Anavex Life Sciences Corp (AVXL)

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Anavex Life Sciences Reports Publication of ANAVEX®3-71 in Clinical Journal Confirming Pharmacokinetic Dose Proportionality of ANAVEX® 3-71 in Humans



NEW YORK – January 24, 2024
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 upcoming U.S. Phase 2 clinical trial in Schizophrenia with ANAVEX®3-71.”

The paper can be accessed online at: https://pubmed.ncbi.nlm.nih.gov/38073274/.

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