Anavex Life Sciences Receives Approval to Initiate Phase 2 Clinical Trial of ANAVEX®2-73 for the Treatment of Parkinson’s Disease Dementia
Primary Endpoint Cognition with Secondary Endpoints Parkinsonian Motor Symptoms and Sleep Function during 14-Week Study
NEW YORK – July 9, 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, today announced that the Company has received approval from the Spanish Agency for Medicinal Products and Medical Devices (AEMPS), to initiate its Phase 2, double-blind, placebo-controlled 14-week trial of the safety and efficacy of ANAVEX®2-73 for the treatment of Parkinson’s disease dementia (PDD). The Phase 2 study is scheduled to initiate enrollment of approximately 120 patients, randomized 1:1:1 to two different ANAVEX®2-73 doses or placebo, within the next few months, in up to 24 clinical study sites.
Professor Dag Aarsland, MD, Head of Department of Old Age Psychiatry at the Institute of Psychiatry, Psychology and Neuroscience at King’s College London commented: “Since as many as 80 percent of people with Parkinson’s will experience Parkinson’s disease dementia and treatment options are limited, this study is using the latest generation of diagnostic and treatment developments in Parkinson’s disease dementia and I am looking forward to a potential contribution to the future development of this significant unmet need.”
The Company ‘s trial design for the Phase 2 program in PDD includes genomic, precision medicine-based biomarkers identified from patients previously treated with ANAVEX®2-73. This novel approach has informed clinical trial designs and is expected to yield insight as to potential responders, and to enrich future regulatory submissions.
“We are excited about the approval to initiate the Phase 2 study of ANAVEX®2-73 for the treatment of Parkinson’s disease dementia, which will focus on the effect of ANAVEX®2-73 on both the cognitive and motor impairment of Parkinson’s disease,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “We continue leveraging our precision medicine approach to drug development to provide intelligence beyond many traditional neurology trials to disease areas with high unmet needs.”
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, 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 to develop ANAVEX®2-73 for the treatment of Parkinson’s disease. The grant fully funded a preclinical study. 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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