Experimental Drug Ketasyn(TM) Improves Memory in Age-Associated Memory Impairment Study

Aug 29, 2007, 01:00 ET from Accera, Inc.

    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.
      Meghan Feeks
      (212) 827-0020

SOURCE Accera, Inc.