Accera Announces Peer-Reviewed Publication of the Results of its 90-day Clinical Study of AC-1202 (Axona™) in Mild to Moderate Alzheimer's Disease
August 12, 2009
AC-1202 rapidly and safely improved cognition and short term memory
Broomfield, CO, August 12, 2009 – Accera, Inc., a biotechnology company delivering breakthrough therapies in central nervous system (CNS) disorders, announced today publication of a scientific paper in the peer-reviewed journal Nutrition & Metabolism. The paper, entitled "Study of the ketogenic agent AC-1202 in mild to moderate Alzheimer's disease: a randomized, double-blind, placebo-controlled, multicenter trial" suggests that daily administration of AC-1202 (Axona™) can help improve cognition and memory in patients with mild-to-moderate Alzheimer's disease (AD).
"Accera has taken a novel approach to Alzheimer's therapy with the development of Axona," said Samuel Henderson, Ph.D., executive director of research at Accera and lead author of the paper. "Publication of our findings confirms our earlier pre-clinical and clinical findings which show that using ketone bodies can be an effective and safe method to approach this devastating disease."
Alzheimer's disease is characterized by early and region-specific declines in the brain's ability to metabolize glucose, its main fuel source. Prior clinical evidence suggests that ketones can serve as an alternative energy source for the brain during glucose deprivation. Axona, which was launched as a prescription medical food product in the US in March 2009, is a proprietary formulation of a pharmaceutical-grade medium chain triglyceride (AC-1202) designed to safely elevate serum ketone bodies, thus providing an alternative energy source for the brain. In this Phase IIb trial, AC-1202 was used to determine whether chronic induction of mild ketosis in patients with probable Alzheimer's disease could improve cognition and short term memory performance.
The 90-day, randomized, double-blind, placebo-controlled, parallel-group study, evaluated the effect of daily dosing of AC-1202 in patients diagnosed with mild-to-moderate Alzheimer's disease. The study was conducted in 152 patients at 23 clinical sites throughout the United States. The study examined the effects of AC-1202 on performance in the Alzheimer's Disease Assessment Scale – Cognitive subscale (ADAS-Cog). Notably, participants in the study were allowed to remain on their current Alzheimer's disease medications and did not have to alter their diets in any way. Approximately 80% of the participants were taking one or more Alzheimer's disease drugs.
Researchers found that AC-1202 was safe and produced a beneficial trend for the overall subject population and significant cognitive benefits in a predefined analysis of patients who did not carry the epsilon 4 (E4) variant of the apolipoprotein E gene (APOE4). Possession of an APOE4 allele is the major genetic risk factor for development of the most common form of Alzheimer's disease. In addition, there was a significant correlation between improvement in cognition and memory and amount of AC-1202 consumed by APOE4(-) patients, i.e., dosing compliance. This finding suggests that AC-1202 may offer a novel and effective genotype-specific strategy for Alzheimer's disease. Approximately 50% of the general Alzheimer's disease patient population is APOE4(-).
"The impressive safety and efficacy data provide positive validation for Accera's Axona (AC-1202)," said Steven H. Ferris, Ph.D., professor of psychiatry and director at New York University Alzheimer's Disease Center and Chairman of the Accera medical advisory board, who reviewed the clinical findings. "Now available, physicians can prescribe Axona to their Alzheimer's patients as an adjunctive therapy to their existing Alzheimer's medical protocol."
The full peer-reviewed paper may be downloaded at no charge at www.nutritionandmetabolism.com.
Axona is a first-in-class prescription medical food for the clinical dietary management of the metabolic processes associated with mild-to-moderate Alzheimer's disease. Axona targets the metabolic deficiencies and imbalances associated with Alzheimer's disease by providing ketone bodies as an alternative energy source for brain cells that have defective energy metabolism and can no longer utilize glucose. Axona has been shown to safely improve cognitive function and memory in AD patients and in pre-clinical animal models of dementia. With simple administration and once-a-day convenience, Axona is complementary to current Alzheimer's disease therapies. Axona is a medical food as defined by the Orphan Drug Act and is regulated by the Food and Drug Administration. For more information about Axona, please visit www.about-axona.com or ask your physician.