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Mar2022

Anavex Life Sciences and Elara Pharmaceuticals Ltd present positive phase II clinical and biomarker data at the AD/PD 2022 International Conference

Anavex Life Sciences and Elara Pharmaceuticals Ltd present positive phase II clinical and biomarker data at the AD/PD 2022 International Conference

Pushing the promise of AI designed Precision Medicine Parkinson’s Disease Dementia (PDD) therapy closer to the finish line, Tersan, the AI Drug Development Company and ANAVEX Life Sciences announced positive ANAVEX®2-73 Phase II results.

Cambridge, Mass. and Paris, France, March 21st, 2022. Elara Pharmaceuticals Ltd, the eXplainable Artificial Intelligence clinical development Company, announced today the presentation of Phase 2 clinical biomarker data from the ANAVEX2-73-PDD-001 Parkinson’s Disease Dementia (PDD) study at the AD/PD 2022 International Conference.

MDS-UPDRS Total score improved significantly for patients treated with ANAVEX®2-73 high oral once-daily dose compared to placebo. The improvement is clinically relevant, corresponding to a relative improvement of 18.9% over 14 weeks. Balanced and global improvements were observed within all MDS-UPDRS sub-scores Part I-IV.

SIGMAR1 mRNA expression biomarker, previously identified using Tersan’s eXplainable Artificial Intelligence (xAI) KEM® technology, was significantly increased in ANAVEX®2-73 treated patients vs. placebo over the course of treatment (p=0.035). In addition, this biomarker was significantly associated with improvements of MDS-UPDRS scores and cognitive efficacy endpoints CDR system.

Anavex AD/PD 2022 International Conference

 Age,  certain neurophysiological measures, and high systolic blood pressure at baseline were identified with an increased response for the endpoints. 

This finding builds on the KEM® AI-driven precision medicine clinical development platform of ANAVEX®2-73, where the SIGMAR1 mRNA expression biomarker as previously identified as a potential biomarker (Hampel et al, Alzheimer Dement (N Y). 2020; 6(1): e12013) is characterized across multiple indications, including Alzheimer’s Disease and Rett syndrome.

“The reported strong positive biomarker and clinical results in Parkinson’s Disease Dementia, building on previously reported positive results in RETT syndrome and Alzheimer’s disease, further illustrate the power of KEM® Explainable AI to accelerate precision medicine drug development building on in-depth understanding of the intersection between SIGMAR1 molecular pathways and disease biology” said Mohammad Afshar, M.D., Ph.D., Chief Executive Officer of Elara Pharmaceuticals Ltd.

 

More information

Poster: ANAVEX®2-73 (blarcamesine): Analysis Of Movement (MDS-UPDRS) And Cognitive (CDR System) Pharmacodynamic Biomarker Outcome Measures of Placebo-Controlled Phase 2 Trial in 132 Parkinson’s Disease Dementia Patients J. Kulisevsky, T. Fadiran, E. Hammond, C. Missling, C. Williams, F. Parmentier, M. Kindermans & M. Afshar. Proceedings of the AD/PD™ 2022 International Conference on Alzheimer’s & Parkinson’s Diseases and related neurological disorders. Barcelona, Spain, March 15–20, 2022 – click here

ANAVEX’s press release – click here

About Elara Pharmaceuticals Ltd

Elara Pharmaceuticals Ltd is a leading Artificial Intelligence (AI) drug development company. Using its KEM® Artificial Intelligence (xAI) technology, Tersan helps its partners introduce personalized medicine clinical trial design into their protocols and optimize clinical endpoints, identify biomarkers of therapeutic response and potential synergistic therapies. 

Tersan routinely collects and combines clinical data with omic data, immunological readouts (such as Fluorescence-Activated Cell Sorting (FACS)), microbiota, Patient Reported Outcomes (PRO) as well as Real World Evidence (RWE) data. Combining advanced data analytics, drug development, and regulatory expertise, Tersan helps translate findings into innovative clinical development plans and regulatory approvals.

With a growing number of successful therapeutic development programs, KEM® is an FDA-assessed technology that systematically explores combinations of biomarkers, producing more effective biomarker signatures for precision medicine. Tersan has developed Onco KEM®, the most advanced, clinically tested, oncology therapeutic decision support system. Founded in 2003 as a spin-off of the Institut Pasteur, Paris, France, the company operates a subsidiary in the United Kingdom since 2012.

Further information is available at www.elarapharma.com.