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Accera, Inc. Announces Open-Label Data from Phase II Study in,Alzheimer's Disease at International Conference on Prevention of,Dementia

xtension rapidly showed significant improvement in memory and cognition, while AC-1202 appeared to have a disease stabilizing effect on subjects expressing the ApoE4 genotype (ApoE4(-)). Regardless of genotype, all subjects who remained on AC- 1202 for all nine months of the study showed very little disease progression, declining only 0.8 points below baseline in ADAS-Cog scores in contrast to the 5.4-point decline observed in placebo subjects extrapolated to nine months.

"The significant and rapid cognitive improvements observed in ApoE4(-) patients support the efficacy observed in our Phase IIa study," said Dr. Lauren Costantini, Accera's vice president of clinical development. "It also provides further evidence of the link between Alzheimer's disease and neuronal hypometabolism," she added, referring to AC-1202's novel mechanism of action.

AC-1202 continued to be well tolerated by subjects in the open-label extension study, providing an additional six months of safety data. The incidence of treatment-related gastrointestinal side effects was similar to that of other AD drugs in the double-blind phase of the study, but a reformulated version of AC-1202 used in the open-label extension study greatly reduced these side effects.

"The excellent safety profile of AC-1202 in addition to its efficacy on top of existing AD drugs makes it a strong candidate for a co-therapeutic approach to the treatment of Alzheimer's disease," said Dr. Steve Orndorff.

Open-label results were highlighted in a "Late Breaking News" press conference today at 1:30 p.m. (EDT) by the Alzheimer's Association. The 2nd Annual International Conference on Prevention of Dementia, a multidisciplinary forum for professionals from the fields of bench research, drug discovery, medicine, care and public policy, is hosted by the Alzheimer's Association, the leading voluntary health organization in Alzheimer care, support and research.

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