GlobeNewswire Inc | Aug 19, 2020 07:00AM EDT

August 19, 2020

NEW YORK, Aug. 19, 2020 (GLOBE NEWSWIRE) -- 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 Alzheimers disease, Parkinsons disease, Rett syndrome and other central nervous system (CNS) diseases, today announced that the Shake It Up Foundation for Parkinsons Research and its international partners has committed to invest into Anavex up to 50% of the costs of a disease modifying clinical study to develop ANAVEX2-73 (blarcamesine) for the disease modifying treatment of Parkinsons disease.

Shake It Up is proud and excited to support research like this that may create opportunities for breakthroughs thatcouldbe a game-changer for people with Parkinsons, said Clyde Campbell, Founder and CEO of the Shake It Up Foundation. The potential of a disease modifying treatment for Parkinsons disease could be a very promising next step in further human testing of ANAVEX2-73 (blarcamesine), in which the therapy goes through a rigorous process to determine whether it is safe, tolerable and efficacious.

We see this collaboration as an important step in our global effort to expedite the development of ANAVEX2-73 (blarcamesine) and to evaluate ANAVEX2-73 (blarcamesine) for Parkinsons disease as a potential disease modifying agent. Shake It Up Foundation shares our commitment to move rapidly to address the unmet need for treatments for Parkinsons disease, and brings deep experience and an extensive network within the Parkinsons community, said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex.

The planned clinical study will use a convenient, once-daily oral ANAVEX2-73 (blarcamesine) formulation to confirm the previously established potential disease modifying features of ANAVEX2-73 (blarcamesine) in an animal model of Parkinsons disease. Safety and efficacy will be investigated in an appropriately powered placebo-controlled clinical study of Parkinsons disease patients over at least 48-weeks including ANAVEX2-73-specific precision medicine biomarkers. All patients who participate in the study will be eligible to receive ANAVEX2-73 (blarcamesine) under a voluntary open label extension protocol.

About Shake It Up Australia Foundation for Parkinsons Research

Shake It Up Australia Foundation for Parkinsons Research is a not-for-profit organization established in 2011 and in partnership with The Michael J. Fox Foundation (MJFF) promotes and funds Parkinsons disease research in Australia aimed at better treatments and ultimately a cure. Further information is available at https://shakeitup.org.au/.

About Parkinsons Disease

Parkinsons disease is a chronic and progressive neurological disorder that is characterized by well-known motor symptoms including tremors, stiffness of limbs, slowness of movements, and difficulties with posture and balance, as well as by non-motor symptoms. It is the second most common neurological disorder and approximately one million people in the United States, and from four to six million people worldwide, live with this disease. Parkinsons disease is more common in people over 60 years of age and its prevalence is expected to increase significantly as the average age of the population increases. Current Parkinsons treatments are only effective in managing symptoms of the disease, mainly through the use of levodopa and dopamine agonists. As the disease progresses and dopaminergic neurons continue to be lost, these drugs eventually become less effective at treating the symptoms.

About ANAVEX2-73 (blarcamesine)

ANAVEX2-73 (blarcamesine) activates the Sigma-1 receptor (S1R) protein, which serves as a molecular chaperone and functional modulator involved in restoring homeostasis. In a Phase 2a Alzheimers disease (AD) study, ANAVEX2-73 (blarcamesine) has shown dose dependent improvement in exploratory endpoints of cognition (MMSE) and activities of daily living (ADCS-ADL). Full genomic analysis of ANAVEX2-73 (blarcamesine) Phase 2a AD patients was performed. The ANAVEX2-73 (blarcamesine) Phase 2 Parkinsons disease dementia (PDD) study design includes genomic biomarkers identified in the ANAVEX2-73 (blarcamesine) Phase 2a AD study. Studies of ANAVEX2-73 (blarcamesine) in a disease modifying model of Parkinsons disease indicates that ANAVEX2-73 (blarcamesine) 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 Parkinsons 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 Parkinsons 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 disorders including Alzheimers disease, Parkinsons disease, Rett syndrome and other central nervous system (CNS) diseases, pain and various types of cancer. Anavexs lead drug candidate, ANAVEX2-73 (blarcamesine), recently completed a successful Phase 2a clinical trial for Alzheimers disease. ANAVEX2-73 (blarcamesine) 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 Alzheimers disease. ANAVEX2-73 (blarcamesine) 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 Parkinsons Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX2-73 (blarcamesine) for the treatment of Parkinsons disease. ANAVEX3-71, which targets sigma-1 and muscarinic receptors, is a promising preclinical drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimers disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies. In preclinical trials, ANAVEX3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com. You can also connect with the company on Twitter,Facebook and LinkedIn.

Forward-Looking Statements

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 Companys 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.

For Further Information:

Anavex Life Sciences Corp.Research & Business DevelopmentToll-free: 1-844-689-3939Email: info@anavex.com

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