A systematic analysis of both trials using Ariana’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.
Ariana’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, Ariana Pharma CEO.
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Ariana Pharma is a leading Artificial Intelligence (AI) drug development company. Using its KEM® Artificial Intelligence (xAI) technology, Ariana 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.
Ariana 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, Ariana 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 States since 2012.
Further information is available at www.arianapharma.com
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Marion Soto, Vice President, Business Development