Press release
Anavex Life Sciences Reports Positive Results from Phase 1 Clinical Trial of ANAVEX®3-71
Study reached primary and secondary endpoints of safety, respectively ANAVEX®3-71 well tolerated as oral administration in all dose cohorts No serious adverse
About this update from Anavex Life Sciences Corp.
[{"type":"text","content":"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...