Anavex presents new data of Alzheimer's treatment ANAVEX2-73
Anavex presented new clinical pharmacokinetic and pharmacodynamic data for ANAVEX2-73 in a late-breaking oral presentation at the 2017 Clinical Trials on Alzheimer's Disease Meeting. Data presented include new results from the Phase 1 study, the Phase 2a study, and data from the first year of the Phase 2a long-term extension study. At 109 weeks and halfway into the long-term extension Phase 2a study ANAVEX2-73-003, data from the cohort of patients with the highest ANAVEX2-73 concentrations point toward the continued ability of the medication to stop the decline in the exploratory secondary endpoints cognition and function. At 57 weeks, this cohort had demonstrated improvement of the measures MMSE and ADCS-ADL compared to baseline. For the primary endpoint, ANAVEX2-73 demonstrated continued favorable safety and tolerability through 109 weeks. Additionally, clinical data from 54 subjects from the Phase 1 and the Phase 2a trials were analyzed including using formal concept analysis, non-linear mixed effect modeling and non-compartmental analysis methods. This data provide support to proceed with the clinical development of ANAVEX2-73 for Alzheimer's disease in a focused Phase 2/3 study using the precision medicine paradigm, including DNA whole exome, RNA expression and gut microbiome characterization. Further clinical studies in other indications, such as Rett syndrome and Parkinson's disease are under development utilizing the translational potential of precision medicine approach of ANAVEX2-73. ANAVEX2-73 is a novel, orally available sigma-1 receptor agonist. Sigma-1 receptor, an emerging therapeutic target in Alzheimer's disease and other central nervous system disorders, has been shown to reduce cellular stress and regulate neuroplasticity and cellular homeostasis. The Company previously reported that the Phase 2a trial successfully achieved both primary and secondary endpoints.