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

NEW YORK, May 21, 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 approval by the Australian Human Research Ethics Committee to initiate the First-in-Human (FIH) clinical study 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.

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

“We are excited to expand the Anavex clinical portfolio by entering the clinic with ANAVEX3-71. Considerable efforts over the last few years to progress this program through IND-enabling GLP animal toxicology, manufacturing and drug formulation development have resulted in an orally available drug candidate with potential disease-modifying properties for vulnerable aged patients with serious morbidity and mortality associated with neurodegeneration,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “We are looking forward to generating the first clinical data on ANAVEX3-71.”

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.