GlobeNewswire Inc | Jan 10, 2022 07:00AM EST

January 10, 2022

Study reached primary and secondary endpoints of safety, respectively

ANAVEX3-71 well tolerated as oral administration in all dose cohorts

No serious adverse events or dose-limiting toxicities observed

Data provide early clinical proof of ANAVEX3-71 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 Alzheimers disease, Parkinsons disease, Rett syndrome and other central nervous system (CNS) disorders, today announced positive top-line results from its Phase 1 clinical trial of ANAVEX3-71, 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 ANAVEX3-71 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 ANAVEX3-71 including effects of food and gender in healthy volunteers.

ANAVEX3-71 was well tolerated in all cohorts receiving ANAVEX3-71 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, ANAVEX3-71 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 ANAVEX3-71. The study also met the secondary objective of characterizing the effect of ANAVEX3-71 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 ANAVEX3-71 and Placebo.

We are pleased with the Phase 1 trial results for ANAVEX3-71 and are eager to advance ANAVEX3-71 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 Anavexs 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 ANAVEX3-71 pre-clinical profile, the Company intends to advance ANAVEX3-71 into a biomarker-driven clinical development dementia program for the treatment of FTD, schizophrenias and Alzheimers disease, evaluating longitudinal effect of treatment with ANAVEX3-71 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 ANAVEX3-71 in healthy volunteers. The live webcast can be accessed on the investor page of Anavexs 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 ANAVEX3-71

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 ANAVEX3-71 were administered in order to evaluate the safety, tolerability, and pharmacokinetics (PK) of ANAVEX3-71 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 Alzheimers 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 ANAVEX3-71

ANAVEX3-71, previously AF710B, represents Anavexs 2nd novel clinical sigma-1 and muscarinic receptor program parallel to ANAVEX2-73 (blarcamesine). Anavex is developing ANAVEX3-71 initially for the treatment of Frontotemporal Dementia (FTD), for which ANAVEX3-71 was previously granted orphan drug designation by the FDA. ANAVEX3-71 demonstrated disease-modifying activity against the major hallmarks of Alzheimers 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 Alzheimers disease, Parkinsons disease, Rett syndrome and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavexs lead drug candidate, ANAVEX2-73 (blarcamesine), successfully completed a Phase 2a clinical trial for Alzheimers disease and recently a Phase 2 proof-of-concept study in Parkinsons disease dementia and a Phase 2 study in adult patients with Rett syndrome. ANAVEX2-73 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 Alzheimers disease. ANAVEX2-73 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 Parkinsons Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX2-73 for the treatment of Parkinsons disease. ANAVEX3-71, which targets sigma-1 and muscarinic M1 receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimers disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX3-71 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 Companys 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 DevelopmentToll-free: 1-844-689-3939Email: info@anavex.com

Investors:Andrew J. BarwickiInvestor RelationsTel: 516-662-9461Email: andrew@barwicki.com

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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 M1/1 Agonist with Therapeutic Efficacy in Animal Models of Alzheimers Disease.Neuro-degenerative diseases,16(1-2), 95110. https://doi.org/10.1159/000440864