NEW YORK, NY – October 5, 2016 – 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 diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, today announced a collaboration with Elara Pharmaceuticals Ltd (Cambridge, MA and Paris, France) to use Tersan’s proprietary KEM® (Knowledge, Extraction, Management) patient stratification technology to potentially accelerate ANAVEX 2-73’s Phase 2/3 Alzheimer’s clinical development timelines. KEM® is a comprehensive and FDA-tested clinical data analysis system that enables full exploitation of complex datasets including of smaller numbers of patients.
“We are very impressed with the rational and efficient clinical trial path Anavex has embarked upon by adopting population pharmacokinetics (PK) and adaptive trial design in its current ANAVEX 2-73 Phase 2a study in Alzheimer’s disease,” said Mohammad Afshar, CEO of Elara Pharmaceuticals Ltd. “Tersan has the expertise to fully support Anavex’s precision medicine approach to develop more effective treatments for devastating diseases including Alzheimer’s, Parkinson’s and Rett syndrome.”
Tersan specializes in clinical patient stratification using KEM®, a proprietary decision support technology for rapid and systematic analysis of multi-parametric/multi-objective data. Tersan’s technology uncovers signals and complex relationships overlooked by conventional statistical analysis that minimizes the risk of data over-fitting. This approach increases clinical trial success and reduces drug development risks by systematically identifying patient subgroups most benefiting from a drug and endpoints that best capture its effect. Tersan is one of the first companies to implement the new FDA draft enrichment guidelines for patient stratification and trial enrichment. Tersan’s expertise spans multiple medical indications and therapeutic areas, including immunological and neurological diseases and cancer.
Anavex’s 32-patient Alzheimer’s study utilizing KEM® will enable systematic analysis of more data on each patient in the disease group, on par with similar studies of significantly larger size, while providing greater cost and time efficiency.
“The ongoing Phase 2a Alzheimer’s clinical trial was specifically designed to learn as much as possible about ANAVEX 2-73 in order to optimize trial parameters for future pivotal trials and potentially reduce the risk of failure in a later, larger Phase 2/3 study and in a planned Parkinson’s Phase 2 study. We believe that the collaboration with Elara Pharmaceuticals Ltd will potentially accelerate the development process,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex.