Anavex Life Sciences Announces First Participant Enrolled in Phase 1 Study of ANAVEX3-71 (AF710B)

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 ANAVEX3-71 (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 ANAVEX3-71, 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 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 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 ANAVEX3-71

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 ANAVEX3-71 will be 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 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.