Anavex Life Sciences to Initiate Phase 2 Study of ANAVEX®2-73 in Parkinson’s Disease Dementia and Provides Clinical Study Update for ANAVEX®2-73 in Rett Syndrome
NEW YORK – April 17, 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 the Company is planning to initiate a Phase 2 clinical trial of lead candidate ANAVEX®2-73 in Parkinson’s Disease Dementia (PDD).
“As many as 80 percent of people with Parkinson’s will experience Parkinson’s disease dementia and treatment options are limited,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “We are excited to progress our program to Phase 2, with a focus on the many patients with Parkinson’s disease dementia, and we remain focused on the discovery and development of potential treatments for neurological diseases with unmet needs, including Alzheimer’s disease and Rett syndrome.”
There is a significant unmet medical need in the development of Parkinson’s disease therapies that could be addressed by Anavex’s novel, sigma-1 receptor agonist, ANAVEX®2-73, in Parkinson’s disease patients with dementia, or PDD. The Company is moving forward with a Phase 2 trial with ANAVEX®2-73 in PDD, which will study the effect of the compound on both the cognitive and motor impairment of Parkinson’s disease. The double-blind, randomized, placebo-controlled Phase 2 PDD study has been submitted to regulatory authorities in Europe, and pending approval, the Company plans to initiate this clinical trial H2 2018. Additional protocol details will be shared at that point.
The earlier studies of ANAVEX®2-73 in a disease modifying model of Parkinson’s disease were funded by The Michael J. Fox Foundation for Parkinson’s Research.
In addition, an updated investigational new drug application (IND) for the double-blind, randomized, placebo-controlled ANAVEX®2-73 Phase 2 study in Rett syndrome was submitted to the FDA in the first quarter of 2018. The Company is currently in dialogue with the agency and anticipates potential initiation of this clinical trial H2 2018. Additional protocol details will be shared at that point.
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.
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, which could justify moving ANAVEX®2-73 into a Parkinson’s disease clinical trial. 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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 Source: www.alz.org/dementia/parkinsons-disease-symptoms