Anavex reports publication of ANAVEX 3-71 human study in clinical journal

Anavex Life Sciences announced a peer-reviewed publication in Clinical Pharmacology in Drug Development, findings from the ANAVEX3-71 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 and food effect of ANAVEX3-71 as part of the single ascending dose study in healthy participants with the primary objective of assessing dose proportionality of ANAVEX3-71, and to characterize the effect of food on the PK of ANAVEX3-71. The results from this PK evaluation demonstrated that ANAVEX3-71, at single ascending doses of 5 to 200 mg, is linear, dose proportional, and time invariant. Food had no effect on the PK of ANAVEX3-71. This data also expands the safety objectives met in this first-in-human study of ANAVEX3-71, further supporting its drug development program. While KarXT from Karuna Therapeutics, a muscarinic M1 receptor agonist, demonstrated weak benefits on cognitive impairments in individuals with Schizophrenia, ANAVEX3-71’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. “This published clinical study demonstrates Anavex’s commitment to advance Anavex’s clinical pipeline including ANAVEX3-71 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 upcoming U.S. Phase 2 clinical trial in Schizophrenia with ANAVEX3-71.”