Alzheimer’s – Elara Pharmaceuticals Ltd https://www.elarapharma.com The AI DRUG Development Company Wed, 29 Mar 2023 13:26:08 +0000 en-US hourly 1 https://wordpress.org/?v=5.8.2 https://www.elarapharma.com/wp-content/uploads/2021/12/cropped-android-chrome-512x512-1-1-32x32.png Alzheimer’s – Elara Pharmaceuticals Ltd https://www.elarapharma.com 32 32 CY6463 administration is linked to improvements in Alzheimer’s disease-relevant biomarkers, as revealed by eXplainable AI-driven analysis of multiple Phase 1 clinical trials ​ https://www.elarapharma.com/cy6463-administration-is-linked-to-improvements-in-alzheimers-disease-relevant-biomarkers-as-revealed-by-explainable-ai-driven-analysis-of-multiple-phase-1-clinical-trials-%e2%80%8b/?utm_source=rss&utm_medium=rss&utm_campaign=cy6463-administration-is-linked-to-improvements-in-alzheimers-disease-relevant-biomarkers-as-revealed-by-explainable-ai-driven-analysis-of-multiple-phase-1-clinical-trials-%25e2%2580%258b Wed, 30 Nov 2022 09:20:17 +0000 https://www.elarapharma.com/?p=8155 • Phase 1 studies show improvement in cognitive factors, consistent with therapeutic potential of CY6463 to improve key features in neurological diseases
• CY6463 favorable tolerability and safety profile was confirmed

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• Phase 1 studies show improvement in cognitive factors, consistent with therapeutic potential of CY6463 to improve key features in neurological diseases
• CY6463 favorable tolerability and safety profile was confirmed

Cambridge, MA, USA and Paris, France, November 30th, 2022 – Elara Pharmaceuticals Ltd, a leading Artificial Intelligence (AI) drug development company, in collaboration with Cyclerion Therapeutics, presented today safety and pharmacodynamic results from a post hoc analysis of CY6463 first-in-human studies at the 2022 Clinical Trials On Alzheimer’s Disease (CTAD) international conference held in San Francisco, USA.

Cyclerion Therapeutics’ CY6463 is a first-in-class, CNS-penetrant, soluble guanylate cyclase (sGC) stimulator that modulates a key node in a fundamental signaling pathway. CY6463 has been evaluated in two Phase 1 studies in healthy volunteers as well as signal-seeking patient studies in the rare mitochondrial disease, MELAS (mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes) and in CIAS (cognitive impairment associated with schizophrenia); a study in AD (Alzheimer’s disease) is ongoing. Cyclerion is advancing CY6463  for the treatment of rare mitochondrial diseases.

A total of 134 healthy participants were enrolled across two randomized, placebo-controlled, Phase 1 studies in which single-ascending doses, multiple-ascending doses, food effect (crossover design) and the pharmacology of CY6463 (crossover design) were evaluated. In each study, safety, pharmacokinetic, and endpoints assessments were collected at baseline and at the end of dosing. Previously reported favorable safety profile of CY6463 was confirmed, with no major adverse events.
Age, certain neurophysiological measures, and high systolic blood pressure at baseline were identified with an increased response for the endpoints.

A systematic analysis of both trials using Tersan’s KEM® (Knowledge Extraction & Management) eXplainable AI platform revealed the impact of higher dose of CY6463 on 5 endpoints related to spatial learning (Milner Maze Test speed and accuracy,  p=0.004 and p=0.045), brain activity (electroencephalography: increased alpha power, eyes closed, p = 0.003), inflammation (Matrix Metalloproteinase 3, p = 0.008) and target engagement (cyclic guanosine monophosphate, p=0.019), thus demonstrating the potential of CY6463 for the treatment of multiple neurological diseases.

Tersan’s KEM® also generated new hypotheses of patient-selection biomarkers that were linked with improved response; notably, age greater than 49 years old was linked with greater improvement in Milner Maze Test (speed p=0.095, accuracy p=0.047) and increase in effect size (Cohen’s d) by 41% and 118% respectively, while baseline systolic blood pressure greater than or equal to 121 mmHg was linked with greater improvement in Milner Maze Test (speed p=0.055, accuracy p=0.052) and increase in effect size by 86% and 157% respectively.

This analysis of Phase 1 data in healthy participants demonstrates the ability of eXplainable AI tools, such as KEM®, to integrate and analyze broad and heterogeneous sources of data from different trials, to provide insight into a drug’s mechanism of action, to generate testable hypotheses, and to guide the optimal design of the next steps in clinical development.

“We are very pleased to report initial results from our collaboration with the Cyclerion team that illustrate the power of integrating our xAI driven approach very early in clinical development. Our first evidence of clinical improvement of endpoints relevant in multiple diseases as well as the systematic identification of candidate patient selection criteria will help the design of next-phase studies with higher probability of success” commented Mohammad Afshar, Elara Pharmaceuticals Ltd CEO.

References:

    • – ClinicalTrials.gov Identifiers: NCT03856827, NCT04240158
      • – Poster: CY6463 administration in healthy participants was associated with improvements in Alzheimer’s disease relevant biomarkers based on a systematic analysis of multiple Phase 1 clinical trials using KEM® eXplainable AI.download here

      • – Download the Press Release here


For further information, please contact:  Email: info@elarapharma.com

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. 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 
Elara Pharmaceuticals Ltd Media
Thomas Turcat
t.turcat@elarapharma.com

Elara Pharmaceuticals Ltd Business Development
Marion Soto, Vice President, Business Development
m.soto@elarapharma.com

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]]> Towards a first precision medicine treatment of Alzheimer’s disease using Tersan’s Explainable AI. https://www.elarapharma.com/towards-a-first-precision-medicine-treatment-of-alzheimers-disease-using-arianas-explainable-ai/?utm_source=rss&utm_medium=rss&utm_campaign=towards-a-first-precision-medicine-treatment-of-alzheimers-disease-using-arianas-explainable-ai Fri, 17 Apr 2020 17:21:00 +0000 http://localhost/wp_theme/laborex/2021/05/06/hello-world-copy/ Paris and Boston, April 17th 2020. Tersan® Pharma, a leading digital health company announced today the publication of the first reported genome-wide search for biomarkers associated with drug response in Alzheimer’s disease in the Alzheimer’s & Dementia: Translational Research & Clinical Interventions journal. Using Tersan’s proprietary KEM® (Knowledge Extraction and Management) advanced Artificial Intelligence technology, […]

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Paris and Boston, April 17th 2020. Tersan® Pharma, a leading digital health company announced today the publication of the first reported genome-wide search for biomarkers associated with drug response in Alzheimer’s disease in the Alzheimer’s & Dementia: Translational Research & Clinical Interventions journal.

Using Tersan’s proprietary KEM® (Knowledge Extraction and Management) advanced Artificial Intelligence technology, starting with a small data rich open label one-year (57 weeks) clinical study of 32 well-characterized patients, was able to identify strong genomic biomarker hypothesis identifying patients with the highest chance of benefiting from the drug. The biomarker hypothesis was further confirmed through the additional 2-year (148 weeks) extension study.

The analysis of the longitudinal 3-year (148-week) data shows that patient cohort with the higher concentration of ANAVEX®2-73 maintains Activities of Daily Living Score (ADCS-ADL) and display a reduced cognitive decline (MMSE) when compared to the lower concentration cohort.

“This study highlights the relevance of phenotypic and genotypic precision medicine analyses of Whole Exome Sequencing (WES) and gene expression (RNAseq) data in drug development and in particular the potential to identify patients’ genetic variants and gene expression changes that may predict increased chances of success of Alzheimer’s disease treatments,” said Dr. Harald Hampel, M.D., Ph.D., M.A., M.Sc., Founding President of the Alzheimer Precision Medicine Initiative (APMI)

The authors note that Tersan’s KEM® explainable Artificial Intelligence “platform described in this work opens the possibility of using data-driven unbiased biomarker identification early in the drug development process”, even using small cohorts. “The “white box” and systematic approach (…) is ideal for the analysis of early data, leading to the identification of patient selection biomarkers that can assist in the design of more effective subsequent clinical trials.”

“We believe that the analysis platform described in this work opens the possibility of using big data-driven unbiased genome-wide patient selection marker identification early on in the drug development process of CNS diseases, including Alzheimer’s disease, which is currently applied more routinely in the field of oncology,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex.

KEM® (Knowledge Extraction and Management) is a comprehensive and FDA-tested Explainable Artificial Intelligence (XAI) data analytics platform that enables full exploitation of complex datasets. It has uniquely demonstrated its ability to extract biomarkers and identify alternative indications from small sets of patients, in multiple therapeutic areas including cancer, CNS, metabolic and immunological diseases.

About Elara Pharmaceuticals Ltd

Elara Pharmaceuticals Ltd is a leading digital health Company focused on developing advanced therapeutic decision support systems. Using its KEM® Explainable Artificial Intelligence (XAI) technology, Tersan helps its partners introduce personalized medicine clinical trial design into their protocols and identify the best clinical endpoints, the best responders and the best potential synergistic drugs. Tersan routinely collects and combines clinical data with omic data, immunological readouts (such as FACS), microbiota, Patient Reported Outcomes as well as Real World Evidence data. Combining advanced data analytics with regulatory expertise, Tersan helps translate findings into innovative clinical plans. With a growing number of successful therapeutic development applications, KEM® is the only FDA-reviewed 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 treatment selection 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.

Link to publication : “A precision medicine framework using Artificial Intelligence for the identification and confirmation of genomic biomarkers of response to an Alzheimer’s disease therapy: Analysis of the Blarcamesine (ANAVEX2-73) Phase 2a clinical study.“

 
 

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]]> Alzheimer’s Disease/Dementia Early Detection and Precision Medicine Using KEM® Artificial Intelligence (AI): latest research results presented by ARIANA at the AAIC 2019. https://www.elarapharma.com/alzheimers-disease-dementia-early-detection-and-precision-medicine-using-kem-artificial-intelligence-ai-latest-research-results-presented-by-ariana-at-the-aaic-2019/?utm_source=rss&utm_medium=rss&utm_campaign=alzheimers-disease-dementia-early-detection-and-precision-medicine-using-kem-artificial-intelligence-ai-latest-research-results-presented-by-ariana-at-the-aaic-2019 Mon, 29 Jul 2019 14:00:00 +0000 https://www.elarapharma.com/?p=4491 Gut Microbiota biomarkers associated with improved drug response, as well as genomic biomarkers for early detection of patients at risk were identified using Tersan’s KEM® Explainable AI (XAI) in 3 separate oral presentations. response, as well as genomic biomarkers for early detection of patients at risk were identified using Tersan’s KEM® Explainable AI (XAI) in […]

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Gut Microbiota biomarkers associated with improved drug response, as well as genomic biomarkers for early detection of patients at risk were identified using Tersan’s KEM® Explainable AI (XAI) in 3 separate oral presentations. response, as well as genomic biomarkers for early detection of patients at risk were identified using Tersan’s KEM® Explainable AI (XAI) in 3 separate oral presentations.

Paris, France and Cambridge, MA – July 25th, 2019 – Elara Pharmaceuticals Ltd (Paris, France and Cambridge, MA), a leading digital health company focused on developing advanced Artificial Intelligence technologies for patient stratification in clinical trials, today announced that Elara Pharmaceuticals Ltd’s work was showcased during three oral presentations at the AAIC 2019 in Los Angeles, the world’s largest Alzheimer’s disease event.

Presentation 1 showcased new clinical data identifying gut microbiota biomarkers associated with improved clinical response in patients treated with ANAVEX®2-73, a novel class of orally available selective sigma-1 receptor agonist. A growing body of evidence identifies gut microbiota as a critical component of healthy brain function, characterized as the ‘gut-brain axis’. High relative abundance of one gut microbiota family and one genus linked to improved responses with ANAVEX®2-73. The effect may be reversal of the microbiota imbalances already documented in Alzheimer’s disease patients and have a homeostatic effect on the brain-gut-microbiota axis. [Anavex Press Release PDF]

                                               DR. Mohamad AFSHAR presenting data identifying gut microbiota biomarkers
                                          associated with improved clinical response in patients treated with ANAVEX®2-73

Presentations 2 and 3 provided results from a data-driven KEM® analyses of an extensively characterized cohort of subjects having subjective memory complaints (SMC), but not displaying cognitive or memory impairments. KEM® successfully identified genomic biomarkers linked to changes in cognitive tests [3] and brain images [4] characteristic of early impairment. “We identified an homozygous variant, in a gene involved in the Golgi apparatus, to be significantly linked with change of the resting state activity in the orbito-frontal cortex” stated Sylke Ingeborg Müller, PhD, Director Data Science at Elara Pharmaceuticals Ltd. “I strongly believe that unsupervised and explainable Artificial Intelligence are essential tools for uncovering hidden relations from complex datasets”. KEM® implements an unsupervised and explainable AI (XAI) approach to uncover pertinent and clinically actionable hypotheses from complex datasets integrating heterogeneous information.

About Elara Pharmaceuticals Ltd

Elara Pharmaceuticals Ltd is a leading digital health Company focused on developing advanced therapeutic decision support systems. Using its KEM® Explainable Artificial Intelligence (XAI) technology, Tersan helps its partners introduce personalized medicine clinical trial design into their protocols and identify best clinical endpoints, best responders and best potential synergistic drugs. Tersan routinely collects and combines clinical data with omic data, immunological readouts (such as FACS), microbiota, Patient Reported Outcomes as well as Real World Evidence data. Combining advanced data analytics with regulatory expertise, Tersan helps translate findings into innovative clinical plans. With a growing number of successful therapeutic development applications, KEM® is the only FDA-reviewed 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 treatment selection 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.

MORE INFORMATION ABOUT KEM® FRAMEWORK

Presentations details:

Presentation 1 : Exploring Gut Microbiota As a Source of Potential Biomarkers: Initial Results from the Anavex® 2-73 Alzheimer’s Disease Clinical Study [PDF]

Presentation 2 : Combining Omics and Imaging Data from SMC individuals, Artificial Intelligence Technology Identifies Genomic Biomarkers for Early Detection of Alzheimer’s Disease [PDF]

Presentation 3 : Combining Omics and Cognitive Tests Data from SMC individuals, Artificial Intelligence Technology Identifies Genomic Biomarkers for Early Detection of Alzheimer’s Disease [PDF]

Further readings:

Advancing Alzheimer’s Disease Treatment: Lessons from CTAD 2018. The Journal of Prevention of Alzheimer’s Disease (JPAD) – B. Vellas ; L.J. Bain ; J. Touchon ; P.S. Aisen (2019): . [PDF][external link]

Alzheimer’s Disease/Dementia Early Detection and Precision Medicine Using KEM® Artificial Intelligence (AI): latest research results presented by ARIANA at the AAIC 2019. [Press Release]

Contact Us

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]]> Tersan’s AI provides evidence for 3 years clinical efficacy of ANAVEX®2-73 Alzheimer’s targeted therapy @CTAD2018 https://www.elarapharma.com/arianas-ai-provides-evidence-for-3-years-clinical-efficacy-of-anavex2-73-alzheimers-targeted-therapy-ctad2018/?utm_source=rss&utm_medium=rss&utm_campaign=arianas-ai-provides-evidence-for-3-years-clinical-efficacy-of-anavex2-73-alzheimers-targeted-therapy-ctad2018 Mon, 29 Oct 2018 07:10:00 +0000 https://www.elarapharma.com/?p=5205 Precision medicine approach using Tersan’s AI KEM® shows that a small data rich open label clinical study of 32 well-characterized patients may be sufficient to identify strong biomarker hypothesis identifying patients with the highest chance of benefiting from the drug.   BARCELONA, October 26th, 2018. Dr Mohammad Afshar presented 3 years longitudinal data of clinical […]

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Precision medicine approach using Tersan’s AI KEM® shows that a small data rich open label clinical study of 32 well-characterized patients may be sufficient to identify strong biomarker hypothesis identifying patients with the highest chance of benefiting from the drug.

 

BARCELONA, October 26th, 2018. Dr Mohammad Afshar presented 3 years longitudinal data of clinical efficacy of ANAVEX®2-73 (Anavex Life Sciences, Nasdaq: AVXL), and confirmed role of patient selection genomic biomarkers, at the 2018 Clinical Trials on Alzheimer’s Disease Meeting (CTAD).

Using Tersan’s proprietary KEM® (Knowledge Extraction and Management) advanced Artificial Intelligence technology, the analysis of the longitudinal 3-year (148-week) data showed that patient cohort with the higher concentration of ANAVEX®2-73 maintains Activities of Daily Living Score (ADCS-ADL) and display a reduced cognitive decline (MMSE) when compared to the lower concentration cohort.

MMRM adjusted analysis demonstrates that High concentration cohort displays a staggering 88% ADCS-ADL response difference vs low concentration cohort

In contrast to the vast majority of communications at CTAD 2018, the presentation focused on a novel drug target (SIGMAR1), the use of genomic biomarkers, rather than surrogates of response, and demonstrated the ability of the precision medicine approach to confirm significant drug response effects. The observed 3-year effect was large: 88% improvement compared to lower dose for ADCS-ADL (p<0.0001) and 64 % less decline for MMSE (p<0.0008).

“We are excited to see our initial biomarker hypothesis confirmed at 148 weeks. The biomarkers were selected through a data driven unbiased systematic analysis of all available genomic and clinical data, identifying a genomic alteration of SIGMAR1, the putative target of ANAVEX 2-73. The consistency of the DNA and RNA data, as well as multiple end-points and time-points further strengthen this biomarker hypothesis.” Mohammad Afshar, MD, PhD, CEO of Elara Pharmaceuticals Ltd.“This innovative data analytics approach, using our KEM® Artificial Intelligence platform has the potential to expand the access to precision medicine and precision pharmacology for a wide range of neurodegenerative diseases, thus, identifying the right patients that can benefit from the right therapy, at the right moment.” he added.

 

Given the current gloom from negative results of late stage clinical trials built on the prevailing amyloid paradigm, which have reported non-conclusive results or worse, have demonstrated negative impact, the novel therapy approach taken by Anavex, using a novel target SIGMAR1 and genomic inclusion biomarkers selected using the KEM Artificial Intelligence platform, brings hope to the field.

“These results further confirm the impact of actionable genetic variants that were previously identified through a full, unbiased genomic analysis of ANAVEX®2-73 in Alzheimer’s disease, raising optimism for the future of biomarker-guided precision medicine to effectively combat 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. He is the speaker of the Alzheimer Precision Medicine Initiative (APMI).
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M. Afshar, MD, PhD, CEO of Elara Pharmaceuticals Ltd, presenting presenting Anavex(R) 2-73 results at CTAD 2018

 

“We are encouraged by these data which now show the clinical impact of ANAVEX®2-73 on patients who have been receiving therapy for almost three years,” Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “We continue to build on the body of clinical evidence to support the development of ANAVEX®2-73 as we further our recently initiated Phase 2b/3 study, and we will continue our targeted precision medicine approach to advance ANAVEX®2-73 as a potential therapeutic option for patients with Alzheimer’s disease who will most benefit from treatment.”
 
 
More Information about KEM AI

Further Readings:

Press Release – Anavex Life Sciences Presents New Three-Year, Longitudinal Clinical Efficacy Data for ANAVEX®2-73 in Alzheimer’s Disease at the 2018 Clinical Trials on Alzheimer’s Disease (CTAD) Meeting. (Anavex press release)



2018 CTAD CORPORATE PRESENTATION – Longitudinal 148-Week Update of ANAVEX®2-73 Phase 2a Alzheimer’s Disease Extension Study. (Presentation PDF)

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]]> Artificial Intelligence enables first biomarker driven precision medicine therapy against Alzheimer https://www.elarapharma.com/artificial-intelligence-enables-first-biomarker-driven-precision-medicine-therapy-against-alzheimer/?utm_source=rss&utm_medium=rss&utm_campaign=artificial-intelligence-enables-first-biomarker-driven-precision-medicine-therapy-against-alzheimer Wed, 19 Sep 2018 19:27:00 +0000 https://www.elarapharma.com/?p=5230 Elara Pharmaceuticals Ltd helps ANAVEX® demonstrate efficacy of its Alzheimer’s therapy in phase 2a clinical trial. Tersan’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. Professor Harald Hampel, M.D., Ph.D., presenting results at the AAIC […]

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Elara Pharmaceuticals Ltd helps ANAVEX® demonstrate efficacy of its Alzheimer’s therapy in phase 2a clinical trial.

Tersan’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.


Professor Harald Hampel, M.D., Ph.D., presenting results at the AAIC 2018

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 Tersan 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 Tersan’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, Tersan’s expertise spans multiple medical indications and therapeutic areas, including cancer, metabolic and immunological diseases.

Discover how KEM® can help your company

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 Elara Pharmaceuticals Ltd 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 Elara Pharmaceuticals Ltd [Link: Document]

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]]> Applying the cancer playbook to find treatment for Alzheimer’s disease https://www.elarapharma.com/applying-the-cancer-playbook-to-find-treatment-for-alzheimers-disease/?utm_source=rss&utm_medium=rss&utm_campaign=applying-the-cancer-playbook-to-find-treatment-for-alzheimers-disease Wed, 01 Aug 2018 21:02:00 +0000 https://www.elarapharma.com/?p=5243 Applying the cancer playbook to find treatment for Alzheimer’s disease: see how Tersan’s KEM Artificial Intelligence platform is helping Anavex Life Sciences develop the first targeted therapy against Alzheimer’s disease.   “NEW YORK – July 25, 2018 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics […]

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Applying the cancer playbook to find treatment for Alzheimer’s disease: see how Tersan’s KEM Artificial Intelligence platform is helping Anavex Life Sciences develop the first targeted therapy against Alzheimer’s disease.

 

“NEW YORK – July 25, 2018 – 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, Rett syndrome and other central nervous system (CNS) diseases, today reported results of the entire genome DNA and RNA evaluation of study participants in a 57-week Phase 2a Alzheimer’s disease study investigating ANAVEX®2-73, a selective sigma-1 receptor agonist, resulting in the analysis of 33,311 genes and 860 pathways. Additionally, direct target occupancy of ANAVEX®2-73 at the sigma-1 receptor using quantitative Positron emission tomography (PET) scanning was presented.“ [Link: Anavex]

Presentations

– 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]

– 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]

Contact Us

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]]> CTAD 2017 (Boston, USA | 1-4 Nov) https://www.elarapharma.com/ctad-2017-boston-usa-1-4-nov/?utm_source=rss&utm_medium=rss&utm_campaign=ctad-2017-boston-usa-1-4-nov Sat, 04 Nov 2017 21:31:00 +0000 https://www.elarapharma.com/?p=5272 Dr Mohammad Afshar (Tersan CEO) is presenting on the analysis of Phase 2a trial results using Tersan’s KEM® artificial intelligence platform at CTAD 2017 (10th Clinical Trials on Alzheimer’s Disease) in Boston, USA on 4 November. LB18 – Clinical Pharmacokinetics and Pharmacodynamics Characterization of ANAVEX™2-73 for Designing a Phase 2/3 Study in Mild-to-Moderate Alzheimer’s Disease […]

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Dr Mohammad Afshar (Tersan CEO) is presenting on the analysis of Phase 2a trial results using Tersan’s KEM® artificial intelligence platform at CTAD 2017 (10th Clinical Trials on Alzheimer’s Disease) in Boston, USA on 4 November.

LB18 – Clinical Pharmacokinetics and Pharmacodynamics Characterization of ANAVEX™2-73 for Designing a Phase 2/3 Study in Mild-to-Moderate Alzheimer’s Disease
Mohammad Afshar, MD, PhD[1], Sylke Ingeborg Müller, PhD[1], Ene I Ette, PhD[2], Emmanuel O Fadiran, PhD[3], Christopher U Missling, PhD[3]
[1]Elara Pharmaceuticals Ltd, Paris, France, [2]Anoixis Corp., Natick, MA, [3]Anavex Life Sciences Corp., New York, NY

Links: Download Press Release | Download Presentation

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]]> Anavex incorporating Tersan’s KEM® AI platform in Alzheimer’s precision medicine approach https://www.elarapharma.com/anavex-incorporating-arianas-kem-ai-platform-in-alzheimers-precision-medicine-approach/?utm_source=rss&utm_medium=rss&utm_campaign=anavex-incorporating-arianas-kem-ai-platform-in-alzheimers-precision-medicine-approach Thu, 12 Oct 2017 21:35:00 +0000 https://www.elarapharma.com/?p=5278 Anavex Life Sciences Reports PK and PD Data from Phase 2a Trial of ANAVEX®2-73 in Mild-to-Moderate Alzheimer’s Disease PatientsANAVEX2-73 demonstrates desirable PK/PD properties, describing the relationship between drug concentration and the effect observed.Anavex is incorporating advanced Artificial Intelligence platform for the analysis of Phase 2a results with the aim to increase the chances of success […]

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Anavex Life Sciences Reports PK and PD Data from Phase 2a Trial of ANAVEX®2-73 in Mild-to-Moderate Alzheimer’s Disease Patients
ANAVEX2-73 demonstrates desirable PK/PD properties, describing the relationship between drug concentration and the effect observed.
Anavex is incorporating advanced Artificial Intelligence platform for the analysis of Phase 2a results with the aim to increase the chances of success in forthcoming Phase 2/3 study.

NEW YORK, October 12, 2017 – Anavex Life Sciences Corp. (Nasdaq: AVXL) today announced pharmacokinetic (PK) and pharmacodynamic (PD) data for ANAVEX2-73 from its positive Phase 2a study in mild-to-moderate Alzheimer’s disease patients. ANAVEX2-73 targets the sigma-1 receptor, which regulates neuroplasticity and cellular homeostasis. Anavex previously reported the Phase 2a trial successfully achieved both primary and secondary endpoints at the pre-specified 57-week analysis.

 

Data announced today establishes a clear concentration-effect relationship between ANAVEX2-73 and study measurements. These measures obtained from all patients during 57 weeks include cognitive and functional scores as well as a biomarker signal of brain activity. Additionally, ANAVEX2-73 activity appears to be enhanced by its active metabolite (ANAVEX19-144), which also targets the sigma-1 receptor with a half-life approximately twice as long as the parent molecule.

“I welcome such a thorough analysis of data before moving into a Phase 2/3. The intriguing ANAVEX2-73 data shown thus far exemplifies a precision medicine approach, to my knowledge, the first of its kind to broaden the scope of drug development in Alzheimer’s disease and other central nervous system diseases,” said George Perry, PhD, Dean of the College of Sciences at The University of Texas at San Antonio and editor-in-chief of the Journal of Alzheimer’s Disease.

The Company is identifying the best responders to ANAVEX2-73 by using Elara Pharmaceuticals Ltd’s KEM® advanced Artificial Intelligence technology. This cutting edge trial analysis will be used to more effectively design the upcoming Phase 2/3 clinical study, raising the odds of late stage trial success.

“We continue to be encouraged by the data from our Phase 2a clinical trial for ANAVEX2-73,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “We believe that through a systematic analysis of ANAVEX2-73 we might be able to increase the potential impact ANAVEX2-73 may have on this devastating condition.”

On the conference call scheduled for this morning, Christopher U Missling, PhD, President and Chief Executive Officer of Anavex will be joined by Professor George Perry, PhD and Mohammad Afshar, MD, PhD, President and CEO of Elara Pharmaceuticals Ltd to discuss new findings from the ANAVEX2-73 Phase 2a trial. Further data will be presented at the Clinical Trials on Alzheimer’s Disease (CTAD) meeting in November 2017.

Conference call and webcast information
Anavex will host a conference call at 8:30 a.m. ET today, October 12, 2017. The call will be webcast live at http://www.wsw.com/webcast/cc/avxl2 and slides are accessible through the investor relations section of the Company’s website at www.anavex.com. To join the call live via telephone dial 1-866-866-1333 within the United Kingdom or 1-404-260-1421 from outside the United Kingdom. A replay of the call will also be available for a period of three months through the Company’s website shortly after the call.

About ANAVEX®2-73 Phase 2a Clinical Study
The multicenter Phase 2a clinical trial of ANAVEX 2-73 consisted of two parts and a total of 32 mild-to-moderate Alzheimer’s patients. PART A was a simple randomized, open-label, two-period, cross-over between oral (30mg/50mg) and IV (3mg/5mg) administration, adaptive trial lasting up to 5 weeks for each patient. PART B was an open-label extension for an additional 52 weeks. Initially planned for 26 weeks, PART B was extended to 52 weeks as a result of requests from patients and caregivers.
The primary endpoint of the Phase 2a trial was safety, tolerability and maximum tolerated dose (MTD) of ANAVEX2-73, which had shown potential in preclinical studies to prevent, halt and/or reverse the course of the disease. Secondary endpoints included dose response, bioavailability, and exploratory cognitive as well as functional measures using Mini Mental State Examination (MMSE) and evaluation of Alzheimer’s Disease Co-operative Study – Activities of Daily Living Inventory (ADCS-ADL), as well as Cogstate test battery and biomarker EEG/ERP.

About Elara Pharmaceuticals Ltd
Tersan® Pharma is a leading digital health Company focused on developing advanced therapeutic decision support systems. Tersan’s innovative clinical data analysis and diagnostic testing solutions help the healthcare sector better adapt patient treatments to individual biological characteristics. Elara Pharmaceuticals Ltd’s KEM® technology enables personalization of therapies, improves the efficacy and safety of patient treatment, reduces risks and drug development costs, and accelerates time to market. KEM® is the only FDA-tested 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 treatment selection system. Founded in 2003 as a spin-off of the Institut Pasteur, Paris, France, the company opened a subsidiary in the United Kingdom in 2012. Further information is available at www.elarapharma.com.

About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of 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. Anavex’s lead drug candidate, ANAVEX®2-73, recently completed successfully a Phase 2a clinical trial for Alzheimer’s disease. ANAVEX®2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson’s Research has awarded Anavex a research grant to develop ANAVEX®2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEX®2-73 into a Parkinson’s disease clinical trial. ANAVEX®3-71, also targeting sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease modifications against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also with beneficial effects on neuroinflammation and mitochondrial dysfunctions. Further information is available at www.anavex.com. You can also connect with the company on Twitter, Facebook and LinkedIn.

Forward Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

For Further Information:

Anavex Life Sciences Corp.

Research & Business Development
Toll-free: 1-844-689-3939
Email: info[at]anavex.com

Investors & Media:

Clayton Robertson
The Trout Group
(646) 378-2900
crobertson[at]troutgroup.com

Links: Download Press Release | Download Presentation

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]]> Anavex and Elara Pharmaceuticals Ltd Collaborate to Accelerate Timelines and Improve Efficiency of Alzheimer’s and Parkinson’s Clinical Development Programs https://www.elarapharma.com/anavex-and-ariana-pharma-collaborate-to-accelerate-timelines-and-improve-efficiency-of-alzheimers-and-parkinsons-clinical-development-programs/?utm_source=rss&utm_medium=rss&utm_campaign=anavex-and-ariana-pharma-collaborate-to-accelerate-timelines-and-improve-efficiency-of-alzheimers-and-parkinsons-clinical-development-programs https://www.elarapharma.com/anavex-and-ariana-pharma-collaborate-to-accelerate-timelines-and-improve-efficiency-of-alzheimers-and-parkinsons-clinical-development-programs/#respond Wed, 05 Oct 2016 22:00:00 +0000 https://www.elarapharma.com/?p=5319 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 […]

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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.

Links: Download Anavex Press Release

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