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Accera Presents New Pharmacogenomics Data on Medical Food Product for Alzheimer's Disease

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By Turna Ray

Axona, an investigational compound for Alzheimer's disease being developed by Accera, has been shown in clinical trials to improve symptoms in patients with certain variants of the APOE gene and insulin degrading enzyme gene, the company said this week.

Accera presented data at the International Conference on Alzheimer's Disease this week in Vienna, showing that the ketogenic compound Axona "demonstrated significant improvement" in patients who lacked the epsilon 4 variant of the APOE gene and the C/C polymorphism in IDE 7.

"New data from the company's previously completed double-blind, placebo-controlled trial in patients with mild-to-moderate Alzheimer's disease demonstrates an interaction between [these] two genetic markers that strongly influence the therapeutic response in patients," Accera said in a statement announcing the study data.

Previously, in a study conducted with the University of Washington in 2002, Accera researchers used gene sequencing to determine Axona's efficacy in a subgroup of patients lacking the APOE4 genotype [see PGx Reporter 11-07-2007].

In the latest analysis, researchers found that Axona-treated patients who lacked both APOE4 and IDE7 (C/C), had "more pronounced improvements in their Alzheimer's Disease Assessment Scale-Cognitive scores compared to placebo" during various assessment points in the study, when compared to placebo.

In this subpopulation, at day 45 the improvement in ADAS-cog score was 4.18 (p=0.0004), while at Day 90 the difference was 4.73 (p=0.001), the company said.

"Numerous clinical studies have demonstrated that modest improvements in ADAS-cog scores — on the order of 2 to 3 points over the course of a year — have been associated with significant cost reductions in overall managed care expenditures," Accera said in a statement.

Researchers also found a difference in cognitive test scores of 3.27 two weeks after termination of AC-1202 treatment (p=0.034). "This finding suggests that daily administration of AC-1202 may produce lasting effects in those patients with this combination of genotypic markers," Accera said.

According to Accera, the combination of the E4(-); IDE_7(C/C)(-) genotype is prevalent in approximately 40 percent of Alzheimer's disease patients.

"This is the first scientific report of the role of IDE and its interaction with APOE on therapeutic efficacy in Alzheimer's disease patients," Samuel Henderson, research director at Accera, said in a statement.

Axona is a prescription-only medical food for managing the metabolic processes associated with mild-to-moderate Alzheimer's disease. Previously Accera was calling the drug Ketasyn.

As a medical food product, Axona is regulated by the US Food and Drug Administration in terms of labeling, manufacturing standards, and development. However, it does not undergo the same approval process as a traditional pharmaceutical product.

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