Accera, Inc. Appoints Dr. Thomas Werner President & CEO and Announces FDA Acceptance of IND Application for AC-1204 for Mild-to-Moderate Alzheimer's Disease
October 5, 2010
Broomfield, CO, October 5, 2010 – Accera, Inc., a medical research and development company delivering breakthrough therapies for serious diseases such as Alzheimer's disease (AD), announced today that Thomas Werner, Ph.D., has been appointed President and CEO. Concurrently with Dr. Werner's appointment, the U.S. Food and Drug Administration (FDA) has accepted Accera's Investigational New Drug (IND) application to conduct a phase 2-3 clinical study in patients with mild-to-moderate AD with its product AC-1204.
Dr. Werner was elected to Accera's board of directors in March 2009. Prior to his election, he was the managing director and senior vice president of GlaxoSmithKline (GSK) in Germany and had served as CEO of the GSK Foundation until early 2009. Dr. Werner was instrumental in the development of successful growth strategies for the German subsidiaries of GSK and Bristol-Myers Squibb. Under his leadership, the ACE inhibitor captopril became the largest selling pharmaceutical product in Germany, and the asthma drug Viani™ grew to become one of the leading pharmaceutical products in Germany.
Dr. Werner cofounded the Genetic Research Center, a joint venture with the Max Planck Institute for Psychiatry and the Ludwig-Maximilians-University, both in Munich. Dr. Werner earned his Ph.D. in chemistry at the University of Göttingen in Germany.
"We are delighted to appoint Dr. Werner as Accera's president and CEO," said Claude H. Nash, Ph.D., Chairman of Accera's Board of Directors. "As Accera continues expanding its commercialization efforts for Axona® and initiates clinical trials with AC-1204, Dr. Werner's leadership will maximize Accera's development of therapeutic alternatives for Alzheimer's disease."
Based in part on available clinical data associated with, Axona/AC-1202, Accera will forego conducting the traditional phase 1 dose-escalation trial of AC-1204 and proceed directly to a phase 2-3 study. Referred to as the ALERT Protocol (AC-1204 Long-Term Efficacy Response Trial), the planned trial will be a six month, double-blind, randomized, placebo-controlled, parallel-group study to investigate the effects of daily administration of AC-1204 in subjects with mild to moderate AD. Approximately 400 study subjects are anticipated to enroll in as many as 30 clinical sites within the U.S. The efficacy of AC-1204 versus placebo will be measured by two primary outcomes: changes from baseline test scores in the Alzheimer's Disease Assessment Scale – Cognitive subscale (ADAS-Cog) and the Clinician's Interview-Based Impression of Change Plus (CIBIC-plus). These tests have been established as validated measurements of efficacy accepted by FDA for approval of other medications for AD.
Accera has completed four clinical trials with similar compounds in elderly normal volunteers and in patients with memory impairment or mild-to-moderate AD. In these trials, patients with mild-to-moderate AD receiving Axona (AC-1202) for up to 90 days experienced cognitive improvement compared with placebo. These treatment effects were notably significant among patients who were not carriers of the apolipoprotein E4 allele (APOE4), a genetic risk factor associated with a higher probability of developing AD. Approximately 50% of individuals diagnosed with probable AD are estimated to be APOE4 positive. Peer-reviewed results were published in Nutrition & Metabolism in August 2009 in the article entitled "Study of the ketogenic agent AC-1202 in mild to moderate Alzheimer's disease: a randomized, double-blind, placebo-controlled, multicenter trial." Axona (AC-1202) is currently commercially available in the US as a prescription medical food product.
Like Axona, AC-1204 increases production of ketone bodies, which can serve as an alternative fuel for the brain in AD patients suffering from glucose hypometabolism. Numerous studies have shown that an early feature of AD is region-specific declines in cerebral glucose metabolism. One strategy to treat this condition has been to supplement the brain's normal glucose supply with ketone bodies.
"Accera is in a period of significant growth in both the commercialization of Axona and development of clinical trials with AC-1204. I look forward to leading the Company in both efforts," said Dr. Werner. "The IND acceptance for AC-1204 represents a further validation of Accera's methods, research and commitment to advancing novel therapeutic alternatives for Alzheimer's disease. We expect the ALERT study will further demonstrate the long-term benefits of Accera's approach to Alzheimer's."
AC-1204 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 glucose metabolism. This approach has been shown to safely improve cognitive function and memory in AD patients and in pre-clinical animal models of dementia.
Axona is a prescription-only medical food intended for the clinical dietary management of the metabolic processes associated with mild-to-moderate Alzheimer's disease. For more information about Axona, please visit www.about-axona.com or ask your physician.