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Anavex Presents Positive Initial Phase 2a Study Data With ANAVEX 2-73 Showing Early Evidence of Improving Cognition in Patients With Alzheimer’s Disease at AAIC 2015
NEW YORK, July 22, 2015 — Anavex Life Sciences Corp. (“Anavex” or the “Company”) (OTCQX:AVXL) today announced initial positive cognitive data for ANAVEX 2-73, the Company’s lead investigational oral treatment for Alzheimer’s targeting sigma-1 and muscarinic receptors, which is believed to reduce protein misfolding including reduction of beta amyloid, tau and inflammation. Cognitive EEG/ERP P300 data, a real-time physiological measure of cognitive processes with demonstrated sensitivity to Alzheimer’s disease, is being presented today for the first 12 of 32 mild-to-moderate Alzheimer’s patients in the ongoing ANAVEX 2-73 Phase 2a clinical trial at AAIC 2015 in Washington, DC.
ANAVEX 2-73 showed in 83 percent (10/12) of patients positive cognitive effects during PART A of the study, which consists of a 36-day on-off-on not-yet-optimized dosing regimen to assess bioavailability. At day 36, the amplitude of the cognitive EEG/ERP biomarker P300 increased 38 percent from baseline. Published data suggests that a 38 percent increase is approximately 4 times higher than donepezil (Aricept®), the current standard of care, in the same timeframe.
Preliminary measured Mini Mental State Examination (MMSE) and Cogstate scale changes are consistent with the observed trend of the cognitive EEG/ERP effect. The safety profile of ANAVEX 2-73 during Phase 2a appears consistent with the Phase 1 data; additional clinical data of the trial will be presented at future medical meetings.
“This is the first time the investigational drug ANAVEX 2-73 has been administered to Alzheimer’s patients. In addition to the positive EEG/ERP P300 biomarker signal, the feedback we’ve had so far is that patients and care providers have noticed both cognitive and functional improvement, increased alertness, improvement in activities of daily living, greater organization and a requirement for less prompting,” said study’s principal investigator Dr. Stephen Macfarlane, FRANZCP, Associate Professor and Director of Aged Psychiatry at The Alfred Hospital. “Subsequent to the positive initial feedback, we are applying to expand the extension period from 26 weeks to 52 weeks at the request of the participants.”
“We are cautiously optimistic given the encouraging feedback and the preliminary cognitive data. We look forward to the full ANAVEX 2-73 Phase 2a trial results,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “As of today, we have enrolled two-thirds of the patients. We expect the trial to be fully enrolled and to have PART A completed by the end of the year.”
The poster entitled “New Exploratory Alzheimer’s Drug ANAVEX 2-73 Changes in Electrophysiological Markers in Alzheimer’s Disease – First Patient Data from an ongoing Phase 2a Study in mild-to-moderate Alzheimer’s Patients” was co-authored by Steve Macfarlane, Marco Cecchi, Dennis Moore, Anastasios Zografidis and Christopher Missling and is available on the publications page of the Anavex website.
About the ANAVEX 2-73 Phase 2a Study
The ongoing, multicenter Phase 2a adaptive trial of ANAVEX 2-73 in both male and female mild-to-moderate Alzheimer’s patients seeks to enroll 32 patients. It started in January 2015 and the first 12 patients, most who are also taking donepezil, have completed PART A of the two-part trial. Lasting up to 36 days for each patient, PART A is a simple randomized, open-label, two-period trial with an on-off-on not-yet-optimized dosing regimen to assess bioavailability, and cross-over between oral (30mg/50mg) and IV (3mg/5mg) administration. Event-related potentials (EEG/ERP) are used to assess cognitive effects and optimize dosing of ANAVEX 2-73. PART B is an open-label extension for an additional 26 weeks, with daily oral dosing so as to establish a longer drug effect.
The primary endpoint of the Phase 2a trial is evaluation of the maximum tolerated dose of ANAVEX 2-73, which had shown potential in preclinical studies to prevent, halt and/or reverse the course of the disease. Secondary endpoints are dose response, bioavailability, exploratory cognitive effects using electroencephalographic (EEG) activity, including event-related potentials (EEG/ERP), Mini Mental State Examination (MMSE), Cogstate and evaluation of ADSC-ADL and add-on therapy to donepezil, the current standard of care, which represents ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept®).
Additional information regarding the trial is available from the U.S. National Institutes of Health (NIH) clinical trials database at www.clinicaltrials.gov.
About Alzheimer’s Disease
Today, Alzheimer’s disease remains the largest unmet medical need in neurology. More than 25 million people are currently diagnosed with Alzheimer’s, with the associated cost of care estimated to exceed $200 billion annually. By 2050, 100 million people are expected to be living with the disease. Alzheimer’s disease is a neurological disorder generally characterized by memory loss and cognitive decline. A neurodegenerative form of dementia, the disease begins with mild symptoms and becomes progressively worse.
The Alzheimer’s Association International Conference® (AAIC) is the world’s largest forum for the dementia research community. International investigators, clinicians and care providers gather annually to share the latest study results, theories and discoveries to bring the world closer to breakthroughs in dementia science. As part of the Alzheimer’s Association’s research program, AAIC serves as a catalyst for generating new knowledge about dementia and fostering a vital, collegial research community.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (OTCQX:AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel drug candidates to treat central nervous system (CNS) diseases and various types of cancer. Anavex’s lead drug candidates, ANAVEX 2-73 and ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept®), are currently in a Phase 2a clinical trial for Alzheimer’s disease. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean data profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in convulsive epileptic animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. The drug combination ANAVEX PLUS produced up to 80% greater reversal of memory loss in Alzheimer’s disease models versus when the drugs were used individually. Further information is available at www.anavex.com.
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.