Results Demonstrate Significant Reversal in Cognitive Deficit, Inflammation and Alzheimer’s-like Amyloid Pathology
NEW YORK, NY – March 14, 2016 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, today announced positive preclinical data on sigma-1 agonist ANAVEX 3-71 (formerly AF710B). The results show a statistically significant reduction in the rate of cognitive deficit, amyloid beta pathology and inflammation with the administration of ANAVEX 3-71.
The poster, titled “AF710B, a concomitant activator of M1 muscarinic and sigma-1 receptors: possible disease-modifying properties in McGill-R-Thy1-APP rats,” was presented at the 14th International Symposium on Advances in Alzheimer’s Therapy (AAT) from March 9-12, 2016. The study examined the responses of ANAVEX 3-71 in aged transgenic McGill-R-Thy1-APP rats and wild-type rats dosed with 10 micrograms/kg/day ANAVEX 3-71. Both types of rats (12-14 months of age) were given either oral ANAVEX 3-71 or a placebo control for 4.5 months and then subjected to a washout period for five weeks. Following the washout, a number of cognitive tests were performed with the rats, now 18-20 months of age.
Despite the treatment interruption, the effects of administration of ANAVEX 3-71 resulted in a statistically significant improvement in cognitive function assessed by Novel Object Recognition and Morris Water Maze. In the Novel Object Recognition task, ANAVEX 3-71 completely reversed the deficit observed in transgenic rats (p<0.001), which performed similarly to wild-type rats. In the Morris Water Maze task, treated transgenic rats also fully recovered to perform at a level comparable to that of wild-type rats (p<0.001). A statistically significant reduction (p<0.05) in two measures of amyloid-beta pathology commonly associated with Alzheimer’s disease was also observed in comparison to control. Additionally, ANAVEX 3-71 demonstrated anti-inflammatory properties, compared to control (p<0.05), which may also have relevance in Alzheimer’s disease.
“The data from this study further validates the belief that ANAVEX 3-71 may have significant utility in the treatment of Alzheimer’s disease. This study examined potential long-term effect of the compound following a five-week hiatus from dosing, which suggests the potential for disease modification – something we have not often seen,” said Professor Claudio Cuello, Professor at the Department of Pharmacology and Therapeutics, McGill University, Montreal, Canada and main author of the study. “This preclinical study provides a variety of improvements in disease progression, including anti-inflammatory properties in aged rats, a test subject that more closely reflects the disease model in Alzheimer’s patients and which we hope to see repeated in human subjects.”
“This body of data of ANAVEX 3-71, in addition to our clinical candidate, ANAVEX 2-73 suggests that our approach of targeting the complex pathology of Alzheimer’s disease further upstream may have the potential to address the areas of unmet need for individuals living with this disease,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex.
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 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 convulsive epileptic 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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