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

Rhea-AI Summary

Anavex Life Sciences Corp. (Nasdaq: AVXL) announced an investment commitment from the Shake It Up Foundation for Parkinson’s Research, covering up to 50% of the costs for a clinical study on ANAVEX®2-73 (blarcamesine) aimed at treating Parkinson’s disease. The study will evaluate safety and efficacy through a placebo-controlled trial over at least 48 weeks, using a once-daily oral formulation. Previous studies highlighted ANAVEX®2-73's potential to modify disease progression, showing promising results in animal models.

Positive

• Shake It Up Foundation invests up to 50% in clinical study for ANAVEX®2-73.
• Clinical study aims to evaluate safety and efficacy over at least 48 weeks.
• Previous animal studies indicated ANAVEX®2-73 may modify disease progression.

Negative

• None.

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<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 disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, pain and various types of cancer. Anavex’s lead drug candidate, ANAVEX®2-73 (blarcamesine), recently completed a successful Phase 2a clinical trial for Alzheimer’s disease. ANAVEX®2-73 (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 Alzheimer’s disease. ANAVEX®2-73 (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 Parkinson’s Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 (blarcamesine) for the treatment of Parkinson’s disease. ANAVEX®3-71, which targets sigma-1 and 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 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 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.

For Further Information:

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

Investors & Media:

Email: ir@anavex.com 

FAQ

What is the purpose of the ANAVEX®2-73 clinical study?

The clinical study aims to evaluate the safety and efficacy of ANAVEX®2-73 for the disease-modifying treatment of Parkinson’s disease.

How much is the Shake It Up Foundation investing in Anavex?

The Shake It Up Foundation has committed to invest up to 50% of the costs for the clinical study of ANAVEX®2-73.

What are the expected outcomes of the ANAVEX®2-73 study for Parkinson’s disease?

The study will assess safety, tolerability, and efficacy in patients, potentially establishing ANAVEX®2-73 as a disease-modifying treatment.

How long will the ANAVEX®2-73 clinical study last?

The clinical study is planned to last for at least 48 weeks.

What previous results support the use of ANAVEX®2-73 in Parkinson’s disease?

Previous studies in animal models showed that ANAVEX®2-73 can induce significant motor recovery and neurohistological restoration.