Axona Passes Two Clinical Studies
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Thessaloniki, Macedonia, Greece - Accera, Inc., a biotechnology company delivering breakthrough therapies in central nervous system diseases, announced data which showed that augmentation with ketone bodies significantly improved cognitive function in Alzheimer's disease (AD) patients.
An early feature of AD is region specific declines in cerebral glucose metabolism. One strategy has been to supplement the brain's normal glucose supply with ketone bodies. The company's data was drawn from two clinical studies which examined the cognitive effects of induced ketosis. In both acute and chronic dosing, AC-1202 (Axona®) significantly induced ketosis two hours after administration. Further analysis of the studies revealed that patients administered Axona® who lacked the epsilon 4 variant of the APOE gene (E4(-)), demonstrated significant improvement from baseline values in the Alzheimer’s Disease Assessment Scale-Cognitive (ADAS-Cog) and improvement compared to placebo. In the population of patients who were both APOE4(-) and dosage compliant, more pronounced improvements in ADAS-cog scores were observed at each assessment timepoint (Day 45 and Day 90). At Day 45 the improvement in ADAS-cog score relative to Placebo was 6.26 (p=0.001), while at Day 90 the difference was 5.33 (p=0.006). These improvements were remarkable in that they were seen in patients who were already taking prescription Alzheimer medications. Many clinicians consider an improvement greater than 4 points to be clinically significant.
Dr. Samuel Henderson, Vice President of Research, will present these findings at the 25th International Conference of Alzheimer's Disease International. “We firmly believe that addressing the significant decrease in cerebral glucose in Alzheimer's patients is essential in combating this devastating disease,” said Dr. Henderson. “ This pharmacogenomic finding provides both insight into the mechanism of ketone-based therapies for Alzheimer’s disease, and also allows for the identification of patients who may respond best to therapy.”
Dr. Henderson will present an oral presentation titled Ketone Bodies As a Therapeutic for Alzheimer's Disease during the “Future of Treatments and Diagnosis” session on Thursday, March 11 from 2-3:30 p.m. Eastern European Time in the Olympia Hall A of the Grand Hotel Palace Thessaloniki. The abstract for this presentation will be published in the conference program and abstracts handbook, which will be available to delegates at the conference or through this link:
http://www.adi2010.org/default.aspx?pageid=Abstracts
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About Accera, Inc.
Accera, Inc. is a privately held commercial-stage biotechnology company that developed and now markets Axona® in the US. Axona® is a prescription-only product intended for the clinical dietary management of the metabolic processes associated with mild-to-moderate Alzheimer's disease. Accera is engaged in the research, development and commercialization of other clinical applications for Axona® in acute and chronic neurodegenerative diseases. For more information about Accera, please visit www.accerapharma.com.
About Axona®
Axona® is a first-in-class prescription product 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. For more information about Axona®, please visit www.about-axona.com or ask your physician.
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