energy. Ketasyn is an orally available compound that
is metabolized into ketone bodies, which the brain can use for energy even
when its ability to process glucose is impaired.
"The results of this study support the hypothesis that providing
additional energy reserves to the elderly brain improves a variety of
cognitive activities. They also provide further evidence of the roles that
glucose and insulin metabolism plays in cognition and memory," said Dr.
Lauren Costantini, Accera's vice president of clinical development. "As in
our earlier successful clinical studies in Alzheimer's disease, Ketasyn was
well tolerated by subjects in the AAMI study and we are encouraged by the
strong efficacy data."
The randomized, double-blind, placebo-controlled, parallel,
multi-center trial was conducted at six centers in the United States. One
hundred fifty- nine subjects diagnosed with AAMI received either Ketasyn or
placebo for 90 days followed by a two-week washout period. Mean age in this
study was 65. Subjects underwent genomic testing for variations in the
coding regions of genes known to influence memory and cognition, including
the apolipoprotein E gene (APOE), a known genetic risk factor for
Alzheimer's disease (AD) that occurs in 15-20% of the general population.
On days 0, 30, 60, 90 and 104, subjects were evaluated through a battery of
neuropsychometric tests that measure various aspects of memory and
Ketasyn showed significant efficacy in tests of memory. On average,
subjects taking Ketasyn performed significantly better on the 'First-Last
Name Association' test (FLN) than subjects taking placebo (p=0.042). "On
average, seniors taking Ketasyn remembered more names than those taking
placebo," said Dr. Costantini.
In another memory test called Name-Face Recognition (NFA), which
associates a person's name and face, Ketasyn subjects under age 59 improved
significantly more than placebo subjects at Day 90 (p=0.0217). The efficacy
in the NFA test observed with Ketasyn in subjects under age 59 captures a
large portion of the AAMI population.
Consistent with the findings of Accera's Phase IIa and IIb AD studies,
subjects who did not have the APOE4 genotype (E4(-)) responded particularly
well to treatment: E4(-) subjects showed a further significant treatment
effect of Ketasyn in FLN at Day 90 (p=0.012). In contrast, and also
consistent with the AD trial results, APOE4(+) subjects showed no
difference between Ketasyn and placebo for FLN scores at Day 90 (p=0.4639).
The safety profile of Ketasyn was excellent, as shown in the previous
AD trials with Ketasyn. The incidence of adverse events was low and similar
between Ketasyn and placebo groups.
Accera recently completed a Phase IIb clinical trial in AD patients
that confirmed Ketasyn's safety and efficacy as measured by improvement in
ADAS-Cog scores, the gold standard measure for efficacy in cognition and
short-term memory. Accera plans to initiate a pivotal, Phase III
multi-center clinical trial in early 2008 in mild-to-moderate AD patients.
This study will focus on several measures of efficacy, including ADAS-Cog,
safety and the role of insulin regulation in AD.
About Ketasyn(TM) (AC-1202)
Brain imaging techniques performed on aging adults and Alzheimer's
patients reveal a dramatically decreased uptake of glucose, the brain's
preferred source of energy. Ketasyn(TM) (AC-1202) is an orally available
compound that is efficiently metabolized by the liver into 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 decreased
glucose use in the brain, which is known as neuronal hypometabolism.
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. For more
information, visit: http://www.accerapharma.com.
Richard Lewis Communications, Inc.
SOURCE Accera, Inc.