Anavex Life Sciences Reports Positive Results from Phase 1 Clinical Trial of ANAVEX®3-71

Rhea-AI Summary

Anavex Life Sciences Corp. (Nasdaq: AVXL) announced positive top-line results from its Phase 1 clinical trial of ANAVEX^®3-71, a treatment for neurodegenerative diseases. The trial met primary and secondary safety endpoints, showing that the drug was well tolerated across all dose cohorts (5 mg to 200 mg) with no serious adverse events or dose-limiting toxicities. The drug exhibited linear pharmacokinetics and no significant food effects. Anavex plans to advance ANAVEX^®3-71 into Phase 2 trials, aiming for a biomarker-driven program in treating Frontotemporal Dementia and Alzheimer's disease.

Positive

• Phase 1 clinical trial met primary and secondary endpoints.
• ANAVEX^®3-71 was well tolerated in all doses.
• No serious adverse events or dose-limiting toxicities reported.
• Demonstrated linear pharmacokinetics and no food effect on bioavailability.
• Plans to advance into Phase 2 clinical trials for FTD and Alzheimer's.

Negative

• None.

Study reached primary and secondary endpoints of safety, respectively

ANAVEX^®3-71 well tolerated as oral administration in all dose cohorts

No serious adverse events or dose-limiting toxicities observed

Data provide early clinical proof of ANAVEX^®3-71 having same pharmacokinetics in both gender and no food effect

Company to host a webcast today at 8:30 a.m. ET

NEW YORK, Jan. 10, 2022 (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) disorders, today announced positive top-line results from its Phase 1 clinical trial of ANAVEX^®3-71, an oral small molecule agonist of both SIGMAR1 and CHRM1 (Cholinergic Receptor Muscarinic M1) in development for the treatment of neurodegenerative diseases including Frontotemporal Dementia (FTD), for which ANAVEX^®3-71 has been granted Orphan Drug Designation (ODD) by the FDA.

The study was a double-blind, randomized, placebo-controlled, Phase 1 trial to evaluate safety and tolerability, and pharmacokinetics (PK) of oral escalating doses of ANAVEX^®3-71 including effects of food and gender in healthy volunteers.

ANAVEX^®3-71 was well tolerated in all cohorts receiving ANAVEX^®3-71 in single doses ranging from 5 mg to 200 mg daily with no serious adverse events (SAEs) and no significant lab abnormalities in any subject. In the study, ANAVEX^®3-71 exhibited linear pharmacokinetics. Its pharmacokinetics was also dose proportional for doses up to 160 mg. Gender had no effect on the PK of the drug and food had no effect on the bioavailability of ANAVEX^®3-71. The study also met the secondary objective of characterizing the effect of ANAVEX^®3-71 on electrocardiogram (ECG) parameters. There were no clinically significant ECG parameters throughout the study. Participant QTcF measures were normal across all dose groups with no difference between ANAVEX^®3-71 and Placebo.

“We are pleased with the Phase 1 trial results for ANAVEX^®3-71 and are eager to advance ANAVEX^®3-71 into Phase 2,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “These encouraging results provide a proof of concept of our SIGMAR1 product platform and helps validate Anavex’s approach to CNS target selection and drug discovery and increases Anavex’ confidence in the potential of our precision medicine technology to address serious neurodegenerative diseases.”

Based on these results, and ANAVEX^®3-71 pre-clinical profile, the Company intends to advance ANAVEX^®3-71 into a biomarker-driven clinical development dementia program for the treatment of FTD, schizophrenias and Alzheimer’s disease, evaluating longitudinal effect of treatment with ANAVEX^®3-71 initiating in 2022. Anavex believes the results of this study, could serve as the basis for advancing into respective registration studies in the U.S.

Conference Call Information

Anavex Life Sciences will host a webcast today at 8:30 a.m. ET to discuss the top-line results from the Phase 1 clinical trial of ANAVEX^®3-71 in healthy volunteers. The live webcast can be accessed on the investor page of Anavex’s website at www.anavex.com. A replay of the webcast will be available and will be archived for up to 30 days.

About the Phase 1 trial with ANAVEX^®3-71

The phase 1 clinical trial was a prospective double-blind, randomized, placebo-controlled study. A total of 42 healthy male and female subjects were included. Single escalating doses of ANAVEX^®3-71 were 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 patients with FTD, schizophrenias and Alzheimer’s disease incorporating efficacy and disease biomarker measures. More information about the Phase 1 trial is available on clinicaltrials.gov, under ClinicalTrials.gov Identifier: NCT04442945.

About ANAVEX^®3-71

ANAVEX^®3-71, previously AF710B, 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 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), successfully completed a Phase 2a clinical trial for Alzheimer’s disease and recently a Phase 2 proof-of-concept study in Parkinson’s disease dementia and a Phase 2 study in adult patients with Rett syndrome. ANAVEX^®2-73 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 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 for the treatment of Parkinson’s disease. ANAVEX^®3-71, which targets sigma-1 and muscarinic M1 receptors, is a promising clinical stage 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, Instagram 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:
Andrew J. Barwicki
Investor Relations
Tel: 516-662-9461
Email: andrew@barwicki.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 were the results of the ANAVEX®3-71 Phase 1 clinical trial?

The Phase 1 trial met all primary and secondary safety endpoints, showing that ANAVEX®3-71 was well tolerated with no serious adverse events.

What is ANAVEX®3-71 designed to treat?

ANAVEX®3-71 is being developed for neurodegenerative diseases, specifically Frontotemporal Dementia and Alzheimer's disease.

What are the next steps for ANAVEX®3-71 following the Phase 1 trial?

Anavex plans to progress ANAVEX®3-71 to Phase 2 clinical trials, focusing on a biomarker-driven development program.

What is the significance of the safety results in the ANAVEX®3-71 trial?

The safety results confirm that ANAVEX®3-71 can be safely administered to healthy volunteers, paving the way for its use in patient populations.

When will the Phase 2 trials for ANAVEX®3-71 begin?

The Phase 2 trials for ANAVEX®3-71 are set to initiate in 2022.