Anavex Life Sciences Announces Commitment for Financial Investment by Shake It Up Foundation for Parkinson’s Research for Clinical Trial of ANAVEX®2-73 (Blarcamesine) in Patients with Parkinson’s Disease

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 Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today announced that the Shake It Up Foundation for Parkinson’s 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 ANAVEX®2-73 (blarcamesine) for the disease modifying treatment of Parkinson’s disease.

“Shake It Up is proud and excited to support research like this that may create opportunities for breakthroughs that could be a game-changer for people with Parkinson’s,” said Clyde Campbell, Founder and CEO of the Shake It Up Foundation. “The potential of a disease modifying treatment for Parkinson’s disease could be a very promising next step in further human testing of ANAVEX®2-73 (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 ANAVEX®2-73 (blarcamesine) and to evaluate ANAVEX®2-73 (blarcamesine) for Parkinson’s 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 Parkinson’s disease, and brings deep experience and an extensive network within the Parkinson’s community,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex.

The planned clinical study will use a convenient, once-daily oral ANAVEX®2-73 (blarcamesine) formulation to confirm the previously established potential disease modifying features of ANAVEX®2-73 (blarcamesine) in an animal model of Parkinson’s disease. Safety and efficacy will be investigated in an appropriately powered placebo-controlled clinical study of Parkinson’s disease patients over at least 48-weeks including ANAVEX®2-73-specific precision medicine biomarkers. All patients who participate in the study will be eligible to receive ANAVEX®2-73 (blarcamesine) under a voluntary open label extension protocol.

About Shake It Up Australia Foundation for Parkinson’s Research

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

About Parkinson’s Disease

Parkinson’s 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. Parkinson’s 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 Parkinson’s 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 ANAVEX®2-73 (blarcamesine)

ANAVEX®2-73 (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 Alzheimer’s disease (AD) study, ANAVEX®2-73 (blarcamesine) 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 (blarcamesine) Phase 2a AD patients was performed. The ANAVEX®2-73 (blarcamesine) Phase 2 Parkinson’s disease dementia (PDD) study design includes genomic biomarkers identified in the ANAVEX®2-73 (blarcamesine) Phase 2a AD study. Studies of ANAVEX®2-73 (blarcamesine) in a disease modifying model of Parkinson’s disease indicates that ANAVEX®2-73 (blarcamesine) is well tolerated, induces significant motor recovery (p