Results Feature Favorable Safety, Maximum Tolerated Dose, Positive Dose Response as well as Positive Unexpected Therapeutic Response Events
NEW YORK, NY – July 24, 2016 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, today announced data from the first of two posters at the Alzheimer’s Association International Conference® (AAIC) 2016.
Data presented in the first poster highlights the evaluation of a maximum tolerated dose (MTD) of ANAVEX 2-73 as primary endpoint of the Phase 2a study in mild-to-moderate Alzheimer’s patients, as well as additional clinical safety data and positive unexpected therapeutic response events, such as improved mood, improved social engagement and increased independent activities through 31 weeks. The second poster will present efficacy data through 31 weeks.
“ANAVEX 2-73 data presented today is prerequisite information in order to progress into Phase 2/3 placebo controlled studies,” said Professor Harald Hampel, MD, PhD, Professor and AXA Research Fund Chair at Sorbonne Universities’ Pierre and Marie Curie University (UPMC), Paris, France and member of Anavex’s Scientific Advisory Board. “ANAVEX 2-73’s specific molecular biology, combined with its observed favorable safety and tolerability profile makes it a very interesting candidate to explore in further clinical trials of different neurological diseases.”
Dose-response analysis indicates a cognitive benefit associated with ANAVEX 2-73 (both MMSE and EEG/ERP improved significantly at 5 weeks of treatment). Low-High dose was statistically significant to affect MMSE-Δ and ERP-Δ scores with MMSE-Δ (p=0.0285) and ERP-Δ (p=0.0168), respectively.
ANAVEX 2-73 continues to demonstrate a favorable adverse event (AE) profile through 31 weeks in a patient population of elderly Alzheimer’s patients with varying degrees of physical fragility. The most common side effects across all AE categories tended to be of mild severity grade 1, and were resolved with dose reductions that were anticipated within the adaptive design of the study protocol. The poster presentation is available on the publications page of the Anavex website.
“We are encouraged by these new results, which provide us with valuable knowledge about ANAVEX 2-73 and allow us to proceed methodically in the development of ANAVEX 2-73,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex.
About the ANAVEX 2-73 Phase 2a Study
The multi-center Phase 2a clinical trial of 32 mild-to-moderate Alzheimer’s patients consists of two parts. In PART A ANAVEX 2-73 is administered during five weeks in a randomized, open-label study with adaptive design. PART B is continued administration of ANAVEX 2-73 in a voluntary 52-week open-label extension, followed by an additional voluntary 104-week extension study, allowing for the gathering of safety data for ANAVEX 2-73 cumulatively over three years.
The primary endpoint of the Phase 2a trial is to establish safety, tolerability and maximum tolerated dose (MTD) of ANAVEX 2-73. Secondary endpoints includes exploratory cognitive as well as functional measures using Mini Mental State Examination (MMSE) and evaluation of Alzheimer’s Disease Co-operative Study – Activities of Daily Living Inventory (ADCS-ADL), respectively.
Additional information regarding the ongoing Phase 2a clinical study is available from the U.S. National Institutes of Health (NIH) clinical trials database at www.clinicaltrials.gov.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer. Anavex’s lead drug candidate, ANAVEX 2-73, is 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 safety 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 animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. The Michael J. Fox Foundation (MJFF) for Parkinson’s Research has awarded Anavex a research grant to develop ANAVEX 2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEX 2-73 into a Parkinson’s disease clinical trial. ANAVEX 3-71, also targeting sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease modifications against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also with beneficial effects on neuroinflammation and mitochondrial dysfunctions. 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.
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