Artificial Intelligence enables first biomarker driven precision medicine therapy against Alzheimer September, 2018
Ariana Pharma helps ANAVEX® demonstrate efficacy of its Alzheimer’s therapy in phase 2a clinical trial.
Ariana’s KEM® Artificial Intelligence technology has resulted in the identification of the first actionable genetic variant biomarkers, selecting a specified Alzheimer’s disease population, who demonstrated a confirmed response with ANAVEX®2-73.
These results provide support for a faster precision medicine clinical development of ANAVEX®2-73 focusing on the right patients who could benefit from the drug.
“This is the first full genomic analysis of ANAVEX®2-73 in Alzheimer’s disease which resulted in the identification of actionable genetic variants, bringing us one step closer to realizing the full potential of a precision medicine and precision pharmacology approach to treating this devastating disease,” Professor Harald Hampel, M.D., Ph.D., MA, MSc, AXA Research Fund & Sorbonne University Excellence Chair, Department of Neurology, Sorbonne University, Paris.
“The innovative study findings based on ANAVEX®2-73 moves precision medicine and pharmacology a step closer in Alzheimer’s therapy trials,” Christopher U. Missling, Ph.D., President and Chief Executive Officer of Anavex.
“… in CNS-based studies, whether AD or MS, the data are complex across multiple endpoints. As such, having KEM® system with Ariana in place to help analyze complex data is, in our view, a strategic positive for Anavex.” Jason Kolbert, former Executive Managing Director and Head of Healthcare Research at Maxim Group, Managing Director of Research at HC Wainwright & Co. Identifying the right patient population, the use of Ariana’s proprietary KEM® AI technology has a proven track of increasing the chances of success, accelerating clinical timelines and creating immediate value for the Company.
KEM® is a comprehensive and FDA-tested clinical data analysis system that enables full exploitation of complex datasets. It has uniquely demonstrated its ability to extract biomarkers from small sets of patients.
Beyond CNS, Ariana’s expertise spans multiple medical indications and therapeutic areas, including cancer, metabolic and immunological diseases.
Further reading
Anavex presents results at CTAD, Barcelona (October 2018)
PRESENTATION – Longitudinal 148-Week Extension Study for ANAVEX®2-73 Phase 2a Alzheimer’s Disease Demonstrates Maintained Activities of Daily Living Score (ADCS-ADL) and Reduced Cognitive Decline (MMSE) for Patient Cohort on Higher Drug Concentration and Confirms Role of Patient Selection Biomarkers [Link: Document] Biomarker data presented at AAIC, Chicago (July 2018)
Anavex Life Sciences Presents New Data Identifying Treatment Response Biomarkers in Alzheimer’s Disease Patients Treated with Investigational ANAVEX®2-73 at 2018 Alzheimer’s Association International Conference (AAIC) Read more
ABSTRACT – Full Genomic Analysis of ANAVEX®2-73 Phase 2a Alzheimer’s Disease Study Identifies Biomarkers Enabling Targeted Therapy and a Precision Medicine Approach [Link: Document]
ABSTRACT – Systematic Processing of Full Genomic Analysis of ANAVEX®2-73 Phase 2a Alzheimer’s Disease Study Identifies Biomarkers Enabling a Precision Medicine Approach [Link: Document]
POSTER – Full Genomic Analysis of ANAVEX®2-73 Phase 2a Alzheimer’s Disease Study Identifies Biomarkers Enabling Targeted Therapy and a Precision Medicine Approach [Link: Document]
PRESENTATION – Systematic Processing of Full Genomic Analysis of ANAVEX®2-73 Phase 2a Alzheimer’s Disease Study Identifies Biomarkers Enabling a Precision Medicine Approach [Link: Document]
NASDAQ – Anavex Life Sciences Presents New Data Identifying Treatment Response Biomarkers in Alzheimer’s Disease Patients Treated with Investigational ANAVEX®2-73 at 2018 Alzheimer’s Association International Conference (AAIC) Read more Mohammad Afshar presents results at CTAD, Boston (November 2017)
Anavex Life Sciences Reports PK and PD Data from Phase 2a Trial of ANAVEX®2-73 in Mild-to-Moderate Alzheimer’s Disease Patients Read more
ABSTRACT – Clinical pharmacokinetics and pharmacodynamics characterization of ANAVEX™2-73 for designing a phase 2/3 study in mild-to-moderate Alzheimer’s disease [Link: Document]
PRESENTATION – Clinical Pharmacokine/cs and Pharmacodynamics Characteriza/on of ANAVEX®2-73 for Designing a Phase 2/3 Study in Mild-to-Moderate Alzheimer’s Disease – CTAD November 2017 [Link: Document] Initiating collaboration (October 2016)
Anavex Life Sciences and Ariana Pharma Collaborate to Accelerate Timelines and Improve Efficiency of Alzheimer’s and Parkinson’s Clinical Development Programs Read more
NASDAQ – Anavex Life Sciences (AVXL) was up 9,3% after teaming up with Ariana Pharma [Link: Document]
Focusing on the right patients is exactly what defines precision or personalised medicine.
“These results provide support for a faster precision medicine clinical development of ANAVEX®2-73 focusing on the right patients who could benefit from the drug.”
Anavex have yet to enroll and focus on the right patients in any trial, based on what have been learned about those patient profiles. I expect we are going to see the first such Precision Medicine trial when the Parkinson’s movement trial is initiated.
Post selective subgroup analysis is not identical to preselecting the right patients. We will have to see if the P2b/3 AD trial has large enough subgroups of responders that given the unmet need and safety might lead to early approval.
That effort doesn’t seem to gel with the claim that all endpoints were met.
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