Press release
Anavex Life Sciences Reports Publication of ANAVEX®3-71 in Clinical Journal Confirming Pharmacokinetic Dose Proportionality of ANAVEX®3-71 in Humans
NEW YORK, Jan. 24, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company
About this update from Anavex Life Sciences Corp.
[{"type":"text","content":"NEW YORK, Jan. 24, 2024 (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 a peer-reviewed publication in Clinical Pharmacology in Drug Development, findings from the ANAVEX®3-71 first-in-human study which achieved its safety objectives. The publication is entitled, ‘Population-Based Characterization of the Pharmacokinetics and Food Effect of ANAVEX3-71, a Novel Sigma-1 Receptor and Allosteric M1 Muscarinic Receptor Agonist in Development for Treatment of Frontotemporal Dementia, Schizophrenia, and Alzheimer Disease’.1 The publication reports the Population-based characterization of the Pharmacokinetics (PK) and food effect of ANAVEX®3-71 as part of the single ascending dose study in healthy participants with the primary objective of assessing dose proportionality of ANAVEX®3-71, and to characterize the effect of food on the PK of ANAVEX®3-71. The results from this PK evaluation demonstrated that ANAVEX®3-71, at single ascending doses of 5 to 200 mg, is linear, dose proportional, and time invariant. Food had no effect on the PK of ANAVEX®3-71. This data also expands the safety objectives met in this first-in-human study of ANAVEX®3-71, further supporting its drug development program. While KarXT from Karuna Therapeutics (KRTX), a muscarinic M1 receptor agonist, demonstrated weak benefits on cognitive impairments in individuals with Schizophrenia,2 ANAVEX®3-71’s dual-pharmacological action on SIGMAR1 and M1 muscarinic receptors is implicated in its pro-cognitive effects in murine Alzheimer’s disease models and demonstrates its potential to treat cognitive and behavioral deficits in neurological diseases by affecting protein homeostasis in the central nervous system.3,4,5 “This published clinical study demonstrates Anavex’s commitment to advance Anavex’s clinical pipeline including ANAVEX®3-71 for Schizophrenia, Frontotemporal Dementia, and Alzheimer's Disease,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. \"We are looking forward to reporting first patient dosed in the upc...