Anavex Life Sciences Corp., a clinical stage biopharmaceutical company, engages in the development of drug candidates for the treatment of central nervous system diseases. The company’s lead drug candidate is ANAVEX 2-73, which has completed Phase 2a clinical trial for Alzheimer’s disease; and preclinical clinical trials to treat Parkinson’s disease, Rett syndrome, epilepsy, infantile spasms, Fragile X syndrome, Angelman syndrome, multiple sclerosis, and tuberous sclerosis. It is also developing ANAVEX 3-71 to treat Alzheimer’s disease; ANAVEX 1-41, a sigma-1 agonist; ANAVEX 1066, a mixed sigma-1/sigma-2 ligand for the potential treatment of neuropathic and visceral pain; and ANAVEX 1037 to treat prostate and pancreatic cancer. The company was founded in 2006 and is based in New York, New York.

Anavex utilizes precision genetic medicine to treat severe and devastating neurological disorders and
is focusing on rare diseases with no available therapy (Rett syndrome) and high risk CNS patient populations (Parkinson’s Disease, Alzheimer’s Disease)

Anavex Life Sciences Reaches 50% Enrollment Threshold in ANAVEX®2-73 Parkinson’s Disease Dementia (PDD) Phase 2 Study Ahead of Schedule

NEW YORK – March 11, 2019 – 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 (AD), Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today announced it has reached the 50% patient enrollment threshold of its multicenter, Phase 2 clinical study evaluating ANAVEX®2-73 in Parkinson’s Disease Dementia (PDD) ahead of schedule.

The study is expected to enroll approximately 120 patients, randomized 1:1:1 to two different ANAVEX®2-73 doses or placebo. 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 the 14-week study.[1]ANAVEX®2-73 Phase 2a Alzheimer’s disease study previously demonstrated dose dependent improvement in exploratory endpoint of cognition (MMSE) within 5 weeks.

Christopher U Missling, PhD, President and Chief Executive Officer of Anavex, said: “We are encouraged by the rate of patient enrollment in this Phase 2 study and the potential for ANAVEX®2-73 to become a therapy for this unmet need given that up to 80% of Parkinson’s patients develop dementia.”

 

About Parkinson’s Disease 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 up 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.[2]

About ANAVEX®2-73

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.

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