Study will incorporate genomic precision medicine ANAVEX®2-73-specific biomarkers
NEW YORK – October 30, 2018
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, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today announced that it has enrolled the first patient in its Phase 2 double-blind, randomized, placebo-controlled, 14-week safety and efficacy trial of ANAVEX®2-73 for the treatment of Parkinson’s disease dementia (PDD). The Phase 2 study will enroll approximately 120 patients, randomized 1:1:1 to two different ANAVEX®2-73 doses or placebo.
“Parkinson’s disease is an already prevalent disease among older individuals that is poised to become a much greater public health problem around the globe in the coming decades and is now appreciated commonly to cause cognitive impairment, including dementia, and behavioral changes,” commented Professor Jaime Kulisevsky, MD, PhD Vice Dean Faculty of Medicine and Full Professor of Neurology at the Autonomous University of Barcelona and Director of the Movement Disorders Unit of the Sant Pau Hospital in Barcelona, Spain, and Principal Investigator of the Phase 2 study.
The ANAVEX®2-73 Phase 2 study design incorporates genomic precision medicine biomarkers identified in the ANAVEX®2-73 Phase 2a AD study. Primary and secondary endpoints will assess safety and both cognition and Parkinsonian motor symptoms and sleep function during 14-week study. ANAVEX®2-73 Phase 2a Alzheimer’s disease study previously demonstrated dose dependent improvement in exploratory endpoint of cognition (MMSE) within 5 weeks.
“We are very pleased to initiate our first patient enrollment into the Parkinson’s disease dementia Phase 2 study of ANAVEX®2-73,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “This is an important step toward achieving clinical data for the second indication initiating this year for ANAVEX®2-73 also incorporating genomic precision medicine biomarkers.”
About the ANAVEX®2-73 Parkinson’s Disease Dementia Clinical Phase 2 Study
For patients within Spain who wish to be considered for participation in this study, please visit the Ethics Committee (EC)-approved website, www.pddtrial.com. Patients or caregivers interested in the study can download a simple screening questionnaire to facilitate their discussion with their local physician.
About Parkinson’s disease with dementia (PDD)
Parkinson’s disease is a fairly common neurological disorder in older adults, estimated to affect nearly 2 percent of those older than age 65. The Parkinson’s Foundation estimates that 1 million Americans have Parkinson’s disease. It is estimated that 50 to 80 percent of those with Parkinson’s disease eventually experience Parkinson’s disease dementia. The brain changes caused by Parkinson’s disease begin in a region that plays a key role in movement. As Parkinson’s brain changes gradually spread, they often begin to affect mental functions, including memory and the ability to pay attention, make sound judgments and plan the steps needed to complete a task.
 Source: www.alz.org/dementia/parkinsons-disease-symptoms
ANAVEX®2-73 activates the Sigma-1 receptor (S1R) protein, which serves as a molecular chaperone and functional modulator involved in restoring homeostasis. In a Phase 2a Alzheimer’s disease (AD) study, ANAVEX®2-73 has shown dose dependent improvement in exploratory endpoints of cognition (MMSE) and activities of daily living (ADCS-ADL). Full genomic analysis of ANAVEX®2-73 Phase 2a AD patients was performed. The ANAVEX®2-73 Phase 2 PDD study design includes genomic biomarkers identified in the ANAVEX®2-73 Phase 2a AD study. Studies of ANAVEX®2-73 in a disease modifying model of Parkinson’s disease indicates that ANAVEX®2-73 is well tolerated, induces significant motor recovery (p<0.05), induces neurohistological restoration (p<0.05) and reduces microglial activation (p<0.05), a potential biomarker of Parkinson’s disease. Behavioral patterns were completely normal, meaning no signs of either dystonia or stereotypic behaviors were detected in animals receiving the treatment. These studies were funded by The Michael J. Fox Foundation for Parkinson’s Research.
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, Rett syndrome and other central nervous system (CNS) diseases, pain and various types of cancer. Anavex’s lead drug candidate, ANAVEX®2-73, recently completed a successful Phase 2a clinical trial for Alzheimer’s disease. ANAVEX®2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson’s Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson’s disease. ANAVEX®3-71, which targets sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer’s disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on neuroinflammation and mitochondrial dysfunction. Further information is available at www.anavex.com. You can also connect with the company on Twitter, Facebook and LinkedIn.
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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