Accera Launches Axona™, First Medical Food Therapy to Help Manage Mild-to-Moderate Alzheimer's Disease
March 2, 2009
Broomfield, CO, March 2, 2009 – Accera, Inc., a biotechnology company delivering breakthrough therapies in central nervous system (CNS) diseases, today launched Axona™ in the United States for Alzheimer's disease (AD). Axona is a first-in-class medical food for the clinical dietary management of the metabolic processes associated with mild-to-moderate Alzheimer's. Dispensed by prescription, it targets the metabolic deficiencies and imbalances associated with AD by providing an alternative energy source for brain cells.
Axona represents a new approach to helping manage AD symptoms and has been shown in clinical trials to safely improve cognitive function and memory in patients diagnosed with mild-to-moderate AD.
"We are happy to have this new therapeutic approach to add to our management strategies for this terrible disease," said Jeffrey L. Cummings, M.D., Director, Mary S. Easton Center for Alzheimer's Disease Research at UCLA, and a consultant to Accera. "By approaching the disease in a new way, Axona addresses a metabolic abnormality of Alzheimer's disease that has not previously been examined. The goal of therapy is to optimize cognitive function. Axona is safe and can be used with other common therapies for Alzheimer's."
Alzheimer's disease is a progressive and fatal neurological disease characterized by a substantial decrease in the brain's ability to metabolize glucose, which is the brain's primary source of energy. Known as hypometabolism, this defect may contribute to both the clinical and pathological course of the disease. Axona targets the metabolic defects of glucose utilization in the brain by providing an alternative energy source. Axona is digested and metabolized by the liver to form ketone bodies, naturally occurring compounds produced by the body at low levels. These ketone bodies act as a secondary energy source for the brain to help maintain and improve cognitive function.
"It's a novel and effective approach to Alzheimer's disease," said Steve, Orndorff, Ph.D., founder and CEO, Accera, Inc. "Similar to how insulin helps diabetics, Axona supplements energy for the brain so that neurons can continue to function properly and patients can maintain cognition. As a company focused on developing new therapies for central nervous system disorders, we're very excited about Axona's potential to help the AD community."
Axona was evaluated in a double-blind, randomized, placebo-controlled study performed at multiple U.S. clinical centers in a population of 152 patients with probable mild-to-moderate Alzheimer's disease. Patients taking Axona demonstrated significant improvements in cognitive function by day 45 (as measured by the Alzheimer's Disease Assessment Scale-Cognitive subscale or ADAS-Cog score). These patients also maintained a slight improvement from baseline after 90 days of daily Axona administration, whereas the placebo group demonstrated a decline. In these trials Axona was demonstrated to be safe, effective and generally well-tolerated.
Axona is supplied as a powder formulation in individual packets. Contents should be mixed with water and consumed at breakfast. With simple administration and once-a-day convenience, Axona is complementary to current Alzheimer's therapies.
About Alzheimer's Disease
AD, the most common form of dementia, is a progressive and fatal disease for which there is no cure. It attacks the brain's nerve cells, resulting in loss of memory, executive function, thinking and language skills. According to recent data, every 71 seconds someone in America develops AD.
In the U.S., 5.2 million people are living with AD, and it has become the sixth leading cause of death. These numbers are expected to increase as the baby boomer generation ages and as medical technology continues to advance. In fact, it is estimated that 10 million U.S. baby boomers alive today will develop Alzheimer's disease. With the lack of innovative new medications, both patients and caregivers are seeking alternative therapies to improve quality of life.
About Medical Foods
A Medical Food is an FDA-regulated product, in a relatively new category of medical protocols defined by Congress as part of the Orphan Drug Act. A Medical Food is formulated to be consumed or administered orally under the supervision of a physician and is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. Medical Foods are often prescription products, but are different than drugs or dietary supplements (also called "nutraceuticals") in several aspects, such as their claims. Claims for both Medical Foods and drugs must be supported by solid laboratory and clinical data. Medical Food ingredients have Generally Recognized As Safe (GRAS) designation, the highest FDA standard of safety given to foods. Medical Foods, sometimes prescribed in addition to drugs, represent an entirely different scientific and medical approach to managing diseases.