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Anavex Life Sciences Presents ANAVEX®2-73 (blarcamesine) Data at 12th Clinical Trials on Alzheimer's Disease (CTAD) 2019 Conference
Baseline-matched Real-World external Control Data with Alzheimer’s Disease Neuroimaging Initiative (ADNI): ANAVEX®2-73 (blarcamesine) Cohort showed a
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[{"type":"text","content":"Baseline-matched Real-World external Control Data with Alzheimer’s Disease Neuroimaging Initiative (ADNI): ANAVEX®2-73 (blarcamesine) Cohort showed a Significantly lower Cognitive Decline Compared to the ADNI Control Cohort at Interim 2-Year (104-Week) TimepointAbundance of Lachnospiraceae and Enterobacteriaceae Families as Potential Biomarker of Response from a 2-Year Study Interim Clinical Data Analysis of ANAVEX®2-73 (blarcamesine) NEW YORK, Dec. 04, 2019 (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) diseases, today announced Late Breaking Oral Communication at CTAD 2019.\n Interim 2-Year (104)-Week) data from the Phase 2a ANAVEX®2-73 (blarcamesine) extension study, with Alzheimer’s disease patients followed for up to five years, will be presented at the 12th Clinical Trials On Alzheimer's Disease (CTAD) 2019 Conference in San Diego, CA (December 4-7, 2019). “These results confirm the rationale to advance the ANAVEX®2-73 (blarcamesine) Alzheimer’s disease program through the ongoing Phase 2b/3 Alzheimer’s disease clinical study1,” said Christopher U. Missling, Ph.D., Chief Executive Officer of Anavex. “The data also establishes the findings of two further gut microbiota family biomarkers linked to improved response with ANAVEX®2-73 (blarcamesine).” FDA’s Framework for Real World Evidence document released in December 2018 demonstrates how Real World Evidence can be incorporated into regulatory decision-making. This framework was applied to the study of ANAVEX®2-73 (blarcamesine), a selective sigma-1 receptor (SIGMAR1) agonist that was investigated in an open-label 57-week Phase 2a study of Alzheimer’s Disease (AD) patients (N=32) showing a favourable safety profile (NCT02244541) and was further extended by 208 weeks (NCT02756858). A hypothesis free data-driven analysis using Formal Concept Analysis Machine Learning as implemented in Knowledge Extraction and Management (KEM) software platform was used to identify exploratory efficacy and patient selection biomarkers including SIGMAR1 p.Q2P (rs1800866). The goal of this study was...