Anavex Life Sciences Receives Regulatory Approval from Health Canada and UK MHRA Expanding Phase 2b/3 ANAVEX®2-73 (blarcamesine) into Multinational Clinical Trial for Alzheimer’s Disease

Rhea-AI Summary

Anavex Life Sciences Corp. (Nasdaq: AVXL) has received a No Objection Letter from Health Canada and Clinical Trial Authorization from the MHRA in the UK to expand its Phase 2b/3 trial of ANAVEX^®2-73 (blarcamesine) for early Alzheimer's disease into Canada and the UK. The ongoing study, currently over 50% enrolled, aims to assess safety and efficacy in 450 patients. CEO Christopher U. Missling expressed optimism that these approvals will expedite enrollment and advance the company's mission to treat neurodegenerative disorders.

Positive

• Received regulatory approvals from Health Canada and MHRA for trial expansion into Canada and UK.
• Ongoing Phase 2b/3 trial currently over 50% enrolled, indicating strong interest.
• Trial aims to improve treatment options for early Alzheimer's disease.

Negative

• None.

NEW YORK, June 04, 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 disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today announced that it has received a No Objection Letter from Health Canada as well as Clinical Trial Authorization (CTA) from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) to expand the Phase 2b/3 double-blind, randomized, placebo-controlled safety and efficacy trial (Study ANAVEX^®2-73-AD-004) of ANAVEX^®2-73 (blarcamesine) for the treatment of early Alzheimer’s disease into Canada and UK, respectively.

The 48-week Phase 2b/3 study ANAVEX^®2-73-AD-004 (ClinicalTrials.gov NCT03790709) of ANAVEX^®2-73 (blarcamesine) using biomarker and precision medicine in 450 patients with early Alzheimer’s disease is ongoing and currently over 50% enrolled.

“We are excited to receive the regulatory approvals for this Phase 2b/3 study for patients seeking treatment for Alzheimer’s disease,” commented Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “This expansion into North America and Europe should accelerate the completion of the enrollment of the ongoing ANAVEX^®2-73-AD-004 Alzheimer’s disease Phase 2b/3 trial with ANAVEX^®2-73 (blarcamesine).”

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. S1R activation has demonstrated ability to reduce key pathophysiological signs of Alzheimer’s disease: beta amyloid, hyperphosphorylated tau, and increased inflammation. In the Phase 2a 57-week Alzheimer’s disease (AD) ANAVEX^®2-73-002 (ClinicalTrials.gov NCT02244541) study, ANAVEX^®2-73 (blarcamesine) has shown dose dependent improvement in exploratory endpoints of cognition (MMSE) and function (ADCS-ADL). Its open-label extension study ANAVEX^®2-73-003 (ClinicalTrials.gov NCT02756858) for an additional 208 weeks included full genomic analysis of patients with Alzheimer’s disease treated with ANAVEX^®2-73 (blarcamesine). A 48-week Phase 2b/3 study ANAVEX^®2-73-AD-004 (ClinicalTrials.gov NCT03790709) of ANAVEX^®2-73 (blarcamesine) in 450 patients with early Alzheimer’s disease is ongoing and currently over 50% enrolled.

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 (blarcamesine) trial?

The trial aims to assess the safety and efficacy of ANAVEX®2-73 in patients with early Alzheimer's disease.

When did Anavex receive regulatory approvals for its trial?

Anavex received the No Objection Letter from Health Canada and Clinical Trial Authorization from the MHRA in the UK on June 4, 2020.

How many patients are enrolled in the ANAVEX®2-73 phase 2b/3 trial?

The trial aims to enroll 450 patients and is currently over 50% enrolled.

What is the expected impact of the trial for Anavex Life Sciences?

The trial is expected to accelerate the development of treatment options for Alzheimer's, potentially enhancing Anavex's market position.