Anavex Life Sciences Announces First Participant Enrolled in Phase 1 Study of ANAVEX®3-71 (AF710B)

Rhea-AI Summary

Anavex Life Sciences Corp. (Nasdaq: AVXL) announced the enrollment of the first participant in a Phase 1 trial for ANAVEX®3-71, a small molecule targeting sigma-1 and M1 muscarinic receptors. This trial aims to evaluate the safety and pharmacokinetics of the drug, initially focused on Frontotemporal Dementia (FTD). The company anticipates topline data in the first half of 2021. ANAVEX®3-71 has shown promising preclinical results, demonstrating disease-modifying activity against Alzheimer’s disease hallmarks.

Positive

• Enrollment of the first participant in Phase 1 trial for ANAVEX®3-71.
• Promising preclinical data showing disease-modifying activity in Alzheimer's models.
• Orphan drug designation granted by FDA for ANAVEX®3-71.

Negative

• None.

NEW YORK, July 06, 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 the enrollment of the first participant in a Phase 1 clinical trial of ANAVEX®3-71 (AF710B), an orally-administered small molecule targeting sigma-1 and M1 muscarinic receptors that is designed to be beneficial for neurodegenerative diseases with topline data anticipated in the first half of 2021.

“Based upon our encouraging preclinical data with ANAVEX®3-71, we are intrigued learning about the initial experience with the healthy volunteers who are enrolling in this trial as an innovative approach to potentially treat neurodegenerative diseases,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex.

This represents Anavex’s 2^nd novel clinical sigma-1 and muscarinic receptor program parallel to ANAVEX®2-73 (blarcamesine). Anavex is developing ANAVEX®3-71 initially for the treatment of Frontotemporal Dementia (FTD), for which ANAVEX®3-71 was previously granted orphan drug designation by the FDA. ANAVEX®3-71 demonstrated disease-modifying activity against the major hallmarks of Alzheimer’s disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, as well as beneficial effects on mitochondrial dysfunction and neuroinflammation.¹

About the Phase 1 trial with ANAVEX®3-71

The phase 1 clinical trial will be a prospective double-blind, randomized, placebo-controlled study. A total of at least 36 healthy male and female subjects will be included. Single escalating doses of ANAVEX®3-71 will be administered in order to evaluate the safety, tolerability, and pharmacokinetics (PK) of ANAVEX®3-71 and the effects of food and gender on its PK in healthy volunteers. This study will be followed by longer duration dosing including FTD patients and incorporating exploratory efficacy and disease biomarker measures. More information about the trial is available on clinicaltrials.gov, under ClinicalTrials.gov Identifier: NCT04442945.

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

¹ Fisher, A., Bezprozvanny, I., Wu, L., Ryskamp, D. A., Bar-Ner, N., Natan, N., Brandeis, R., Elkon, H., Nahum, V., Gershonov, E., LaFerla, F. M., & Medeiros, R. (2016). AF710B, a Novel M1/σ1 Agonist with Therapeutic Efficacy in Animal Models of Alzheimer’s Disease. Neuro-degenerative diseases, 16(1-2), 95–110. https://doi.org/10.1159/000440864

FAQ

What is the purpose of the Phase 1 trial for ANAVEX®3-71?

The Phase 1 trial is designed to evaluate the safety, tolerability, and pharmacokinetics of ANAVEX®3-71 in healthy volunteers.

When can we expect topline data from the ANAVEX®3-71 trial?

Topline data from the Phase 1 trial for ANAVEX®3-71 is anticipated in the first half of 2021.

What diseases is ANAVEX®3-71 targeting?

ANAVEX®3-71 is being developed for Frontotemporal Dementia and other neurodegenerative diseases.

What were the preclinical results for ANAVEX®3-71?

Preclinical studies indicated that ANAVEX®3-71 demonstrated disease-modifying activity against key Alzheimer's disease hallmarks.

What is the significance of the orphan drug designation for ANAVEX®3-71?

The orphan drug designation by the FDA provides certain benefits, including market exclusivity and potential financial incentives for developing treatments for rare diseases.